Product Title and Initial U.S. 

Approval in the Highlights of 

Prescribing Information for Human 

Prescription Drug and Biological 

Products  Content and Format 

Guidance for Industry 

 
 
DRAFT GUIDANCE
  
 
  This guidance document is being distributed for comment purposes only. 
 
Comments and suggestions regarding this draft document should be submitted within 60 days of 
publication in the Federal Register of the notice announcing the availability of the draft 
guidance. Submit electronic comments to https://www.regulations.gov.  Submit written 
comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD  20852. All comments should be identified with the 
docket number listed in the notice of availability that publishes in the Federal Register. 
 
For questions regarding this draft document, contact (CDER) Debra Beitzell at (301) 796-0900, 
or (CBER) the Office of Communication, Outreach, and Development at 800-835-4709 or 240-
402-8010. 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 

Food and Drug Administration 

Center for Drug Evaluation and Research (CDER)
  
Center for Biologics Evaluation and Research (CBER) 
 
 
January 2018 

Labeling 

10253dft.docx  
12/15/17   Product Title and Initial U.S. 

Approval in the Highlights of 

Prescribing Information for Human 

Prescription Drug and Biological 

Products  Content and Format 

Guidance for Industry 

 
 
Additional copies are available from: 

 
Office of Communications, Division  of Drug Information 

Center for Drug Evaluation  and Research 

Food and  Drug Administration 
 
10001 New Hampshire Ave., Hillandale Bldg., 4th Floor  
 
Silver Spring, MD  20993-0002  

Phone: 855-543-3784 or 301-796-3400;  Fax: 301-431-6353;  Email: druginfo@fda.hhs.gov 
 
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm 

 
and/or 
 
 
Office of Communication, Outreach, and Development  

Center for Biologics Evaluation and Research 
 
Food and  Drug Administration
  
10903 New Hampshire Ave., Bldg. 71, rm. 3128 

Silver Spring, MD   20993-0002 

Phone: 800-835-4709 or 240-402-8010;  Email: ocod@fda.hhs.gov  

https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm 

 
 
 
 
 
 
U.S. Department of Health and Human Services 

Food and Drug Administration 

Center for Drug Evaluation and Research (CDER)
  
Center for Biologics Evaluation and Research (CBER) 
 
 
January 2018 

Labeling 

   
TABLE OF CONTENTS 
 
 
I.   INTRODUCTION............................................................................................................. 1
  
II.   BACKGROUND ............................................................................................................... 2
  
III.   SOURCES FOR PRODUCT TITLE TERMINOLOGY .............................................. 3
  
A.   Drug Names .................................................................................................................................... 3
  
1.  Proprietary Name ............................................................................................................................ 3
  
2.  Nonproprietary Name ...................................................................................................................... 3
  
a. 	  Nonproprietary  name of drug products approved under the Federal Food, Drug, and  

Cosmetic Act ............................................................................................................................. 3
  
b. 	  Nonproprietary  name of biological products licensed under the Public Health Service Act .... 4 
 
B.   Dosage Form................................................................................................................................... 4
  
C.   Route of Administration ................................................................................................................ 4
  
D.   Controlled Substance Symbol....................................................................................................... 5
  
IV.   PRODUCT TITLE CONTENT AND FORMAT .......................................................... 5 
 
A.   Basic Format  .................................................................................................................................. 5
  
B.   Drug Names .................................................................................................................................... 6
  
1.  General Format ............................................................................................................................... 6
  
a.  	 Display of the proprietary name  ................................................................................................ 6
  
b. 	  Display of the nonproprietary name  for nonbiological drug products ...................................... 6 
 
c.  	 Display of the nonproprietary (proper) name for biological products  ...................................... 6 
 
d. 	  Special considerations for nonproprietary names of drug products that contain a salt ............. 7 
 
2.  Fixed-Combination Drug Products ................................................................................................. 7
  
3.  Drug Products Without Proprietary Names .................................................................................... 7 
 
C.   Dosage Form................................................................................................................................... 8 
 
1.  General Format ............................................................................................................................... 8 
 
2.  Multiple Dosage Forms ................................................................................................................... 8
  
3.  Dosage Form Descriptors................................................................................................................ 8
  
4.  Drug Products Requiring Reconstitution ......................................................................................... 9 
 
5.  Injectable Drug Products................................................................................................................. 9
  
6.  Drug Delivery Systems..................................................................................................................... 9
  
D.   Route of Administration .............................................................................................................. 10 
 
1.  General Format ............................................................................................................................. 10 
 
2.  Injectable Drug Products............................................................................................................... 10 
 
3.  Multiple Routes of Administration ................................................................................................. 11 
 
4.  Intravenous Methods...................................................................................................................... 11 
 
5.  Inhaled Drug Products .................................................................................................................. 11 
 
E.   Drug Products With Special Nomenclature Considerations .................................................... 11 
 
1.  Infusion Solutions .......................................................................................................................... 11 
 
2.  Co-Packaged Drug Products ......................................................................................................... 12 
 
3.  Lipid Complexes ............................................................................................................................ 13 
 
4.  Liposomes ...................................................................................................................................... 14 
 
5.  Radiopharmaceuticals ................................................................................................................... 14 
 
a.  	 General format ........................................................................................................................ 14 
 
i 
   
b.   Radionuclide generator and associated drug product nomenclature ....................................... 15 
 
F.   Controlled Substance Symbol..................................................................................................... 16 
 
V. 	  ITEMS THAT SHOULD NOT BE INCLUDED IN THE PRODUCT TITLE ........ 17 
 
VI. 	  PRODUCT TITLE AND IMPLICATIONS FOR CONTAINER AND CARTON  

LABELING ..................................................................................................................... 18 
 
VII. 	  INITIAL U.S. APPROVAL ........................................................................................... 19 
 
A.   Active Moiety................................................................................................................................ 19 
 
B.   Multiple Dosage Forms................................................................................................................ 19 
 
C.   Fixed-Combination Drug Products and Co-Packaged Drug Products ................................... 20 
 
D.   Controlled Substances ................................................................................................................. 20 
 
E.   Racemates ..................................................................................................................................... 20 
 
F.   Drug Efficacy Study Implementation Drugs ............................................................................. 21 
 
G.   Approval of Previous Marketed Unapproved Drugs ................................................................ 21 
 
H.   Previously Approved Drug Product Reintroduced Into Market ............................................. 21 
 
GLOSSARY................................................................................................................................. 22 
 
APPENDIX A:  DOSAGE FORM TERMS FOR USE IN HUMAN DRUG PRODUCT 

LABELING ................................................................................................................................. 24 
 
APPENDIX B:  ROUTE OF ADMINISTRATION TERMS FOR USE IN THE 
  
PRODUCT TITLE...................................................................................................................... 36 
 
 
ii  
  Contains Nonbinding Recommendations 
Draft  Not for Implementation  
Product Title and Initial U.S. Approval in the Highlights of 
1 
Prescribing Information for Human Prescription Drug and 
2 
Biological Products  Content and Format  
3 
Guidance for Industry1  
4 
5   
6   
7   
8   
9  This draft guidance, when finalized, will represent the current thinking of the Food and Drug 
10  Administration (FDA or Agency) on this topic.  It does not establish any rights for any person and is not 
11  binding on FDA or the public.  You can use an alternative approach if it satisfies the requirements of the 
12  applicable statutes and regulations. To  discuss an alternative approach, contact the FDA staff responsible 
13  for this guidance as listed on the title page. 
14   
15   
16   
17   
18  I.  INTRODUCTION  
19   
20  This guidance is intended to assist applicants in complying with certain labeling requirements for 
21  human prescription drug and biological products (21 CFR 201.56 and 201.57).2  This guidance 
22  provides recommendations for applicants developing labeling for new drugs and revising 
23  labeling for already approved drugs.  Specifically, this guidance provides recommendations on 
24  the content and format of the product title (21 CFR 201.57(a)(2))3 and initial U.S. approval 
25  (21 CFR 201.57(a)(3)) lines in the Highlights of Prescribing Information (Highlights) as 
26  described in 21 CFR 201.57(a).  This guidance provides recommendations on the content and 
27  format of the product title and year of initial U.S. approval to bring greater consistency to the 
28  presentation of these required elements in labeling and to help ensure these elements provide 
29  clear and useful information to the reader.  
                                                 
1  This guidance has been prepared by the Office of New Drugs in the Center for Drug Evaluation and Research in 
cooperation with the Center for Biologics Evaluation and  Research at the Food and Drug  Administration.   
 
2 For purposes of this  guidance, unless otherwise specified, references to  drugs and drug products include drugs 
approved under the Federal Food, Drug, and Cosmetic Act (FD&C  Act) and biological products licensed under the  
Public Health Service Act (PHS Act), other than devices regulated under a biologics license application. 
 
3  For purposes of  this guidance, product title is defined as those elements required in  21  CFR 201.57(a)(2)  (i.e., drug  
name(s), dosage form, route of administration, and, if applicable, controlled substance symbol).  See the guidance 
for industry  Labeling for Human Prescription  Drug  and Biological Products  Implementing the PLR Content and  
Format Requirements. There are also numerous other FDA guidances that address labeling, including prescription 
drug labeling,  at  
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm065010.htm.  We update 
guidances  periodically.  To make sure you  have the most recent version of a guidance, check the FDA Drugs 
guidance web page at  
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.  
 
1 
 Contains Nonbinding Recommendations 
Draft  Not for Implementation  
30   
31  The recommendations in this guidance apply only to the product title and initial U.S. approval in 
32  Highlights and do not apply to other parts of the prescribing information, or other types of 
33  labeling (e.g., container and carton labeling).  The recommendations in this guidance generally 
34  are applicable to biological products (see the Glossary) licensed under the Public Health Service 
35  Act (PHS Act), but for some biological products (e.g., vaccines, blood products, allergenic 
36  extracts, or cellular and gene therapy products) other approaches may be more appropriate 
37  because of those biological products special characteristics.  Applicants for these products 
38  should contact the applicable review division to discuss appropriate alternative approaches for 
39  complying with 21 CFR 201.57(a)(2).   
40   
41  Lists of dosage form and route of administration terms have been created to assist the reader in 
42  selecting proper terminology for use in the product title and other human drug product labeling.4   
43  These lists are provided in Appendix A, Dosage Form Terms for Use in Human Drug Product 
44  Labeling, and Appendix B, Route of Administration Terms for Use in the Product Title.  These 
45  appendixes will be updated as needed to add new or to revise existing terminology. 
46   
47  In general, FDAs guidance documents do not establish legally enforceable responsibilities.  
48  Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
49  as recommendations, unless specific regulatory or statutory requirements are cited.  The use of 
50  the word should in Agency guidances means that something is suggested or recommended, but 
51  not required. 
52   
53   
54  II.  BACKGROUND  
55   
56  In January 2006, the FDA published a final rule amending the requirements for the content and 
57  format of labeling for human prescription drug and biological products.5  This rule is commonly 
58  referred to as the physician labeling rule because it addresses prescription drug labeling that is 
59  used by physicians and other health care providers.  
60   
                                                 
4 The FDA identifies a list of drug  products approved  on the basis of safety and effectiveness in its publication  
Approved  Drug Products With Therapeutic Equivalence Evaluations, commonly referred to as the Orange Book. 
The Orange Book  uses uniform terms to designate  dosage  forms and routes of administration (those terms are listed 
in Appendix C of the Orange  Book).  To the extent that there are differences between the dosage forms and routes of 
administration  provided in this guidance and its appendixes and those listed in the current edition of the Orange  
Book, the Orange Book terms should  be consulted  for the purposes of section 505(j) of the FD&C Act and the 
FDAs implementing regulations (e.g., when determining whether drug products  have the same dosage  form and 
route of administration).  Additionally, this guidance is not intended to  be used in  determining  what constitutes a 
separate marketing application for assessing user fees (see the guidance for industry  Submitting Separate Marketing  
Applications and Clinical  Data for Purposes of Assessing  User Fees for details).  
 
5 See the final rule Requirements on  Content and Format of Labeling for Human Prescription Drug and Biological 
Products (71  FR 3922, January 24, 2006).  
 
2 
 Contains Nonbinding Recommendations 
Draft  Not for Implementation  
61  Under this rule, prescription labeling must contain three sections:  Highlights, Full Prescribing 
62  Information:  Contents, and Full Prescribing Information (21 CFR 201.56(d)(1)).  Highlights 
63  must contain the drugs proprietary name,6 nonproprietary name7 together with any appropriate 
64  descriptors, dosage form, route of administration, and the controlled substance symbol, if 
65  applicable (21 CFR 201.57(a)(2)).  This information follows the Highlights Limitation Statement 
66  (21 CFR 201.57(a)(1)) and is referred to as the product title in this guidance. Additionally, 
67  Highlights must include the year of the initial U.S. approval, which must be placed directly 
68  underneath the product title (21 CFR 201.57(a)(3)). 
69   
70   
71  III.  SOURCES FOR PRODUCT TITLE TERMINOLOGY  
72   
73  A.  Drug Names 
74   
75  1.  Proprietary Name   
76   
77  The proprietary name is the exclusive name of a drug product owned by a company under 
78  trademark law regardless of registration status with the U.S. Patent and Trademark Office.   
79   
80  2.  Nonproprietary Name 
81   
82  a.  Nonproprietary name of drug products approved under the Federal Food, 
83  Drug, and Cosmetic Act  
84   
85  The nonproprietary name of a drug product approved under the Federal Food, Drug, and 
86  Cosmetic Act (FD&C Act) is its established name (see the Glossary), which ordinarily will be 
87  the United States Pharmacopeia (USP) drug product monograph title for that drug product.8  If 
88  there is no USP monograph for the drug product under review, then the applicant should refer to 
89  21 CFR 299.4(e) (addressing established names for drugs) and the USP nomenclature guidelines 
90  as set forth in the USP General Chapter <1121> Nomenclature  for guidance.9   
91   
                                                 
6  For purposes of  this guidance, proprietary name  refers to  both the proprietary name of a drug  product  and to the 
trade name  of a biological product (see the Glossary).   The FDA recognizes that not  all products have a proprietary  
name. 
 
7  For purposes of  this guidance, nonproprietary name refers to  both the established name of a drug  product and to  
the proper name of a biological product except where indicated (see the Glossary).    
 
8 See section  502(e)(3) of the FD&C Act; 21  CFR 299.4. 
 
9 According to the USP Nomenclature Guidelines (http://www.usp.org) that are referenced in General Chapter 
<1121>, the general  format for a drug  product  monograph title is [DRUG][ROUTE OF  
ADMINISTRATION][DOSAGE FORM].  Early identification of unique considerations for any of the three 
components of  the  monograph title for a drug  product is important.   
 
3 
 Contains Nonbinding Recommendations 
Draft  Not for Implementation  
92  b.  Nonproprietary name of biological products licensed under the Public 
93  Health Service Act 
94   
95  For biological products licensed under the PHS Act, the nonproprietary name of the product that 
96  is to appear in the product title is the products proper name, which is the name designated in the 
97  license for use upon each package of the product.10   
98   
99  B.  Dosage Form 
100   
101  Applicants should refer to the USP as the source for dosage form terminology for use in the 
102  nonproprietary name portion of the product title in Highlights.11  Currently, this information is 
103  located in General Chapters <1151> Pharmaceutical Dosage Forms, <5> Inhalation and Nasal 
104  Drug Products  General Information and Quality Tests, and <1121> Nomenclature. The 
105  existing USP monograph titles for specific drug products also can be used as examples of 
106  appropriate dosage form terminology because, in some cases, the monographs for a new dosage 
107  form become official before incorporation of that new dosage form in one of the previously 
108  mentioned General Chapters.12  See Appendix A for a list of commonly used dosage form terms.  
109  This list was developed using information obtained from the USP General Chapters and 
110  monographs. In addition, it includes FDA-recommended terms that have not yet received full 
111  endorsement by the USP.  To assist the reader, older dosage form terms that are no longer used 
112  have been included on the list along with references to currently accepted terminology.  If an 
113  applicant determines that a term different from  any of the examples is appropriate, the applicant 
114  is encouraged to initiate discussions with the FDA as soon as possible. 
115   
116  The FDA Data Standards Manual (DSM) should not be used to select terminology for the dosage 
117  form of a drug product.  The DSM often uses more specific dosage form terminology than is 
118  recommended for product title purposes.  
119   
120  C.  Route of Administration 
121   
122  When the nonproprietary name does not include the route of administration, a route of 
123  administration must  be added to the product title in Highlights (21 CFR 201.57(a)(2)) (see 
124  section IV.D, Route of Administration).  Appendix B lists the most commonly used route of 
                                                 
10 See 21 CFR 600.3(k). 
 
11  When there is an applicable USP monograph title for the drug  product, applicants must use the monograph title as 
the source for dosage form terminology for use in the nonproprietary name portion  of the product title in Highlights 
(section 502(e) of the FD&C Act). 
  
12 Knowledge of the history of USP monographs is important when selecting  which monograph titles to  use as 
models.  USP notes in the USP Nomenclature Guidelines (http://www.usp.org) that are referenced in General 
Chapter <1121> that some existing monograph titles do not conform to the formats outlined in <1121> because the 
monograph titles were adopted before the establishment of the title formats and nomenclature policies set forth in 
<1121>.  USP advises that such monograph titles should not be interpreted as establishing a precedent for other 
monograph titles. 
 
4 
 Contains Nonbinding Recommendations 
Draft  Not for Implementation  
125  administration terms for use in the product title in Highlights.13  This list is derived from the 
126  FDA DSM Route of Administration list14 with minor differences made to create a list for use in 
127  the product title.   If an applicant determines that a route of administration term different from  
128  any of the examples is appropriate, the applicant is encouraged to initiate discussions with the 
129  FDA.  
130   
131  D.  Controlled Substance Symbol 
132   
133  The controlled substance schedule, and thus its symbol, is assigned by the Drug Enforcement 
134  Administration (DEA).  As described in 21 CFR parts 1302 and 1308, a drug may be assigned to 
135  controlled substance schedule I, II, III, IV, or V.   
136   
137   
138  IV.  PRODUCT TITLE CONTENT AND FORMAT  
139   
140  A.  Basic Format 
141   
142  The product title must include the drug name(s) (proprietary and nonproprietary), dosage form, 
143  route of administration, and, when applicable, controlled substance symbol (21 CFR 
144  201.57(a)(2)). 
145   
146  The entire product title must be in bold print (21 CFR 201.57(d)(5)).   The product title should be 
147  in the same type face and font size as the rest of Highlights.  The product title should be 
148  presented as continuous wrapping text to maintain consistency among all approved drug products 
149  and to preserve space in Highlights.15  Abbreviations should be avoided in the product title 
150  because they may be misread, increasing the risk of confusion or medication errors.    
151   
152  It should be noted that 21 CFR 201.57(a)(2) does not include the drug product strength as part of 
153  the product title. The regulations under 21 CFR 201.57(a)(8) require that the strength appear 
154  under the Dosage Forms and Strengths heading in Highlights.  Omitting strengths from the 
155  product title avoids clutter and redundancy within Highlights (see section V., Items That Should 
156  Not Be Included in the Product Title). 
157   
                                                 
13 Many  of the terms in Appendix B are also used  when including the route of administration in the nonproprietary 
name.  When there is an applicable USP monograph title for the drug product, applicants must use the  monograph 
title as the source for route of  administration  terminology for use in the nonproprietary name portion of the product 
title in Highlights (section 502(e) of the FD&C Act).  
 
14  
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/D 
ataStandardsManualmonographs/ucm071667.htm.  
 
15 In rare cases, such as for complex  product titles, it may be  preferable not to wrap the text  continuously for clarity.  
For example, the dosage form and route of  administration could be presented on the line beneath the drug  name(s).  
5 
 Contains Nonbinding Recommendations 
Draft  Not for Implementation  
158  B.  Drug Names  
159   
160  1.  General Format 
161   
162  a.  Display of the proprietary name  
163   
164  The proprietary name should appear in uppercase letters, regardless of how it is displayed 
165  elsewhere (e.g., on the container and carton labeling), to easily identify the drug product and 
166  distinguish it from the rest of the product title.   
167   
168  b.  Display of the nonproprietary name for nonbiological drug products 
169   
170  The nonproprietary name of a nonbiological drug product should appear in parentheses in 
171  lowercase letters.16  The FDA recommends two options for the placement of the parentheses 
172  around the nonproprietary name.  The option selected should correspond to the proprietary name  
173  that precedes it.  Examples provided throughout the guidance illustrate the two different 
174  approaches, which are as follows: 
175   
176  (1)  If the proprietary name corresponds to a drug product available in a single dosage form, 
177  the entire nonproprietary name including the dosage form and, when applicable, the route 
178  of administration should be included in the parentheses.    
179   
180  For example: 
181   
182  The drug name MYDRUG (drugozide nasal spray) indicates that the proprietary 
183  name MYDRUG is assigned only to the nasal spray dosage form.   
184   
185  (2)  If an applicant intends to market other dosage forms of the same active ingredient (see 
186  the Glossary) under the same proprietary name, only the reference to the chemical 
187  component portion of the nonproprietary name should appear within the parentheses.17    
188   
189  For example: 
190   
191  The drug name MYDRUG (drugozide) nasal spray indicates that the proprietary 
192  name MYDRUG may be assigned to multiple dosage forms.   
193   
194  c.  Display of the nonproprietary (proper) name for biological products 
195   
196  The proper names of biological products typically do not include a route of administration or 
197  dosage form. Therefore, the route of administration and/or dosage form should not be located 
                                                 
16 Exceptions  from  this approach may be appropriate for certain drug products (lipids, liposomes, and for isotope 
nomenclature as described in section IV.E., Drug Products  With Special  Nomenclature Considerations) and for  
certain accepted scientific terms (e.g., microbiologic nomenclature for a genus or serogroup). 
 
17 For a nonbiological drug  product, the name used for the chemical component (active ingredient  or active moiety) 
is selected based  on the recommendations set forth in  General Chapter <1121>.   
6 
 Contains Nonbinding Recommendations 
Draft  Not for Implementation  
198  inside the parentheses, as shown in the example in this subsection and subsequent similar 
199  examples throughout this guidance, to signify certain characteristics of a drug product.   
200   
201  For example:   
202   
203  MYDRUG (drugimab-cznm) injection, for subcutaneous use  
204   
205  d.  Special considerations for nonproprietary names of drug products that 
206  contain a salt 
207   
208  Applicants for new salt drug products should consult the General Chapter <1121> discussion of 
209  USPs naming policy for such drug products.  Under the USPs policy, the titles of USP 
210  monographs for drug products formulated with a salt of an acid or base typically use the name of 
211  the active moiety (e.g., MYDRUG (drugozide) tablets, for oral use), rather than the salt 
212  form (e.g., MYDRUG (drugozide hydrochloride) tablets, for oral use). There are 
213  exceptions to this general rule if the salt conveys vital clinical information, in which case the 
214  nonproprietary name should include the salt.18  The FDA also recommends that applicants for 
215  such drug products consult the relevant review division early in the development process for 
216  guidance on the appropriate nonproprietary name for such drug products.   
217   
218  2.  Fixed-Combination Drug Products 
219   
220  For purposes of this guidance, a fixed-combination drug product is one in which two or more 
221  active ingredients are combined at a fixed dosage in a single dosage form. 
222   
223  For fixed-combination drug products, the word and should be used to separate the active 
224  ingredients in the nonproprietary name.  Slash marks (/) should be avoided because they may be 
225  misread, leading to an increased risk of confusion and medication errors. 
226     
227  For example:   
228   
229  MYDRUG (drugozide and drugomycin capsules), for oral use  
230   
231  If there are more than two active ingredients, they should be written following the convention of  
232  a, b, and c. 
233   
234  For example:   
235   
236  MYDRUG (drugozide, drugomycin, and drugazole) capsules, for oral use 
237   
238  3.  Drug Products Without Proprietary Names 
239   
240  If the drug product does not have a proprietary name, the chemical component portion of the 
241  nonproprietary name should appear in all uppercase letters to easily identify the subject drug and 
                                                 
18 See the guidance for industry Naming of  Drug Products Containing Salt Drug Substances.    
7 
 Contains Nonbinding Recommendations 
Draft  Not for Implementation  
242  distinguish it from the rest of the product title, and the parentheses around the name should be 
243  omitted entirely.   
244   
245  For example:   
246   
247  DRUGOZIDE oral solution  
248  DRUGOZIDE tablets, for oral use  
249   
250  C.  Dosage Form 
251   
252  1.  General Format 
253   
254  The dosage form should appear in all lowercase letters.  The plural noun of the dosage form  
255  (e.g., lozenges) should be used unless the drug product is supplied only as a single unit (e.g., 
256  intravitreal insert).  
257   
258  2.  Multiple Dosage Forms 
259   
260  If the labeling discusses multiple dosage forms for a drug product under the same proprietary 
261  name, each dosage form should be presented on a separate line for ease of reading.  
262     
263  For example:   
264   
265  MYDRUG (drugozide) tablets, for oral use  
266  MYDRUG (drugozide) oral solution  
267  MYDRUG (drugozide) injection, for intravenous use   
268   
269  3.  Dosage Form Descriptors 
270   
271  The descriptors extended-release and  delayed-release are the only terms that should be used, if 
272  applicable, when describing a modified-release dosage form (see Appendix A).   
273   
274  For example:   
275   
276  MYDRUG (drugozide) delayed-release capsules, for oral use 
277  MYDRUG (drugozide) for extended-release oral suspension 
278   
279  If a fixed-combination drug product contains active ingredients with a combination of release 
280  characteristics, the nomenclature of the product should be based on the following principles: 
281   
282     A combination of immediate-release and extended-release is referred to as extended-
283  release  
284   
285     A combination of delayed-release and extended-release is referred to as extended-release   
286   
8 
 Contains Nonbinding Recommendations 
Draft  Not for Implementation  
287     A combination of immediate-release and delayed-release with at least one active 
288  ingredient exhibiting both release characteristics is referred to as extended-release 
289   
290     A combination of immediate-release and delayed-release with no active ingredient 
291  exhibiting both characteristics is referred to as delayed-release  
292   
293  4.  Drug Products Requiring Reconstitution  
294   
295  The use of the word for before a dosage form term should be used to describe a solid dosage 
296  form (e.g., lyophilized powder or granules) that requires reconstitution before administration (see 
297  Appendix A). 
298   
299  For example:   
300   
301  MYDRUG (drugozide) for oral suspension  
302  MYDRUG (drugozide) for injection, for intravenous use    
303   
304  5.  Injectable Drug Products  
305   
306  The dosage form  injection should be used for drug products available as solutions that will be 
307  injected, regardless of whether or not they need further dilution before administration.  The term  
308  injection assumes that the drug product is a solution, whereas for injection should be used when 
309  the drug product is a solid (e.g., lyophilized powder) that must be reconstituted before 
310  administration (see Appendix A).19  
311   
312  For example:   
313   
314  MYDRUG (drugozide injection), for intravenous use 
315  MYDRUG (drugozide) injectable suspension, for subcutaneous use 
316  MYDRUG (drugozide) for injectable suspension, for intramuscular use   
317   
318  6.  Drug Delivery Systems 
319   
320  If the drug product includes a delivery system (e.g., inhaler or pen injector), the system should 
321  not be included in the nonproprietary name because the delivery system generally is not part of 
322  the dosage form of a drug product.  Descriptions of delivery systems should be presented 
323  elsewhere in the labeling (e.g., in the DOSAGE AND ADMINISTRATION, DESCRIPTION, 
324  and HOW SUPPLIED/STORAGE AND HANDLING sections).   
325   
326  For example:   
327   
328  A drug product with a pen injector for subcutaneous administration should not include the 
329  delivery system in the product title (e.g., MYDRUG (drugozide) injection, for 
330  subcutaneous use).  
331   
                                                 
19 See General Chapter <1121> for additional information on  the nomenclature of injectable drug  products.   
9 
 Contains Nonbinding Recommendations 
Draft  Not for Implementation  
332  The proprietary name of a delivery system can be included in the product title if it is part of the 
333  official proprietary name of the drug product, and therefore can appear with the proprietary 
334  name.   
335   
336  For example:   
337   
338  MYDRUG NEWHALER (drugozide) inhalation solution, for oral inhalation use  
339   
340  D.  Route of Administration 
341   
342  1.  General Format 
343   
344  For most dosage forms other than tablets, capsules, and injections, the route of administration 
345  usually precedes the dosage form (see Appendix A for recommendations for dosage forms).  The 
346  route of administration need not be repeated if it precedes the dosage form. 
347   
348  For example:   
349   
350  MYDRUG (drugozide) otic solution   
351  MYDRUG (drugozide nasal spray)    
352   
353  When the dosage form is not preceded by the route of administration, the route should be 
354  presented as for [route] use, preceded by a comma, and should appear in all lowercase letters.    
355   
356  For example:   
357   
358  MYDRUG (drugozide) ointment, for topical use  
359  MYDRUG (drugozide tablets), for oral use  
360   
361  Because the product title cannot address all potential safety concerns and many drug products are 
362  administered by a single route, the word only should not appear with the route of 
363  administration (e.g., for topical use only).  However, omitting such descriptors from the product 
364  title is not intended to establish a precedent for how route of administration information should 
365  be presented elsewhere on the container and carton labeling (see section VI., Product Title and 
366  Implications for Container and Carton Labeling) and elsewhere in the prescribing information 
367  (e.g., in the DOSAGE AND ADMINISTRATION section). 
368   
369  2.  Injectable Drug Products  
370   
371  When the dosage form is an injection, the route of administration should follow the dosage form, 
372  preceded by a comma.  Abbreviations should be avoided in the product title because they may be 
373  misread, increasing the risk of confusion and medication errors.  For example, applicants should 
374  use the words intravenous or subcutaneous instead of IV or SC.  
375   
10 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation  
376  For example:   
377   
378  MYDRUG (drugozide) injection, for intramuscular use   
379   
380  3.  Multiple Routes of Administration 
381   
382  If a drug product has more than one route of administration, the word or should be used to 
383  separate two routes. For more than two routes of administration, the convention of a, b, or c 
384  should be followed. 
385     
386  For example:   
387   
388  MYDRUG (drugozide) injection, for intramuscular, subcutaneous, or intravenous use  
389   
390  4.  Intravenous Methods 
391   
392  For drugs that are administered by specific intravenous methods (e.g., intravenous push or 
393  intravenous infusion), the route of administration should remain for intravenous use because 
394  21 CFR 201.57(a)(2) does not specify methods of administration as an element of the product 
395  title. Additional descriptors of the method should be included elsewhere in labeling (e.g., 
396  presented prominently under the Dosage and Administration heading in Highlights) to help 
397  ensure safe use of the drug. Additionally, container and carton labeling can include such 
398  descriptors (e.g., for intravenous infusion instead of for intravenous use) (see section VI., 
399  Product Title and Implications for Container and Carton Labeling).  
400   
401  5.  Inhaled Drug Products 
402   
403  Inhaled drug products are unique because the definition of the route of administration term  
404  inhalation is used for drug products approved for both oral and nasal use. Therefore, the precise 
405  inhalation route (i.e., oral inhalation, nasal inhalation, or simply inhalation if both uses are 
406  approved) should be included in the product title (see Appendix B).  This is an exception to the 
407  recommendation that the route need not be repeated if it is part of the nonproprietary name (see 
408  section IV.D.1., General Format). 
409   
410  For example:   
411   
412  MYDRUG (drugozide) inhalation aerosol, for oral inhalation use 
413  MYDRUG (drugozide) inhalation solution, for inhalation use  
414   
415  E.  Drug Products With Special Nomenclature Considerations 
416   
417  1.  Infusion Solutions 
418   
419  Premixed drug products for infusion should have nonproprietary names formatted as [drug] in 
420  [vehicle] injection. Examples of names of drug products for infusion as they should appear in 
421  the product title are given below. 
11 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation  
422   
423  For example:   
424   
425  MYDRUG (drugozide in dextrose injection), for intravenous use 
426  MYDRUG (drugozide in dextrose and sodium chloride injection), for intravenous use 
427   
428  Premixed drug products for infusion that do not have a proprietary name should be named using 
429  the format described under section IV.B.3., Drug Products Without Proprietary Names.  For 
430  example: 
431   
432  DRUGOZIDE IN DEXTROSE injection, for intravenous use  
433   
434  The strength of the vehicle should not be included in the product title.  However, on container 
435  and carton labeling, the strength of the vehicle(s) should be stated as if part of the nonproprietary 
436  name (e.g., 5% Dextrose Injection, or Dextrose Injection 5%; 5% Dextrose and 0.2% Sodium  
437  Chloride Injection, or Dextrose (5%) and Sodium Chloride (0.2%) Injection).  
438   
439  Injectable drug products that are packaged in combination with an infusion solution in a manner 
440  that does not allow for separate use of either product and are therefore intended to be mixed 
441  together (i.e., admixed) before use should be named using the format for combination products 
442  (see section IV.B.2., Fixed-Combination Drug Products).  An example of a product title for a 
443  dual chamber container that contains a lyophilized powder in one chamber and the infusion 
444  solution in another chamber is given below.   
445   
446  For example:   
447   
448  MYDRUG (drugozide for injection and dextrose injection), for intravenous use 
449   
450  For more complicated infusion solutions (e.g., three or more drug products in a closed, 
451  multichamber container that is mixed before administration), we encourage applicants to contact 
452  FDA review staff to determine the presentation of the product title. 
453   
454  2.  Co-Packaged Drug Products  
455   
456  For purposes of this guidance, a co-packaged drug product is a product that contains two or more  
457  separate drugs in their final dosage forms that are intended to be used together for a common or 
458  related therapeutic purpose and that are contained in a single package or unit. 
459   
460  The dosage forms (and, if applicable as described in this guidance, the route of administration 
461  (see section IV.D., Route of Administration)) generally should appear within the nonproprietary 
462  name for clarity.  Also, for such drug products, a semicolon should be used between the 
463  nonproprietary names instead of the word and to differentiate co-packaged drug products from  
464  fixed-combination drug products.  The word co-packaged should appear after the 
465  nonproprietary names. 
466   
12 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation  
467  The route of administration should be included after the parentheses as recommended in section 
468  IV.D., Route of Administration.   
469   
470  For example:   
471   
472  MYDRUG (drugozide tablets; drugomycin capsules), co-packaged for oral use 
473  MYDRUG (drugozide oral solution; drugomycin tablets), co-packaged for oral use 
474   
475  However, if each co-packaged drug product has the route of administration preceding the dosage 
476  form, the routes of administration need not be repeated in the product title. 
477   
478  For example:   
479   
480  MYDRUG (drugozide oral solution; drugomycin oral suspension), co-packaged  
481  MYDRUG (drugozide oral solution; drugomycin nasal spray), co-packaged 
482   
483  If the co-packaged drug products have different routes of administration, the routes of 
484  administration should be listed in the same order in which the drug products appear within the 
485  parentheses, followed by the word respectively for clarity.  
486   
487  For example:   
488   
489  MYDRUG (drugozide injectable suspension; drugomycin tablets), co-packaged for 
490  intramuscular use and for oral use, respectively  
491   
492  For more complicated co-packaged drug products (e.g., those with more than three drug 
493  products), we encourage applicants to contact FDA review staff to determine the presentation of 
494  the product title. 
495   
496  For drug products for which the required diluent is enclosed in the package (e.g., a vial 
497  containing a lyophilized powder is packaged with a small vial of sterile water for injection to be 
498  used in the reconstitution of the powder), the name of the diluent generally should not be 
499  included in the product title. For purposes of this guidance, this is not considered a co-packaged 
500  drug product or an infusion solution (see section IV.E.1., Infusion Solutions). 
501   
502  3.  Lipid Complexes  
503   
504  Applicants should use the general format [drug] lipid complex type X [dosage form] when 
505  naming a lipid complex drug product. 
506   
507  Applicants should assume that the first lipid complex product approved for a particular drug and 
508  dosage form is type A, so the type should not be given (i.e., type A should not be included in 
509  the labeling). For subsequent drug products of the same drug and dosage form, applicants should 
510  list the type and replace X sequentially with B, C, D, . . . Z.  For generic drugs, the name and 
511  type designation should match the reference listed drug (RLD).  
512   
13 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation  
513  For example:   
514   
515  MYDRUG (drugozide lipid complex type B injection), for intravenous use  
516   
517  4.  Liposomes 
518   
519  Applicants should use the general format [drug] liposome type X [dosage form] or [drug] 
520  pegylated liposome type X [dosage form] when naming a liposomal drug product. 
521   
522  Applicants should assume that the first liposome product approved for a particular drug and 
523  dosage form is type A, so the type should not be given (i.e., type A should not be included in 
524  the labeling). For subsequent drug products of the same drug and dosage form, applicants should 
525  list the type and replace X sequentially with B, C, D, . . . Z.  For generic drugs, the name and 
526  type designation should match the RLD.  
527   
528  For example:   
529   
530  MYDRUG (drugozide liposome type C injection), for intravenous use 
531  MYDRUG (drugozide pegylated liposome injection), for intravenous use 
532   
533  5.  Radiopharmaceuticals 
534   
535  a.  General  format  
536   
537  Radiopharmaceuticals are composed of two parts, a pharmaceutical and a radionuclide (isotope).  
538  Applicants should use the general format [drug][isotope][route of administration][dosage 
539  form] when naming a radiopharmaceutical drug product.20  When the drug is a salt and both 
540  parts of the salt appear in the nonproprietary name (e.g., radium chloride), the isotope should 
541  immediately follow the name of the radioactive element. 
542    
543  For example:   
544   
545  MYDRUG (urea C 14 capsules), for oral use 
546  MYDRUG (fludeoxyglucose F 18) injection, for intravenous use 
547  MYDRUG (radium Ra 223 chloride) injection, for intravenous use 
548   
549  For radiopharmaceuticals that include a ligand, applicants should use the general nomenclature 
550  format of the radiolabeled product [drug][isotope][ligand][route of administration][dosage 
551  form].  
552   
553  For example:   
554   
555  MYDRUG (technetium Tc 99m oxidronate injection), for intravenous use  
                                                 
20 Because most radiopharmaceuticals are injections or capsules, the route of administration generally should not be  
included in the nonproprietary name.  The route of administration should follow the radiopharmaceutical name and 
should be presented as described  in section  IV.D.,  Route of  Administration.  
14 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation  
556   
557  For radiopharmaceuticals that are created using a kit that contains only a part of the active 
558  ingredient and/or for which the radionuclide is obtained from a separate source and added at the 
559  time of preparation, the name should be presented as kit for the preparation of [product 
560  nonproprietary name].  
561   
562  For example:   
563   
564  MYDRUG (kit for the preparation of technetium Tc 99m sestamibi injection), for 
565  intravenous use  
566   
567  For a radiopharmaceutical that is intended for ex-vivo radiolabeling with subsequent 
568  administration of the labeled drug product, the ultimate route of administration should not be 
569  included and should be described elsewhere in labeling.  Instead the phrase for radiolabeling 
570  should appear after the drug product name. 
571   
572  For example:   
573   
574  MYDRUG (indium In 111 oxyquinolone solution), for radiolabeling    
575   
576  b.  Radionuclide generator and associated drug product nomenclature 
577   
578  In many cases, a generator is used to produce the radionuclide that is subsequently used as a drug 
579  product or mixed with other components to produce a drug product.  In these cases, the product 
580  title should display a name  for both the generator and the final drug product and include the 
581  dosage form and route of administration.  The following formats should be used to create these 
582  different portions of the product title. 
583   
584     Generator Nomenclature:  When a generator is used to produce the radionuclide, 
585  applicants should use the general format [nuclide][isotope] generator.   
586   
587  For example:   
588   
589  MYDRUG (rubidium Rb 82 generator)  
590   
591     Generated Drug Product Nomenclature:  The name for the generator should be 
592  immediately followed by the phrase to produce and the name of the radionuclide that is 
593  produced. The salt should be included in this part of the product title when the eluting 
594  solution determines what salt is produced.  Applicants should use the general format to 
595  produce [drug][isotope]. If a salt is eluted, the placement of the cation or anion portion 
596  of the chemical name should follow standard nomenclature rules for chemical substances. 
597   
598  For example:   
599   
600  to produce rubidium Rb 82 chloride 
601  to produce sodium pertechnetate Tc99m 
15 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation  
602   
603     Dosage Form and Route of Administration:  The dosage form and route of administration 
604  should follow the name of the produced radionuclide and be presented as described 
605  earlier in sections IV.C., Dosage Form, and IV.D., Route of Administration. 
606   
607  In summary, the product title should be composed using the format PROPRIETARY NAME 
608  ([nuclide][isotope] generator) to produce [drug][isotope]. 
609   
610  For example:   
611   
612  MYDRUG (rubidium Rb 82 generator) to produce rubidium Rb 82 chloride injection, 
613  for intravenous use 
614  MYDRUG (technetium Tc 99m generator) to produce sodium pertechnetate Tc99m 
615  injection, for intravenous use   
616   
617  F.  Controlled Substance Symbol 
618   
619  If the DEA issues an interim final rule assigning a controlled substance schedule, the controlled 
620  substance symbol must be included in the product title (21 CFR 201.57(a)(2)).  The controlled 
621  substance symbol should appear at the end of the product title and be preceded by a comma.  The 
622  symbol should be written as C followed by the Roman numeral designating the schedule.  As 
623  described in 21 CFR 1302.03(c), the Roman numeral may immediately follow C or may be 
624  preceded by a hyphen (e.g., CIII or C-III).  
625   
626  For example:   
627   
628  MYDRUG (drugozide) extended-release tablets, for oral use, CIV  
629  MYDRUG (drugozide) injection, for intravenous use, C-II  
630   
631  If scheduling of the controlled substance is pending when the application is approved under 
632  section 505(c) of the FD&C Act or section 351(a) of the PHS Act, the product title should reflect 
633  the pending status of the scheduling action.   
634   
635  For example: 
636   
637  MYDRUG (drugozide) oral solution, [controlled substance schedule pending] 
638   
639  The product title must be updated with the controlled substance symbol after the DEA issues an 
640  interim final rule controlling the drug (21 CFR 201.57(a)(2)).21  
641   
642   
                                                 
21  When the DEA issues an interim final rule controlling  the drug, a supplement  must be submitted to reflect the 
schedule (21 CFR 314.70 and 21 CFR 601.12(f)). 
16 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation  
643  V.  ITEMS THAT SHOULD NOT BE INCLUDED IN THE PRODUCT TITLE 
644   
645  In the interest of consistency, the FDA discourages the following content and/or formatting from 
646  being included in the product title in Highlights: 
647   
648     Drug product origin (e.g., synthetic, natural, or rDNA) unless it is required by regulation, 
649  it is part of the established name or proper name, or it is clinically relevant for the 
650  prescriber (e.g., human).22  (Important information on drug product origin can appear 
651  elsewhere in labeling (e.g., in the DESCRIPTION section).)  
652   
653     Slash (/) marks when displaying the name of combination products (see section IV.B.2., 
654  Fixed-Combination Drug Products). 
655   
656     Additional descriptors (e.g., single-dose vial or film-coated).  
657   
658     Methods of intravenous administration (e.g., infusion, bolus, or push) (see section 
659  IV.D.4., Intravenous Methods). 
660   
661     Dosage strength (e.g., drugozide ointment, 0.05%) (see section IV.A., Basic Format) 
662  (exceptions may be appropriate (e.g., for intravenous immunoglobulins or albumin 
663  biological products that are available in multiple strengths)).  
664   
665     Inactive ingredients or lack thereof (e.g., alcohol-free).  
666   
667     Abbreviations (e.g., IV for intravenous or HCl for hydrochloride) (see section IV.A., 
668  Basic Format).  
669   
670     Embedded graphics (see section IV.F., Controlled Substance Symbol). 
671   
672     Storage conditions (e.g., room  temperature or frozen).  
673   
674  The following words should not be used in the product title in Highlights: 
675   
676     USP as part of the nonproprietary name in the product title in Highlights (as distinct 
677  from use on container or carton labeling)  
678   
679     Concentrate for drug products requiring dilution before administration (see 
680  Appendix A)23   
681   
                                                 
22 For example, 21 CFR 640.80 requires the inclusion  of the word human for albumin biological products. 
 
23 There are a few historical exceptions.  For example, USP retains concentrate in Potassium Chloride for Injection  
Concentrate and several other legacy  drug products for various  reasons.  
17 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation  
682     Powder as a dosage form for drug products requiring reconstitution before 
683  administration (see section IV.C.4., Drug Products Requiring Reconstitution, section 
684  IV.C.5., Injectable Drug Products, and Appendix A)  
685   
686     Solution as a dosage form for injectable drug products (see Appendix A) 
687   
688     Drops as a dosage form for ophthalmic or otic suspensions and solutions (see 
689  Appendix A) 
690   
691     Kit (except when the marketed drug product does not contain the active ingredient (see 
692  section IV.E.5., Radiopharmaceuticals, and Appendix A)) 
693   
694     Only (e.g., for topical use only) (see section IV.D.1., General Format) 
695   
696   
697  VI.  PRODUCT TITLE AND IMPLICATIONS FOR CONTAINER AND CARTON  
698  LABELING 
699   
700  The drug product information in the product title and on the container and carton labeling should 
701  be as consistent as possible. We acknowledge the following differences that may exist between 
702  the product title in Highlights and the container and carton labeling: 
703   
704     The proprietary name in the product title in Highlights should be presented in uppercase 
705  letters even if the proprietary name on the container and carton labeling is presented in a 
706  different manner. 
707   
708     The placement of the elements of the product title (e.g., controlled substance symbol) 
709  may occasionally vary between the container and carton labeling and the product title in 
710  Highlights. 
711   
712     Although all elements of a product title in Highlights should be presented on one line as 
713  space permits, dosage form and route of administration information can be presented 
714  beneath the drug or biological product name on container and carton labeling.      
715   
716     Abbreviations for salts (e.g., HCl for hydrochloride) are appropriate for use on container 
717  and carton labeling provided their use is consistent with USPs labeling requirements.24  
718   
719     Generally, the strength of the drug product does not appear in the product title in 
720  Highlights, but appears elsewhere in the prescribing information and on container and 
721  carton labeling.25   
722   
                                                 
24 See USP General Chapter <7> Labeling for additional information on  labeling of  drug products.   
 
25 For example, see 21 CFR 201.57(a)(8), 21  CFR 201.57(c)(4),  21 CFR 201.100(b)(4), 21 CFR 610.60, and 
21 CFR  610.61.  
18 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation  
723     Route of administration information may differ between the container and carton labeling 
724  and the product title in Highlights.  For example: 
725   
726    When important for patient safety, the word only may appear with the route of 
727  administration (e.g., For topical use only) on the container and carton labeling, and 
728  elsewhere in the prescribing information, but should not be in the product title.   
729   
730    Methods of intravenous administration (e.g., intravenous infusion) may be on the 
731  container and carton labeling, but such terms should not be in the product title. 
732   
733   
734  VII.  INITIAL U.S. APPROVAL 
735   
736  On the line immediately beneath the product title, the verbatim statement Initial U.S. 
737  Approval must be displayed, followed by a colon and the four-digit year in which the FDA 
738  initially approved the new molecular entity (NME),26 the new biological product,27 or the new 
739  combination of active ingredients (21 CFR 201.57(a)(3)).  The statement must be in bold print 
740  (21 CFR 201.57(d)(5)).  Applicants should not list multiple years or add footnotes in Highlights 
741  regarding the year of initial U.S. approval. Applicants should consider the following items when 
742  identifying the year of the initial U.S. approval in draft labeling and should contact the FDA if 
743  other concerns arise.  
744   
745  A.  Active Moiety   
746   
747  For a drug product that is not a biological product and that contains only a single active moiety  
748  (see the Glossary), the initial U.S. approval is the year in which the first drug product containing 
749  that active moiety was approved, regardless of dosage form.  
750   
751  For example:    
752   
753  If the active moiety drugozide was originally approved as the NME drugozide hydrochloride, 
754  any subsequent product containing drugozide (e.g., drugozide hydrobromide or drugozide as 
755  a free base) should use the year of approval of drugozide hydrochloride when selecting the 
756  year of initial U.S. approval. 
757   
758  B.   Multiple Dosage Forms  
759   
760  Multiple years should not be listed for drug products with multiple dosage forms approved in 
761  different years. The initial U.S. approval should be the year of first approval of the NME, new 
762  biological product, or new combination of active ingredients regardless of dosage form, even if 
                                                 
26 In some cases, a prodrug may be considered an NME.  Applicants should  contact the FDA to determine if a 
prodrug meets the criteria to  be considered an  NME for the purposes of selecting the year of initial U.S. approval.  
 
27 For biosimilar products, see the draft guidance for industry Labeling for Biosimilar Products.  When final, this 
guidance will represent the FDAs current thinking  on this topic. 
19 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation  
763  the labeling does not refer to the older formulation(s).  Differences in indications or dosing do 
764  not affect the year of initial U.S. approval. 
765     
766  C.  Fixed-Combination Drug Products and Co-Packaged Drug Products 
767   
768  For fixed-combination drug products, the novelty of the combination is the determining factor 
769  for the initial U.S. approval. For example, if a fixed-combination drug product contains 
770  components that have each been previously approved individually, then the initial U.S. approval 
771  should be the year of the approval of the combination.  Likewise, if a fixed-combination drug 
772  product contains at least one component that has not previously been approved, then the initial 
773  U.S. approval should be the year of the approval of the combination, regardless of the date of 
774  approval of other previously approved components.  The same approach applies to co-packaged 
775  drug products. 
776   
777  D.  Controlled Substances 
778   
779  In the case of an NME, new biological product, or new combination of active ingredients for 
780  which the Department of Health and Human Services recommends controls under the Controlled 
781  Substances Act, the year of initial U.S. approval comes from the date of approval determined 
782  under section 505(x) of the FD&C Act for new drug applications (NDAs) and under section 
783  351(n) of the PHS Act for 351(a) biologics license applications (BLAs).28   
784    
785  If scheduling of the controlled substance is pending when the application is approved under 
786  section 505(c) of the FD&C Act or section 351(a) of the PHS Act, the initial U.S. approval in the 
787  Highlights should reflect the pending status of the scheduling action. 
788   
789  For example: 
790   
791  Initial U.S. Approval: [pending controlled substance scheduling] 
792   
793  Highlights must be updated with the year of initial U.S. approval corresponding to the year in 
794  which the DEA issues an interim final rule controlling the drug (21 CFR 201.57(a)(3)).29  
795   
796  E.  Racemates  
797   
798  If a drug product is to be approved containing only one enantiomer of an already approved 
799  racemate drug product, the year for the new drug product should be that of the racemate because 
800  the individual enantiomer has already been approved as part of the racemate.  The nonproprietary  
801  name of the originally approved racemate can be included in parentheses. 
802   
                                                 
28  For affected applications approved after  November 25, 2015 (the  date that these subsections were added to the 
respective statutory provisions), the date of  approval is the later of:  (1) the date the application is approved;  or (2) 
the date that the DEA issues an interim final rule controlling the drug.  For applications approved  before November 
25, 2015, the date of approval is the date of the FDA approval letter for the NDA or  BLA.   
 
29  When the DEA issues an interim final rule controlling the drug, a supplement  must be submitted to reflect the year 
of initial U.S. approval (21 CFR 314.70 and  21 CFR 601.12(f)). 
20 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation  
803  For example:   
804   
805  If the drug product MYDRUG (esdrugozide) capsules is approved any time after the racemic 
806  mixture drug products approval in 1998, the line should read, Initial U.S. Approval: 1998 
807  (drugozide). 
808   
809  Additional information identifying the drug product components can be included in the 
810  DESCRIPTION section of the prescribing information.   
811   
812  F.   Drug Efficacy Study Implementation Drugs  
813   
814  For a drug efficacy study implementation (DESI) drug, the initial U.S. approval should be the 
815  year of the original approval of the NME, not the year of the postapproval DESI update.   
816   
817  G.  Approval of Previous Marketed Unapproved Drugs  
818   
819  For marketed unapproved drugs for which an NDA is later submitted and approved, the initial 
820  U.S. approval should be the year of the first NDA approval for the new molecular entity, new 
821  biological product, or new combination of active ingredients.30  For marketed unapproved 
822  fixed-combination drug products, see section VII.C., Fixed-Combination Drug Products and Co-
823  Packaged Drug Products. 
824   
825  H.  Previously Approved Drug Product Reintroduced Into Market  
826   
827  When a previously approved drug product is removed from the market for any reason and 
828  subsequently reintroduced, the initial U.S. approval should be the year of the original approval of 
829  the new molecular entity, new biological product, or new combination of active ingredients.31   
830  For previously approved fixed-combination drug products, see section VII.C., Fixed-
831  Combination Drug Products and Co-Packaged Drug Products   
832   
833   
                                                 
30 See 21 CFR 201.56(a)(3). 
 
31 See id.  
21 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation  
834  GLOSSARY 
835   
836  Active ingredient:  An active ingredient is any component that is intended to furnish 
837  pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or 
838  prevention of disease, or to affect the structure or any function of the body of man or other 
839  animals.  The term includes those components that may undergo chemical change in the 
840  manufacture of the drug product and be present in the drug product in a modified form intended 
841  to furnish the specified activity or effect.32  
842   
843  Active moiety:  Active moiety is the molecule or ion, excluding those appended portions of the 
844  molecule that cause the drug to be an ester, salt (including a salt with hydrogen or coordination 
845  bonds), or other noncovalent derivative (such as a complex, chelate, or clathrate) of the 
846  molecule, responsible for the physiological or pharmacological action of the drug substance.33    
847   
848  Biological product:  A biological product is a virus, therapeutic serum, toxin, antitoxin, 
849  vaccine, blood, blood component or derivative, allergenic product, protein (except any  
850  chemically synthesized polypeptide) or analogous product, or arsphenamine or derivative of 
851  arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, 
852  treatment, or cure of a disease or condition of human beings.34    
853   
854  Established name:35  As defined in the FD&C Act, the term established name, with respect to 
855  a drug or ingredient thereof, means (A) the applicable official name designated pursuant to 
856  section 508, or (B) if there is no such name and such drug, or such ingredient, is an article 
857  recognized in an official compendium [see definition below], then the official title thereof in 
858  such compendium, or (C) if neither clause (A) or clause (B) of this subparagraph applies, then 
859  the common or usual name, if any of such drug or such ingredient, except that where clause (B) 
860  of this subparagraph applies to an article recognized in the United States Pharmacopeia and in 
861  the Homeopathic Pharmacopoeia under different official titles, the official title used in the 
862  United States Pharmacopeia shall apply unless it is labeled and offered for sale as a homeopathic 
863  drug, in which case the official title used in the Homeopathic Pharmacopoeia shall apply.36   
864   
865  New molecular entity:  A new molecular entity is an active ingredient that contains no active 
866  moiety that has been previously approved by the FDA in an application submitted under section 
867  505 of the FD&C Act or has been previously marketed as a drug in the United States. 
868   
869  Nonproprietary name:  A name unprotected by trademark rights that is in the public domain.  It 
870  may be used by the public at large, both lay and professional.   
                                                 
32 See 21 CFR 314.3(b). 
 
33 See 21 CFR 314.3(b). 
 
34 See section  351(i)(1) of the PHS Act. 
 
35 The nonproprietary name used in the product title for nonbiological drug  products is the established name.   
 
36 See section 502(e)(3) of the FD&C Act. 
 
22 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation  
871   
872  Official compendium:  Official compendium is defined in the FD&C Act as the official United 
873  States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, official 
874  National Formulary, or any supplement to any of them.37  
875   
876  Product title:  The product title of a drug product consists of the drug names, dosage form, route 
877  of administration, and controlled substance symbol (if applicable).38      
878   
879  Proper name:  For biological products, the proper name means the name designated in the 
880  license for use upon each package of the product.39  
881   
882  Proprietary name:  The exclusive name of a drug product owned by a company under 
883  trademark law regardless of registration status with the Patent and Trademark Office. 
884   
                                                 
37 See section 201(j) of the FD&C Act. 

 
38 See 21 CFR 201.57(a)(2).  

 
39 See 21 CFR 600.3(k); the nonproprietary name used in the product title for biological products is the proper name. 

23 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation  
885  APPENDIX A:   
886  DOSAGE FORM TERMS FOR USE IN HUMAN DRUG PRODUCT LABELING 
887   
888  The following list of dosage forms has been created to assist the reader in selecting the proper 
889  dosage form terminology for use in the nomenclature of human drug products.     
890   
891  The basic dosage form terms appear along the left margin.  Examples of how the basic dosage 
892  form terms are used when combined with other modifiers and/or routes of administration are 
893  provided as indented text. 
894   
895     A bolded and underlined term means both the FDA and the United States Pharmacopeia 
896  (USP) recommend use of the term   
897   
898     A bolded term means the FDA recommends use of the term   
899   
900     An underlined term means USP recommends use of the term    
901   
902     A term neither bolded nor underlined means the term is a nonpreferred term 
903   
904     Italicized examples are the subject of discussion between the FDA and USP 
905   
906  Dosage form terms that appear only in bolded or underlined print are being discussed by the 
907  FDA and USP and represent terminology that may be changed at a later date.  If the term is 
908  neither bolded nor underlined, then the term is a nonpreferred term and the reader is directed to 
909  preferred terminology.  In some cases, USP monographs using nonpreferred terms still exist.  
910  However, these older, noncompliant terms found in monographs should not be cited as a 
911  precedent for future use of the dosage form terms.   
912   
913  Indented beneath the basic dosage form term is a list of examples of how the dosage form term  
914  has been used in the nomenclature of drug products.  Although an attempt has been made to 
915  make a complete list of all currently used route of administration/dosage form formats, it is 
916  recognized that new formats are created as new dosage forms or drug products with new routes 
917  of administration are developed.  These examples often demonstrate how a route of 
918  administration is (or is not) used in association with the dosage form when creating a drug 
919  product nonproprietary name.  There are also examples in which the dosage form includes an 
920  additional term that specifies that the release of the drug product has been modified.   
921   
922  The use of the word for before a dosage form term is used to describe a solid dosage form  
923  (e.g., lyophilized powder or granules) that requires reconstitution before administration.  The 
924  plural noun of the dosage form (e.g., lozenges) should be used unless the drug product is 
925  supplied only as a single unit (e.g., intravitreal insert). 
926   
927  If an applicant determines that a format different from any of the examples is appropriate, the 
928  FDA encourages the applicant to initiate discussions with the FDA as soon as possible.    
929   
24 
 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation  
930  For biological products, applicants are encouraged to initiate discussions with the FDA on 
931  selection of dosage form terminology. 
25 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation  
932  Terminology 
933   
934  Aerosol   
935  Aerosols are packaged under pressure. All aerosols are assumed to be metered except topical 
936  aerosols. Topical aerosols are assumed not to be metered unless labeling indicates they are 
937  metered. 
938   
939  inhalation aerosol  assumed to be for oral inhalation 
940  lingual aerosol 
941  nasal aerosol 
942  topical aerosol  
943   
944  Bead  not preferred, see Pellet 
945   
946  Caplet  not preferred, see Tablet  
947   
948  Capsule   
949  Capsules are assumed to be oral. 
950  Note: In the past, the terminology vaginal capsules was used, but these drug products are 
951  now referred to as vaginal inserts. 
952   
953  capsules  
954  delayed-release capsules 
955  extended-release capsules 
956   
957  Collodion  not preferred, see Solution  
958  Note: Collodion is reserved for pyroxilin in alcohol and ether. 
959   
960  Concentrate  not preferred term for human drug products, see the appropriate dosage form  
961  (e.g., Solution or Suspension) 
962  Note: USP General Chapter <1121> Nomenclature refers to the USP Nomenclature 
963  Guidelines that currently restrict the use of concentrate to drug substances that are not 
964  intended for direct administration.   
965   
966  Cream   
967  A cream is a semisolid emulsion dosage form.  It is assumed to be topical unless otherwise 
968  specified.  
969   
970  cream   
971  vaginal cream 
972   
973  Drop  not preferred, see the appropriate dosage form (e.g., Solution or Suspension) 
974   
975  Elixir  not preferred, see Solution 
976   
26 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation  
977  Emulsion   
978  Emulsion is used as a dosage form term only when a more specific term (e.g., cream, lotion, 
979  ointment) is not applicable. 
980     
981  ophthalmic emulsion 
982  oral emulsion 
983  topical emulsion  not preferred, see Lotion 
984  see also Injection for injectable emulsion  
985   
986  Film   
987  A film is a thin sheet of material.   
988     
989  buccal film  
990  oral film  
991  sublingual film     
992   
993  Foam   
994   
995  topical foam 
996  see also Injection for injectable foam 
997   
998  Gas   
999  The name of the specific gas should be used without the use of the term gas. 
1000   
1001  medical air 
1002  oxygen 
1003   
1004  Gel     
1005   
1006  dental gel 
1007  nasal gel 
1008  ophthalmic gel 
1009  oral gel 
1010  periodontal gel 
1011  topical gel 
1012  vaginal gel 
1013   
1014  Gels  
1015   
1016  chewable gels  
1017   
1018  Granule   
1019  This term should be used when the drug product is administered as granules.  For granules 
1020  that are reconstituted to make the administered dosage form, the word for should be 
1021  inserted in front of the route of administration and dosage form.  For example: In the case of 
27 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation  
1022  granules that are reconstituted to make an oral solution, the appropriate nomenclature would 
1023  be [DRUG] for oral solution. 
1024   
1025  oral granules 
1026   
1027  Gum  
1028   
1029  Gum 
1030   
1031  Implant   
1032  Implants are inserted into the body often using a special injector or by surgical incision.  As 
1033  with injections, the specific route of administration typically is not included in the 
1034  nonproprietary name unless there is only a single anatomical location for the implant. 
1035   
1036  implant(s)   
1037  intravitreal implant     
1038   
1039  Inhalant  
1040  The FDA and USP need to have further discussion regarding this dosage form. 
1041   
1042    inhalant(s)  
1043   
1044  Inhalation  not preferred, see the appropriate dosage form (e.g., Solution or Suspension) 
1045  Health care providers often use the term inhalation as a dosage form  when it is actually a 
1046  method of administration.  Inhaled drug products are administered orally with the use of a 
1047  nebulization system or an external nebulizer.  Sterile water for inhalation is the only drug 
1048  product that uses inhalation as the dosage form. 
1049   
1050  Injection   
1051  For injections, the route should not be included in the nonproprietary name.  The specific 
1052  route of administration (e.g., intramuscular, subcutaneous) appears elsewhere.  
1053   
1054  injection  
1055  for injection  
1056  extended-release injection 
1057  injectable emulsion 
1058  injectable foam 
1059  injectable suspension  
1060  for injectable suspension  
1061  extended-release injectable suspension (The USP Nomenclature, Safety and Labeling 
1062  Expert Committee voted to adopt this terminology, but the terminology has not yet 
1063  become official in the United States Pharmacopeia-National Formulary (USP-NF).) 
1064  for extended-release injectable suspension (The USP Nomenclature, Safety and Labeling 
1065  Expert Committee voted to adopt this terminology, but the terminology has not yet 
1066  become official in the USP-NF.) 
28 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation  
1067  for injection concentrate (Currently reserved for potassium chloride for injection 
1068  concentrate. This terminology is restricted for use with only this drug product by the 
1069  USP Nomenclature Guidelines that are referenced in General Chapter <1121>.  
1070  Therefore, it may not be used for another drug product unless the FDA and USP agree 
1071  its use is appropriate.) 
1072  see also Lipid Complex and Liposome 
1073   
1074  Drug products for infusion have monograph titles based on the following general format:  
1075   
1076  [drug] in [vehicle] injection 
1077   
1078  Specific examples of formats that currently appear in the USP are shown below.  The 
1079  concentration of the vehicle(s) named in the official title is/are stated as  if part of the official 
1080  title (e.g., dextrose injection 5%, or dextrose (5%) and sodium chloride (0.2%) injection) 
1081  on the container label and carton labeling, but not on the product title line.   
1082   
1083  in dextrose injection 
1084  in dextrose and sodium chloride injection  
1085  in lactated ringers and dextrose injection 
1086  in sodium chloride injection  
1087   
1088  Insert   
1089  Note: Inserts are inserted into a naturally occurring body cavity other than the mouth or 
1090  rectum.  See Suppository for drug products inserted into the rectum. 
1091   
1092  urethral inserts 
1093  vaginal inserts 
1094     
1095  Irrigation 
1096  Irrigation is a sterile solution intended to bathe or flush open wounds or body cavities.  
1097  Irrigations are used to rinse body surfaces other than the mouth.  There is a need to carefully 
1098  differentiate among related terms (e.g., irrigation, rinse, and solution).  The route of 
1099  administration typically is not included in the nonproprietary name unless there is a highly 
1100  specific route.  
1101   
1102  irrigation 
1103  for irrigation  
1104  intraocular irrigation  
1105   
1106  Jelly  not preferred, see Gel 
1107   
1108  Kit  not a dosage form   
1109   
29 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation  
1110  Lipid Complex 
1111  A lipid complex is not a dosage form.  However, it has been included in this list to assist the 
1112  user in developing proper nomenclature for drug products that are lipid complexes.  The 
1113  general nomenclature format is: 
1114   
1115  [drug] lipid complex type X [dosage form] 
1116   
1117  The drug name and dosage form replace the brackets.  Applicants should assume that the first 
1118  lipid complex product approved for a particular drug and dosage form is type A, so the type 
1119  should not be given (i.e., type A should not be included in the labeling).  For subsequent 
1120  drug products of the same drug and dosage form, applicants should list the type and replace 
1121  X sequentially with B, C, D, . . . Z. 
1122   
1123  Liposome   
1124  A liposome is not a dosage form.  However, it has been included in this list to assist the user 
1125  in developing proper nomenclature for liposomal drug products.  The general nomenclature 
1126  format is: 
1127   
1128  [drug] liposome type X [dosage form]   
1129   
1130  Or  
1131     
1132  [drug] pegylated liposome type X [dosage form] 
1133   
1134  The drug name and dosage form replace the brackets.  Applicants should assume that the first 
1135  liposome product approved for a particular drug and dosage form is type A, so the type 
1136  should not be given (i.e., type A should not be included in the labeling).  For subsequent 
1137  drug products of the same drug and dosage form, applicants should list the type and replace 
1138  X sequentially with B, C, D, . . . Z. 
1139   
1140  Liquid 
1141  A liquid is a dosage form consisting of a pure chemical in its liquid state.  This dosage form  
1142  should not be applied to solutions. Typically, the term liquid is not used in drug product 
1143  nonproprietary names.  Rare exceptions may be permitted (e.g., oral liquid). 
1144   
1145  Lotion   
1146  A lotion is an emulsion, liquid dosage form.  It is assumed to be topical. 
1147   
1148  lotion 
1149   
1150  Lozenge  
1151  A lozenge is assumed to be oral.   
1152   
1153  lozenges 
1154   
1155  Mouthwash  not preferred, see Rinse  
30 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation  
1156   
1157  Ointment   
1158  An ointment is assumed to be topical unless otherwise specified.  If multiple routes are 
1159  approved (e.g., topical and rectal), no route is associated with the dosage form term (e.g., 
1160  ointment).  The route should be included only if it is the sole approved nontopical route (e.g., 
1161  ophthalmic ointment). 
1162   
1163  ointment 
1164  nasal ointment 
1165  ophthalmic ointment 
1166   
1167  Paste   
1168  A paste is assumed to be topical unless otherwise specified.  
1169   
1170  paste 
1171  dental  paste 
1172  oral paste 
1173   
1174  Patch  not preferred for use in nonbiologic drug product nomenclature, see System    
1175  Note: This term has been used historically for allergen patch test products.  
1176   
1177  Pellet  
1178  See also Implant; many pelletized dosage forms are implants.  The FDA and USP need to 
1179  have further discussion concerning this dosage form. 
1180     
1181  pellets   
1182  oral pellets 
1183   
1184  Pill  not preferred, see Tablet or Capsule  
1185  Note: Pill is reserved for a solid, spherical dosage form usually prepared by a wet massing, 
1186  piping, and molding technique. 
1187   
1188  Plaster  not preferred  
1189   
1190  Pledget  not preferred, see Swab 
1191     
1192  Powder   
1193  This term is used when the drug product is administered as a powder.  For a powder that is 
1194  reconstituted to make the administered dosage form, the word for should be inserted in 
1195  front of the route of administration and dosage form.  For example: In the case of a powder 
1196  that is reconstituted to make an oral solution, the appropriate terminology would be 
1197  [DRUG] for oral solution. 
1198   
1199  inhalation powder  assumed to be for oral inhalation 
1200  nasal powder  used topically in the nose  
1201  nasal inhalation powder  used for powder inhaled through the nose 
31 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation  
1202  oral powder 
1203  topical powder 
1204     
1205  Rinse   
1206  This term is reserved for drug products that are used to rinse the mouth, then expectorated.  
1207  Use Irrigation for other routes of administration when the solution is used for rinsing. 
1208   
1209  rinse 
1210   
1211  Shampoo   
1212  A shampoo is assumed to be topical. 
1213   
1214  shampoo  
1215   
1216  Soap 
1217  A soap is assumed to be topical. 
1218   
1219    soap 
1220   
1221  Solution  
1222   
1223  inhalation solution 
1224  for inhalation solution  a powder that is reconstituted to make an inhalation solution 
1225  intraocular solution  
1226  intravesical solution  
1227  nasal solution  for local application to the nasal passages.  A nasal solution will be 
1228  assumed not to be metered unless labeling indicates that it is  metered.  
1229  ophthalmic solution  
1230  for ophthalmic solution 
1231  oral solution 
1232  for oral solution  
1233  for effervescent oral solution  
1234  otic solution  
1235  for otic solution 
1236  rectal solution 
1237  solution  may appear without a route in unique circumstances such as when the 
1238  solution is either: (1) for ex-vivo use (e.g., to radiolabel blood cells that subsequently 
1239  will be readministered to a patient); or (2) labeled for both oral and rectal  
1240  administration, where it would be misleading as either oral solution or rectal 
1241  solution.40    
1242  solution for inhalation  a solution that has to be diluted before it is administered  
1243  topical solution 
1244  for topical solution  
                                                 
40 The FDA text  differs from the USP text  because the USP text also addresses the development of titles for 
disinfectants  that  are not regulated as drug products.  
32 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation  
1245  see also Injection, Inhalation, Irrigation, Rinse, Shampoo, Soap, and 
1246  Spray 
1247   
1248  Spirit  not preferred, see Solution 
1249   
1250  Spray   
1251  Sprays are nonpressurized dosage forms.  All sprays are assumed to be metered except the 
1252  topical sprays. Topical sprays are assumed not to be metered unless labeling indicates they 
1253  are metered.  
1254   
1255  inhalation spray  assumed to be for oral inhalation 
1256  lingual spray  
1257  nasal spray  
1258  oral spray 
1259  topical spray 
1260     
1261  Strip  used only for diagnostic drug products, otherwise not preferred, see Film  
1262   
1263  Suppository   
1264  This term is reserved for drug products inserted into the rectum.  See Insert for drug 
1265  products inserted into other body cavities. 
1266   
1267  suppositories 
1268   
1269  Suspension 
1270   
1271  inhalation suspension 
1272  ophthalmic suspension 
1273  for ophthalmic suspension 
1274  oral suspension 
1275  delayed-release oral suspension  
1276  extended-release oral suspension  
1277  for oral suspension  
1278  for delayed-release oral suspension 
1279  for extended-release oral suspension  
1280  otic suspension 
1281  for otic suspension  
1282  rectal suspension  
1283  suspension  may appear without a route in unique circumstances such as when the 
1284  suspension is either: (1) for ex-vivo use (e.g., to radiolabel blood cells that 
1285  subsequently will be readministered to a patient); or (2) labeled for both oral and 
1286  rectal administration, where it would be misleading as either oral suspension or rectal 
1287  suspension.41  
1288  suspension for inhalation  a suspension that has to be diluted before it is administered 
                                                 
41 The FDA text  differs from the USP text  because the USP text also addresses the development of titles for 
disinfectants  that  are not regulated as drug products.  
33 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation  
1289  topical suspension  
1290  for topical suspension 
1291  see also Injection, Inhalation, Irrigation, Rinse, Shampoo, Soap, and 
1292  Spray 
1293   
1294  Swab  
1295  A swab is assumed to be topical unless otherwise specified.  The FDA and USP need to have 
1296  further discussion regarding this dosage form. 
1297   
1298  swabs 
1299   
1300  Syrup  not preferred, see Solution or Suspension 
1301     
1302  System  
1303  This term is used for a drug-containing delivery system that controls the release rate of the 
1304  drug product from the system by diffusion kinetics, active transport, or other means.  The 
1305  activity is defined in terms of the release rate of the active ingredient(s) from the system over 
1306  a stated period of time.  The rate of release and the total duration of drug release typically 
1307  appear on the drug product and on the container label and carton labeling, but not on the 
1308  product title line. 
1309   
1310  intrauterine systems  
1311  ocular systems  
1312  oral mucosal systems 
1313  periodontal systems 
1314  topical systems  
1315  transdermal systems 
1316  iontophoretic transdermal systems 
1317  vaginal systems  
1318     
1319  Tablet    
1320  Note: In the past, the terminology vaginal tablets was used, but these drug products are 
1321  now referred to as vaginal inserts. 
1322   
1323  tablets  
1324  buccal tablets 
1325  chewable tablets  only if the tablet MUST ALWAYS be chewed; if it MAY be 
1326  chewed, use tablets 
1327  delayed-release tablets  
1328  extended-release tablets  
1329  orally disintegrating tablets 
1330  delayed-release orally disintegrating tablets 
1331  sublingual tablets 
1332  tablets for oral solution  
1333  effervescent tablets for oral solution  A special type of tablet that is intended to be 
1334  dissolved in water before administration.  It contains mixtures of acids (e.g., citric 
34 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation  
1335  acid, tartaric acid) and carbonates and/or hydrogen carbonates, and upon contact with 
1336  water it releases carbon dioxide. 
1337  tablets for topical solution    
1338  tablets for oral suspension  
1339   
1340  Tape  not preferred 
1341   
1342  Tincture  not preferred, see Solution 
1343   
1344  Troche  not preferred, see Lozenge 
1345   
35 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation  
1346  APPENDIX B: 
1347  ROUTE OF ADMINISTRATION TERMS FOR USE IN THE PRODUCT TITLE  
1348   
1349  The following table lists the most commonly used route of administration terms for use in the 
1350  product title. This list is derived from the FDA Data Standards Manual Route of Administration 
1351  list with minor differences made to create a list that is appropriate for use in the product title.  If 
1352  an applicant determines that a route of administration term different from any of the examples is 
1353  appropriate, the applicant is encouraged to initiate discussions with the FDA.  
1354   
Name  Definition 
Buccal  Administration directed toward the cheek, generally 
from within the mouth 
Dental  Administration to a tooth or teeth  
Endocervical  Administration within the canal of the cervix uteri  
Endotracheal  Administration directly into the trachea 
Enteral  Administration directly into the intestines  
Epidural  Administration on or over the dura mater 
Extracorporeal  Administration outside of the body 
   
(For certain radiopharmaceuticals, it   
may be appropriate to use the phrase 
for radiolabeling instead of the 
route of administration 
extracorporeal. 
Hemodialysis  Administration through hemodialysate fluid 
Infiltration  Administration that results in substances passing 
into tissue spaces or into cells  
Inhalation   Administration within the respiratory tract by 
inhaling orally and nasally for local or systemic 
effect 
 
(For purposes of the product title, this term is 
reserved for drug products that can be administered 
both orally and nasally (see also ORAL 
INHALATION and NASAL INHALATION).) 
Interstitial   Administration to or in the interstices of a tissue  
Intra-abdominal  Administration within the abdomen 
1355  continued 
36   Contains Nonbinding Recommendations 
Draft  Not for Implementation  
1356  continued 
Name  Definition 
Intra-amniotic   Administration within the amnion 
Intra-arterial   Administration within an artery or arteries  
Intra-articular   Administration within a joint 
Intrabiliary   Administration within the bile, bile ducts, or 
gallbladder  
Intrabronchial  Administration within a bronchus 
Intrabursal  Administration within a bursa 
Intracardiac   Administration within the heart 
Intracaudal  Administration within the cauda equina 
Intracavernous  Administration within a pathologic cavity, such as 
occurs in the lung in tuberculosis 
Intracorneal  Administration within the cornea (the transparent 
structure forming the anterior part of the fibrous 
tunic of the eye) 
Intradermal  Administration within the dermis 
Intradiscal  Administration within a disc  
Intraductal  Administration within the duct of a gland  
Intragingival  Administration within the gingivae 
Intralesional  Administration within or introduced directly into a 
localized lesion 
Intramuscular   Administration within a muscle  
Intraocular   Administration within the eye  
Intrapericardial  Administration within the pericardium  
Intraperitoneal  Administration within the peritoneal cavity  
Intrapleural  Administration within the pleura  
Intrasynovial  Administration within the synovial cavity of a joint 
Intratesticular   Administration within the testicle  
1357  continued 
37 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation  
1358  continued 
Name  Definition 
Intratympanic  Administration within the auris media 
Intrauterine   Administration within the uterus  
Intravenous  Administration within or into a vein or veins 
Intravesical  Administration within the bladder  
Intravitreal  Administration within the vitreous body of the eye 
Nasal  Administration to the nose; administered by way of 
the nose 
Nasal inhalation  Administration by way of the nose for local or 
systemic effect (see INHALATION) 
Ophthalmic  Administration to the external eye 
Oral  Administration to or by way of the mouth 
Oral inhalation  Administration by way of the mouth and intended 
for delivery to the respiratory tract for local or 
systemic effect (see INHALATION) 
Oropharyngeal  Administration directly to the mouth and pharynx 
Otic  Administration to or by way of the ear 
Periodontal  Administration around a tooth 
Rectal  Administration to the rectum 
Retrobulbar  Administration behind the pons or behind the 
eyeball 
Soft tissue  Administration into any soft tissue 
Subarachnoid  Administration beneath the arachnoid 
Subconjunctival  Administration beneath the conjunctiva 
Subcutaneous  Administration beneath the skin; hypodermic  
Sublingual  Administration beneath the tongue 
Topical  Administration on the outer surface of the body  
 
(For purposes of the product title, this term applies 
to products with either local or systemic effect.) 
1359  continued 
38 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation  
1360  continued 
Name  Definition 
Transdermal   Administration through the dermal layer of the skin 
to the systemic circulation by diffusion  
 
(For purposes of the product title, this term applies 
to delivery systems that are applied to the skin.)  
Transmucosal  Administration across the mucosa 
Transtracheal  Administration through the wall of the trachea 
Urethral  Administration into the urethra  
Vaginal  Administration into the vagina 
1361   
39