Product Identifiers 
Under the Drug Supply 
Chain Security Act 
Questions and Answers 
Guidance for Industry 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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) 
 
June 2021 
Labeling 
   
Product Identifiers 
Under the Drug Supply 
Chain Security Act 
Questions and Answers 
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 
http://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 Avenue, Bldg. 71, Room 3128 
Silver Spring, MD 20993-0002 
Phone: 800-835-4709 or 240-402-8010 
Email: ocod@fda.hhs.gov 
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm 
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-
guidances 
 
 
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) 
 
 June 2021 
Labeling 
  Contains Nonbinding Recommendations 
 
TABLE OF CONTENTS 
 
 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  DEFINITIONS .................................................................................................................. 1 
III.  BACKGROUND ............................................................................................................... 3 
IV.  SCOPE OF GUIDANCE .................................................................................................. 4 
V.  PRODUCT IDENTIFIERS UNDER THE DSCSA ....................................................... 4 
VI.  COMPLIANCE POLICY FOR PRODUCT IDENTIFIER REQUIREMENTS ....... 4 
VII.  PRODUCTS THAT ARE SUBJECT TO THE PRODUCT IDENTIFIER 
REQUIREMENTS UNDER THE DSCSA ................................................................................. 5 
VIII.  LINEAR BARCODE REQUIREMENTS UNDER 21 CFR 201.25 ............................. 5 
IX.  QUESTIONS AND ANSWERS ....................................................................................... 7 
A.  Agency Contacts ............................................................................................................................. 7 
B.  Product Identifiers ......................................................................................................................... 7 
C.  Submission of Label Changes Under the DSCSA ..................................................................... 13 
D.  The Product Identifier Requirement of the DSCSA and the Linear Barcode Requirement 
Under 21 CFR 201.25 ........................................................................................................................... 15 
E.  Examples of When the Product Identifier Is Required Under the DSCSA and the Linear 
Barcode Is Required Under  201.25 .................................................................................................. 15 
  Contains Nonbinding Recommendations 
 
Product Identifiers Under the Drug Supply Chain Security Act 
Questions and Answers 
Guidance for Industry1 
 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this 
topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an 
alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an 
alternative approach, contact the FDA staff responsible for this guidance as listed on the title page.  
 
 
 
I.  INTRODUCTION  
 
This guidance is intended to address anticipated questions regarding product identifiers2 that are 
required under section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 
360eee-1), as added by the Drug Supply Chain Security Act (DSCSA) (Title II of Public Law 113-
54), for packages and homogenous cases of certain drug products.3,4,5,6 Section 582(b)(2) and (e)(2) 
require manufacturers and repackagers, respectively, to affix or imprint a product identifier to each 
package and homogenous case of a product intended to be introduced in a transaction7 in(to) 
commerce beginning November 27, 2017, and November 27, 2018, respectively.8 This guidance is 
intended to clarify FDAs interpretation of both these requirements, including as they relate to the 
linear barcode requirements under 21 CFR 201.25.9                                                                                                 
 
In general, FDAs guidance documents do not establish legally enforceable responsibilities. Instead, 
guidances describe the Agencys current thinking on a topic and should be viewed only as 
recommendations, unless specific regulatory or statutory requirements are cited. The use of the 
word should in Agency guidances means that something is suggested or recommended, but not 
required.  
II.  DEFINITIONS 
 
 
1 This guidance has been prepared by the Center for Drug Evaluation and Research (CDER) in cooperation with the 
Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration.  
2 Select definitions are provided under section 581 of the FD&C Act (21 U.S.C. 360eee). Product identifier is defined 
under section 581(14) of the FD&C Act. 
3 For the purposes of this guidance, all references to drug products include both human drugs and biological drug 
products regulated by CDER and CBER unless otherwise specified. 
4 Package is defined under section 581(11) of the FD&C Act. 
5 Homogeneous case is defined under section 581(7) of the FD&C Act. The terms homogeneous and homogenous 
are used interchangeably throughout the DSCSA. FDA has chosen to use only the term homogenous throughout this 
guidance. 
6 Product is defined under section 581(13) of the FD&C Act. 
7 Transaction is defined under section 581(24) of the FD&C Act. 
8 For product identifier requirements, see section 582(a)(9), (b)(2), and (e)(2) of the FD&C Act. 
9 The term barcode is used in the DSCSA and bar code in  201.25. These terms may be used interchangeably; 
however, for this guidance, FDA has chosen to use only the term barcode except when quoting applicable language 
from a statute or regulation. 
  1 Contains Nonbinding Recommendations 
 
Dispenser is defined under section 581(3) of the FD&C Act as  
 
(A)   a retail pharmacy, hospital pharmacy, a group of chain pharmacies under 
common ownership and control that do not act as a wholesale distributor, or any 
other person authorized by law to dispense or administer prescription drugs, and 
the affiliated warehouses or distribution centers of such entities under common 
ownership and control that do not act as a wholesale distributor; and 
 
(B)   does not include a person who dispenses only product to be used in animals in 
accordance with section 512(a)(5). 
 
Homogenous case is defined under section 581(7) of the FD&C Act as a sealed case containing 
only product that has a single National Drug Code number belonging to a single lot. 
 
Manufacturer is defined under section 581(10) of the FD&C Act as 
 
(A)  a person that holds an application approved under section 505 or a license issued 
under section 351 of the Public Health Service Act for such product, or if such 
product is not the subject of an approved application or license, the person who 
manufactured the product; 
 
(B)  a co-licensed partner of the person described in subparagraph (A) that obtains the 
product directly from a person described in this subparagraph or subparagraph 
(A) or (C); or 
 
(C)  an affiliate of a person described in subparagraph (A) or (B) that receives the 
product directly from a person described in this subparagraph or subparagraph 
(A) or (B). 
 
Package is defined under section 581(11) of the FD&C Act as the smallest individual saleable 
unit of product for distribution by a manufacturer or repackager that is intended by the 
manufacturer for ultimate sale to the dispenser of such product. For purposes of this definition, 
individual saleable unit is defined under section 581(11)(B) of the FD&C Act as the smallest 
container of product introduced into commerce by the manufacturer or repackager that is intended 
by the manufacturer or repackager for individual sale to a dispenser. 
 
National Drug Code (NDC) is a numeric code under 21 CFR 207.33. Each finished drug product 
or unfinished drug subject to the listing requirements of part 207 must have a unique NDC to 
identify its labeler, product, and package size and type. 
 
Product is defined under section 581(13) of the FD&C Act as a prescription drug in a finished 
dosage form for administration to a patient without substantial further manufacturing (such as 
capsules, tablets, and lyophilized products before reconstitution). See Section VI below for a 
discussion of the products that fall under this definition.  
 
Product identifier is defined under section 581(14) of the FD&C Act as a 
  2 Contains Nonbinding Recommendations 
 
 
... standardized graphic that includes, in both human-readable form and on a machine-
readable data carrier that conforms to the standards developed by a widely recognized 
international standards development organization, the standardized numerical identifier, 
lot number, and expiration date of the product.  
 
Repackager is defined in section 581(16) of the FD&C Act as a person who owns or operates 
an establishment that repacks and relabels a product or package for  (A) further sale; or (B) 
distribution without a further transaction. 
 
Standardized numerical identifier is defined under section 581(20) of the FD&C Act as 
 
... a set of numbers or characters used to uniquely identify each package or homogenous 
case that is composed of the National Drug Code (NDC) that corresponds to the specific 
product (including the particular package configuration) combined with a unique 
alphanumeric serial number of up to 20 characters. 
 
Transaction is defined under section 581(24) of the FD&C Act as the transfer of product 
between persons in which a change of ownership occurs. The definition includes a list of 18 
exemptions to the definition of transaction.  
 
 
III.  BACKGROUND 
 
The DSCSA was signed into law on November 27, 2013. The DSCSA outlines critical steps to 
build an electronic, interoperable system by November 27, 2023, that will identify and trace 
certain prescription drugs as they are distributed within the United States. Section 202 of the 
DSCSA, which added new sections 581 and 582 to the FD&C Act, set forth new definitions and 
requirements related to product tracing, product identifiers, and verification for manufacturers, 
repackagers, wholesale distributors, and dispensers to facilitate the tracing of product through the 
pharmaceutical distribution supply chain. Failure to comply with the requirements of section 582 
is a prohibited act under section 301(t) of the FD&C Act (21 U.S.C. 331(t)) and is subject to 
enforcement action under the FD&C Act. 
   
  3 Contains Nonbinding Recommendations 
 
IV.  SCOPE OF GUIDANCE 
 
This guidance is intended to help manufacturers and repackagers understand and satisfy the 
requirements of section 582(b)(2) and (e)(2) of the FD&C Act, respectively, to affix or imprint 
a product identifier to each package and homogenous case of product that they intend to 
introduce in a transaction into commerce. The recommendations in this guidance are intended to 
assist manufacturers and repackagers in developing standardized formats for the human- and 
machine-readable information that is contained in the product identifier. The requirements set 
forth in the DSCSA do not change the linear barcode requirements under 21 CFR 201.25. 
 
 
V.  PRODUCT IDENTIFIERS UNDER THE DSCSA 
 
As noted in Section II of this guidance, a product identifier is defined under section 581(14) of 
the FD&C Act as a standardized graphic that includes the products standardized numerical 
identifier (composed of the NDC and a unique alphanumeric serial number), lot number, and 
expiration date, in both human- and machine-readable formats. The machine-readable format 
must be on a data carrier that conforms to the standards developed by a widely recognized 
international standards development organization.10 The product identifier data is specifically 
required under section 582(a)(9) of the FD&C Act to be in a 2-dimensional data matrix 
barcode for packages and in a linear or 2-dimensional data matrix barcode for homogenous 
cases, which can be verified using human-readable or machine-readable methods.11  
 
Under section 582(b)(2)(A) of the FD&C Act, manufacturers are required to affix or imprint a 
product identifier to each package and homogenous case of a product intended to be introduced 
in a transaction into commerce beginning no later than November 27, 2017. Under section 
582(e)(2) of the FD&C Act, repackagers are required to affix or imprint a product identifier to 
each package and homogenous case of a product intended to be introduced in a transaction in 
commerce beginning no later than November 27, 2018. Therefore, each package and 
homogenous case of product intended to be introduced in a transaction into commerce must 
include the NDC, unique serial number, lot number, and expiration date in both human- and 
machine-readable formats.  
 
 
VI.  COMPLIANCE POLICY FOR PRODUCT IDENTIFIER REQUIREMENTS 
 
In the guidance titled Product Identifier Requirements Under the Drug Supply Chain Security Act 
 Compliance Policy, FDA stated that it did not intend to take enforcement action against 
manufacturers who did not, prior to November 27, 2018, affix or imprint a product identifier to 
each package and homogenous case of product intended to be introduced in a transaction into 
 
10 Section 581(14) of the FD&C Act. 
11 See section 582(a)(9) of the FD&C Act.  As described in section 582(a)(9)(A), FDA may decide in the future to allow 
the use of other technologies for data instead of, or in addition to, the 2-dimensional data matrix barcode or linear 
barcode. 
  4 Contains Nonbinding Recommendations 
 
commerce as required by section 582(b)(2)(A) of the FD&C Act.12 As the time frame described in 
this compliance policy has since ended, it no longer represents the Agency's thinking in terms of 
enforcement policy. 
 
 
VII.  PRODUCTS THAT ARE SUBJECT TO THE PRODUCT IDENTIFIER 
REQUIREMENTS UNDER THE DSCSA 
 
The product identifier requirements of section 582(b)(2)(A) and (e)(2)(A) of the FD&C Act 
apply to packages and homogenous cases of product intended to be introduced into commerce 
via a transaction.13 A product under section 581(13) of the FD&C Act is a prescription drug 
in finished dosage form for administration to a patient without substantial further 
manufacturing.  
 
The following prescription drug products are excluded from the definition of a product under 
the DSCSA, and thus are not subject to the product identifier requirements:14  
 
  blood or blood components intended for transfusion 
  certain radioactive drugs or radioactive biological products15  
  imaging drugs 
  certain intravenous products16  
  any medical gas17  
  homeopathic drugs marketed in accordance with applicable guidance under the  
FD&C Act  
  drugs compounded in compliance with sections 503A or 503B of the FD&C Act  
(21 U.S.C. 353a or 353b). 
 
 
VIII.  LINEAR BARCODE REQUIREMENTS UNDER 21 CFR 201.25 
 
Considering the product identifier requirements under the DSCSA, manufacturers and 
repackagers have asked FDA whether some of their products are still required under 21 CFR 
201.25 to include a linear barcode. The linear barcode requirements were established for 
different purposes than the DSCSA requirements and apply to additional FDA-regulated 
products and packaging in some instances, and are still in effect. In the Federal Register of 
 
12 See guidance for industry Product Identifier Requirements Under the Drug Supply Chain Security Act  Compliance 
Policy (September 2018). We update guidances periodically. For the most recent version of a guidance, check the FDA 
Drugs guidance web page at 
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. 
13 There are exemptions to the definition of transaction (see section 581(24)(B) of the FD&C Act).  
14 Section 581(13) of the FD&C Act, defining product.  
15 Radioactive drugs and radioactive biological products excepted from the definition of product under the DSCSA 
are defined in 21 CFR 600.3(ee) and regulated by the Nuclear Regulatory Commission or by a state, pursuant to an 
agreement with such Commission under section 274 of the Atomic Energy Act of 1954 (42 U.S.C. 2021). 
16 Certain intravenous products include those described under sections 581(24)(B)(xiv), (xv), and (xvi) of the FD&C 
Act. 
17 As defined in section 575 of the FD&C Act (21 U.S.C. 360ddd). 
  5 Contains Nonbinding Recommendations 
 
February 26, 2004 (69 FR 9120), FDA published a final rule requiring certain human drug and 
biological product labels to have a linear barcode that contains, at a minimum, the drugs NDC 
number ( 201.25).18 Manufacturers, repackers (also known as repackagers), relabelers, and 
private label distributors of human prescription drug products, biological products, and over-the-
counter (OTC) drug products dispensed pursuant to an order and commonly used in hospitals, 
are subject to the linear barcode requirement. The linear barcode must appear on the drugs label 
as defined by section 201(k) of the FD&C Act (21 U.S.C. 321(k)). FDA has interpreted that 
requirement to mean the linear barcode should be on the outside container or wrapper, as well as 
on the immediate container unless the barcode is readily visible and machine-readable through 
the outside container or wrapper.19 
  
As stated in the preamble to the final rule: 
 
Bar codes can help reduce or detect potential medication errors by enabling health care 
professionals to check whether they are giving the right drug via the right dose and right 
route of administration to the right patient at the right time.20 
 
The preamble contemplated that linear barcodes, the use of scanning equipment, and 
computerized databases would be part of a system that could help reduce the number of 
medication errors that occur in hospitals and other health care settings.21 
 
Manufacturers, repackers, relabelers, and private label distributors of drug products who are 
subject to the establishment registration and drug listing requirements in section 510 of the 
FD&C Act (21 U.S.C. 360) are responsible for placing the appropriate barcode on the product.22 
The following prescription drug products, however, are exempted under  201.25 from the linear 
barcode requirements:  
 
  prescription drug samples 
  allergenic extracts 
  intrauterine contraceptive devices regulated as drugs 
  medical gases 
  radiopharmaceuticals23  
  low-density polyethylene form fill and seal containers that are not packaged with an 
overwrap.  
 
In addition, the linear bar code requirement does not apply to prescription drugs that are sold by 
a manufacturer, repacker, relabeler, or private label distributor directly to patients, unless 
versions of that same drug are also sold to or used in hospitals.24 
 
18 See 69 FR 9120 at 9140 (Feb. 26, 2004), https://www.gpo.gov/fdsys/pkg/FR-2004-02-26/pdf/04-4249.pdf. 
19 Id. at 9120. 
20 Id. at 9121. 
21 Id. at 9120.  
22 See 21 CFR 207.17 regarding what establishments are required to register and list drug products.  Private label 
distributors who do not also manufacture, repack, relabel, or salvage drugs are not required to register under part 207.   
23 For the purposes of the linear barcode requirements, radiopharmaceuticals are considered radioactive drugs or 
radioactive biological products, as defined in 21 CFR 310.3(n) and 21 CFR 600.3(ee), respectively. 
24  201.25(b)(1)(ii).  
  6 Contains Nonbinding Recommendations 
 
 
IX.  QUESTIONS AND ANSWERS 
 
A.  Agency Contacts  
 
1.  Who should be contacted for questions related to barcode requirements for drug 
packages and homogenous cases under the DSCSA?  
 
For CDER-regulated products, inquiries should be emailed to: 
CDERBarcodeQuestions@fda.hhs.gov. For CBER-regulated products, inquiries should be 
emailed to CBERs Office of Communication, Outreach and Development at: 
ocod@fda.hhs.gov. 
 
2.  Who should be contacted for questions related to linear barcode requirements 
under 21 CFR 201.25?  
 
Because the linear barcode requirements apply to multiple FDA-regulated products (i.e., human 
prescription drug products, biological products, and OTC drug products), you should contact the 
appropriate review division for your product.  
 
For general linear barcode questions, email CDERBarcodeQuestions@fda.hhs.gov for CDER-
regulated products, or CBERs Office of Communication, Outreach and Development at 
ocod@fda.hhs.gov for CBER-regulated products. 
  
B.  Product Identifiers 
 
3.  How should machine-readable formats include the product identifier required by 
the DSCSA? 
 
The product identifier must be included in a 2-dimensional (2D) data matrix barcode when 
affixed to or imprinted on a package and in a linear barcode or 2D data matrix barcode when 
affixed to or imprinted on a homogenous case.25 
 
4.  How should the human-readable portion of the product identifier required by the 
DSCSA be formatted to appear on the drug package label?  
 
To aid healthcare practitioners that may use product information, such as by checking the expiration 
date or recording the NDC and lot number into a patient record, FDA recommends that the human-
readable portion of the product identifier appear in the following format:26 
 
NDC: [insert products NDC] 
SERIAL: [insert products serial number] 
 
25 See section 582(a)(9) of the FD&C Act.  FDA has not specified an alternative format to the 2D data matrix bar code 
for packages. 
26 See draft guidance for industry, Safety Considerations for Container Labels and Carton Labeling Design to Minimize 
Medication Errors (April 2013). When final, this guidance will represent FDAs current thinking on this topic.  
  7 Contains Nonbinding Recommendations 
 
LOT: [insert products lot number] 
EXP: [insert products expiration date]  
 
FDA recognizes that space limitations may necessitate placement of the elements of the human-
readable portion of the product identifier in a different order or location on the drug package 
label. 
 
The NDC and serial number are the two components of the Standardized Numerical Identifier 
(SNI) as defined in section 581(20) of the FD&C Act. The product identifier requires the SNI, lot 
number, and expiration date. The drug package label must include the product identifier 
information (i.e., the NDC, serial number, lot number, and expiration date) in both the human-
readable form and the machine-readable, 2D data matrix barcode format. For homogenous cases, 
the machine-readable portion of the product identifier may use either a linear barcode or 2D data 
matrix barcode format. FDA recognizes that variations exist in how to abbreviate aspects of the 
human-readable portion of the label for the NDC, serial number, lot number, and expiration date. 
For example, the abbreviation No. is sometimes used instead of number, or there might be 
no reference to number or any abbreviation thereof. In addition, the characters for each term 
are sometimes upper or lower case, or a combination of both. The Agencys recommendations 
for how the information in the human-readable portion of the product identifier should be 
displayed when affixed to, or imprinted on, packages and homogenous cases of product are 
provided below. 
 
a.  National Drug Code 
 
FDA recommends the term National Drug Code be abbreviated as NDC on the drug package 
label. The NDC for a product should be displayed in its 3-segment format,27 such that the segments 
identify, respectively, the labeler, product, and package size and type.28 If necessitated by space 
limitations, the NDC may appear at a different location on the drug package label than the other 
elements of the human-readable portion of the product identifier.29  
 
b.  Serial number 
 
If the term serial number is abbreviated on the drug package label, it should be done in a manner 
that will allow the reader to distinguish and understand the abbreviation to mean serial number. 
FDA recommends using one of the following abbreviations for serial number:   
 
Examples of Abbreviations for Serial Number 
Serial 
Serial No. 
Ser. No. 
 
27 An alternatively formatted NDC that is approved for use by the relevant Center Director may be used for certain 
human cells, tissues, and cellular and tissue-based products (HCT/Ps). See 21 CFR 207.33(b)(4). 
28 See 21 CFR 207.33.  
29 For example, FDA is aware that it is common practice for the products NDC to be affixed or imprinted on the 
principal display panel. 
 
  8 Contains Nonbinding Recommendations 
 
S/N 
 
We believe that these abbreviations are readily distinguished and understood by readers to mean 
serial number.  
 
The serial number shall be comprised of up to 20 alphanumeric characters, as described in section 
581(20) of the FD&C Act. If necessitated by space limitations, the serial number may be displayed 
at a different location on the drug package label than the other elements of the human-readable 
portion of the product identifier, and the human-readable serial number need not be displayed 
directly next to or after the NDC number. 
  
c.  Lot number 
 
If the term lot number is abbreviated on the drug package label, it should be done in a manner 
that will allow the reader to distinguish and understand the abbreviation to mean lot number. 
FDA recommends using one of the following abbreviations for lot number:   
 
Examples of Abbreviations for Lot Number 
Lot 
Lot No. 
LOT 
 
We believe that these abbreviations are readily distinguished and understood by readers to mean 
lot number. 
 
The lot number may contain letters and numbers, as determined by the manufacturer or repackager 
of the product, and if necessitated by space limitations may be displayed at a different location on 
the drug package label than the other elements of the human-readable portion of the product 
identifier. 
 
d.  Expiration date 
 
If the term expiration date is abbreviated on the drug package label, it should be done in a manner 
that will allow the reader to distinguish and understand the abbreviation to mean expiration date.  
FDA recommends using one of the following abbreviations for expiration date: 
   
Examples of Abbreviations for Expiration Date 
EXP. 
EXP 
EXPIRY 
EXP DATE 
Exp. Date 
 
We believe that these abbreviations are readily distinguished and understood by readers to mean 
expiration date. 
 
  9 Contains Nonbinding Recommendations 
 
The expiration date may contain letters or numbers as determined by the manufacturer or 
repackager of the product. FDA recommends that the human-readable expiration date on the drug 
package label include a year, month, and day in YYYY-MM-DD format (ex., 2021-01-01) if using 
only numerical characters (noting that day should not be expressed as 00), or in YYYY-MMM-
DD (ex., 2021-JAN-01) if using alphabetical characters to represent the month. If there are space 
limitations on the drug package, the human-readable text may include only a year and month, 
expressed as YYYY-MM (ex., 2021-01) if using only numerical characters or YYYY-MMM (ex., 
2021-JAN) if using alphabetical characters to represent the month. FDA recommends using a 
hyphen or forward slash to separate the portions of the expiration date. 
 
In situations where the expiration date includes only a year and month due to space limitations, 
FDA considers the drugs actual expiration date to be the last calendar day of the month that is 
included in the human-readable expiration date on the drug package label. For example, a human-
readable expiration date of 2021-07 (or 2021-JUL) would be interpreted by FDA to mean that the 
drug expires on July 31, 2021.  
 
5.  Can the GS1 Global Trade Identification Number (GTIN) be used in place of the 
NDC to comply with the requirements for a human-readable NDC as part of the 
product identifier?  
 
We recommend against using the GTIN in place of a separate NDC in the human-readable 
portion of the product identifier. Under the DSCSA, the product identifier must include the NDC 
in both human-readable and machine-readable form.30 As described in 21 CFR 207.33(b)(1), the 
human-readable NDC is generally a 10 or 11-digit number, in a 3-segment format, that identifies 
the labeler, product, and trade package size/type.31 We recommend that this 3-segment format be 
followed for purposes of including the NDC in the human-readable format portion of product 
identifiers because it is a well-recognized means of representing the NDC and its use benefits 
patient safety.   
 
The GTIN in its human-readable format contains additional digits and does not present the NDC 
in its traditional 3-segment format. Departing from the well-established 3-segment NDC by 
simply embedding unformatted NDC digits within the larger GTIN would obscure ready 
identification of the NDC by human readers. The traditional 3-segment NDC format helps users 
readily identify each of the 3-segments (labeler code, product code, and package size/type), and 
use of each segment varies depending on the type of user.32 Further, the traditional 3-segment 
format helps users visually identify the product as a drug, in differentiation from dietary 
 
30 Section 581(14) of the FD&C Act (defining product identifier as a standardized graphic that includes, in human-
readable and machine-readable form, the standardized numerical identifier); Section 581(20) of the FD&C Act 
(defining standardized numerical identifier as a set of numbers or characters composed of (a) the National Drug Code 
that corresponds to the specific product (including the particular package configuration) combined with (b) a unique 
alphanumeric serial number of up to 20 characters).   
31 See 21 CFR 207.33(b)(1). Under  207.33(b)(4), an alternatively formatted NDC that is approved for use by the 
relevant Center Director may be used for certain HCT/Ps. 
32 Uses of the 3-segment NDC include verifying whether a product is the correct product for dosing/administration or 
dispensing to a patient; verifying product when the product code is imprinted on the corresponding tablet/capsule; 
purchasing/inventory management; drug information (as many databases are searched using the NDC); and medical 
records utilizing the NDC in the 3-segment format. 
  10 Contains Nonbinding Recommendations 
 
supplements and other non-drug products which may display a non-segmented universal product 
code (UPC). Accordingly, FDA is concerned that using the GTIN in place of the 3-segment 
NDC in the human-readable portion of the product identifier could lead to improper 
identification of the NDC and drug product, thereby increasing the risks to patient safety.   
 
FDA recognizes that in addition to the 3-segment NDC, companies might also affix or imprint 
the human-readable GTIN on the package label, in close proximity to product identifier 
elements.33    
 
Regarding the machine-readable portion of the product identifier (2D data matrix barcode), FDA 
also understands that companies utilize the GTIN to encode the NDC into the 2D data matrix 
barcode. FDA views this practice as satisfying the requirement for a machine-readable NDC in 
product identifiers. 
 
6.  Can a Quick Response (QR) code be used as a product identifier?  
 
No. Section 582(a)(9) of the FD&C Act requires that the product identifier be encoded in a 2D 
data matrix barcode for packages and a 2D data matrix barcode or linear barcode for 
homogenous cases. While a QR code is a type of 2-dimensional barcode, it is not the same as a 
2D data matrix barcode and does not encode the same type of information. The 2D data matrix 
barcode encodes specific product information and has been adopted as a data carrier for the 
healthcare sector.34 As such, a QR code cannot replace the 2D data matrix barcode on packages 
or the linear or 2D data matrix barcode on homogenous cases as required under the DSCSA.  
 
7.  Should the 2D data matrix barcode be near the human-readable portion of the 
product identifier on the package? 
 
Yes. If space permits, FDA recommends the 2D data matrix barcode be affixed or imprinted near 
or next to elements of the human-readable portion of the product identifier on a package (see 
Question and Answer #4 above). FDA believes this placement would help downstream trading 
partners (repackagers, wholesale distributors, and dispensers) associate the information encoded 
in the 2D data matrix barcode with the human-readable information. We are aware that some 
trading partners may utilize the 2D data matrix barcode to electronically read or retrieve the 
encoded information for reasons such as data entry for inventory purposes, patient medical 
records, or product verification. Positioning the 2D data matrix barcode near the human-readable 
portion of the product identifier, when space permits, may help reduce the confusion when a 
product has multiple types of barcodes on the label because they are either required by law or are 
included voluntarily for other purposes (e.g., QR codes).  
 
In situations where multiple barcodes are affixed to, or imprinted upon, a package, each barcode 
should be surrounded by sufficient blank space to avoid confusion and ensure that the barcode 
can be scanned correctly. For example, a 2D data matrix barcode can be affixed to, or imprinted 
upon, one side of a package and the linear barcode, as appropriate, can be placed on the opposite 
 
33 See FD&C Act section 581(14). 
34 See GS1 General Specifications (Release 18, Ratified, January 2018), Section 2.1.6 Healthcare primary packaging 
(https://www.gs1.org/sites/default/files/docs/barcodes/GS1_General_Specifications.pdf).  
  11 Contains Nonbinding Recommendations 
 
side. The space between the barcodes in this example would help prevent individuals from 
accidently scanning the wrong barcode. 
 
8.  What level or size of a package is required to have a product identifier? 
 
Under section 582(b)(2) and (e)(2) of the FD&C Act, manufacturers and repackagers are 
required to affix or imprint product identifiers to packages and homogenous cases of product. 
Based on the definition of package,35 this means that the product identifier must be affixed or 
imprinted on the smallest individual saleable unit of product for distribution by a manufacturer or 
repackager that is intended by the manufacturer for ultimate sale to a dispenser36 of such product. 
 
Therefore, manufacturers and repackagers must determine the smallest individual saleable unit 
product configuration that they intend to be sold to the dispenser, and affix or imprint a product 
identifier (included in a 2-dimensional data matrix barcode) to that package. 
 
To determine what constitutes a package, manufacturers and repackagers should consider how 
their packages of product may be opened and separated by wholesale distributors, who may sell 
smaller individual units of product that were inside the larger package to a dispenser for ultimate 
dispensing or administration to a patient. For example, although a carton of 10 individual product 
units may be sold to a dispenser, manufacturers and repackagers may want to apply a product 
identifier to each of the 10 product units in the carton if it is reasonably foreseeable that a 
wholesale distributor might sell individual product units to a dispenser. See Section IX.E of this 
guidance for examples of potential individual saleable units and a discussion of the applicable 
barcode requirements. Also, see Section IX.C for additional regulatory requirements that may 
apply when determining whether to affix or imprint a product identifier to a product unit. 
 
9.  Do manufacturer and repackager activities related to affixing or imprinting the 
product identifier need to comply with current good manufacturing practice 
(CGMP)?  
 
Yes, the CGMP requirements under 21 CFR parts 210 and 211 apply to the manufacture, 
processing, packing, or holding of a drug product, including packaging and labeling operations, 
testing, and quality control of drugs.  
 
10.  Can manufacturers and repackagers request a waiver, exemption, or exception 
from the DSCSA requirement to include a product identifier? 
 
Yes. FDA has authority under section 582(a)(3) of the FD&C Act to grant a waiver, exception, 
or exemption for products and transactions from certain requirements in section 582. 
Manufacturers and repackagers should use the processes set forth in FDAs draft guidance for 
industry Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the 
 
35 Package is defined in section 581(11) of the FD&C Act.  
36 Dispenser is defined in section 581(3) of the FD&C Act. 
  12 Contains Nonbinding Recommendations 
 
Federal Food, Drug, and Cosmetic Act to make a request.37 This guidance also describes what 
information should be included with the request.  
 
11.  Do the product identifier requirements under the DSCSA apply to prescription 
drugs marketed without FDA approval? 
 
Yes. The DSCSA establishes requirements for products, which as defined under section 
581(13) of the FD&C Act are generally prescription drugs in a finished dosage form for 
administration to patients without substantial further manufacturing. Prescription drugs in the 
DSCSA refer to drugs for human use,38 which meet the requirements of section 503(b)(1) of the 
FD&C Act (21 U.S.C. 353(b)(1)), independent of approval status. 
 
12.  For prescription drugs that are marketed without FDA approval, is the 
manufacturer required to submit the product identifier as part of its product 
labeling during registration and listing?  
 
Yes. FDA interprets the definition of labeling in section 201(m) of the FD&C Act to include 
the product identifier. Accordingly, as part of registration and listing under 21 CFR part 207, a 
manufacturer of any prescription drug for commercial distribution39 must submit a copy of all 
current labeling as specified under  207.49(a)(15)(i), independent of approval status.  
 
C.  Submission of Label Changes Under the DSCSA 
  
13.  How should manufacturers or repackagers submit a package label change to FDA 
that is solely for incorporating the product identifier of an already approved 
prescription drug?40  
 
Applicants who submit annual reports should be aware of product identifier changes made by 
manufacturers and repackagers in the supply chain. Under section 582(a)(8) of the FD&C Act, a 
change made to the drug package label solely to incorporate the product identifier may be 
submitted in an applicants annual report41 in accordance with 21 CFR 314.70(d). Under  
314.70(d), the applicant must document certain changes in the next annual report in accordance 
with  314.81(b)(2).42 Under  314.81(b)(2)(i), the annual report must contain a brief summary 
of significant new information from the previous year that might affect the safety, effectiveness, 
or labeling of the drug product. 
 
A table of contents may be included in the annual report which indicates the inclusion of the 
labeling change for incorporating the product identifier on products. 
 
37 Draft guidance for industry Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the 
Federal Food, Drug, and Cosmetic Act (May 2018). When finalized, this guidance will represent FDAs current 
thinking on this topic.  
38 See section 581(12) of the FD&C Act.  
39 Commercial distribution is defined in 21 CFR 207.1. 
40 For purposes of this guidance, the term drug includes biological drug products that are licensed by CDER and CBER.  
41 For purposes of this guidance, the term establishment, as used in section 582(a)(8) of the FD&C Act, refers to the 
applicant.  
42 For biological products, see 21 CFR 601.12(d) for additional changes to be described in an annual report.  
  13 Contains Nonbinding Recommendations 
 
 
In certain instances, it may be appropriate to submit a labeling change in a Prior Approval 
Supplement (PAS) or in a Changes Being Effected supplement instead of in an annual report.43 
 
14.  Is a manufacturer or repackager required to submit to FDA information encoded in 
the product identifier for each package and homogenous case of product? 
 
In general, the information encoded in each product identifier for packages and homogenous 
cases is not required to be submitted to FDA. However, FDA may request information from a 
manufacturer or repackager in the event of a recall or to investigate a suspect or illegitimate 
product. In this circumstance, the manufacturer or repackager must provide the applicable 
transaction information,44 which includes the NDC number and lot number, as well as the 
transaction history and transaction statement for the product.45 
 
Also, FDA may request information from a manufacturer or repackager to verify a product 
identifier if FDA has made the determination that a suspect product is in the possession or 
control of such manufacturer or repackager. In this circumstance, the manufacturer or repackager 
must provide relevant information46 in response that FDA can use to determine whether the 
product identifier affixed to or imprinted on a package or homogenous case corresponds to the 
standardized numerical identifier47 or lot number and expiration date assigned to the product by 
the manufacturer or repackager. 
 
15.  Can a manufacturer submit a placeholder when submitting initial or updated 
product labeling as part of an application or supplemental application (i.e., New 
Drug Application [NDA], Abbreviated New Drug Application [ANDA], or Biologics 
License Application [BLA]) to reflect its commitment to affix or imprint the product 
identifier on its product? 
 
Yes. CDER and CBER will accept the submission of a drug product label that contains a 
placeholder when submitting initial or updated product labeling as part of an application or 
supplemental application (i.e., NDA, ANDA, or BLA) in lieu of an image of the final product 
identifier that the manufacturer intends to use at the time of drug manufacturing. The placeholder 
should be represented on the initial or updated product labeling submission as a blank space with 
labels to sufficiently describe what information will be placed in that space at the time the 
product is manufactured (e.g., lot number and expiration date) (see Question and Answer #4 
above for examples of how to label each element of information). 
 
 
43 For further information, consult the guidance for industry Changes to an Approved NDA or ANDA (April 2004). 
44 See section 582(b)(1)(B) of the FD&C Act for manufacturer requirement; section 582(e)(1)(C) of the FD&C Act for 
repackager requirement. 
45 Transaction information, transaction history, and transaction statement are defined in section 581(26), (25), and (27) 
of the FD&C Act, respectively. 
46 See section 582(b)(4)(A) of the FD&C Act for manufacturer requirement; section 582(e)(4)(A) of the FD&C Act for 
repackager requirement. 
47 Standardized numerical identifier is defined in section 581(20) of the FD&C Act.  
  14 Contains Nonbinding Recommendations 
 
D.  The Product Identifier Requirement of the DSCSA and the Linear Barcode 
Requirement Under 21 CFR 201.25 
 
16.  Is my product package required to have both a linear barcode and a 2D data matrix 
barcode?  
 
It depends. There will be instances when a product package is required to have both a linear 
barcode, pursuant to  201.25, and a 2D data matrix barcode, pursuant to the DSCSA. For a 
product for which a manufacturer, under the DSCSA, has identified the smallest individual 
saleable unit intended for ultimate sale to a dispenserwhich is a package under FD&C Act 
section 581(11)the package would generally require a 2D data matrix barcode to comply with 
the DSCSA48 in addition to the requisite linear barcode under  201.25. See Section E of this 
guidance for examples of when a 2D data matrix barcode may not be required.  
 
17.  With the enactment of the DSCSA, is the guidance for industry Bar Code Label 
Requirements Questions and Answers (August 2011) still applicable for the linear 
barcode rule under  201.25?  
 
Yes. The guidance for industry Bar Code Label Requirements Questions and Answers remains 
applicable to the linear barcode rule under  201.25 unless or until such time the guidance is 
revised, replaced, or withdrawn. This guidance should be consulted for questions specific to the 
linear barcode requirements under  201.25.49 
 
18.  Can I put only a 2D data matrix barcode on my product as required under the 
DSCSA in lieu of the linear barcode that is required under  201.25, since it also 
includes the NDC number? 
 
No. At this time, a 2D data matrix barcode may not be used as a substitution for a linear barcode 
when one is required under  201.25 for packages of product. 
 
19.  Can a manufacturer or repackager put the 2D data matrix barcode, as required 
under the DSCSA, on all levels of packaging, including the immediate container?  
 
Yes. A manufacturer or repackager may voluntarily put the 2D data matrix barcode on all levels 
of packaging, including the immediate container, if the product remains compliant with all other 
labeling requirements, including the linear barcode requirements under  201.25.  
 
E.  Examples of When the Product Identifier Is Required Under the DSCSA and 
the Linear Barcode Is Required Under  201.25  
 
For each of their products, manufacturers and repackagers are responsible for determining the 
smallest individual saleable unit that they intend for ultimate sale to a dispenser. Under the 
 
48 See FD&C Act sections 582(b)(2)(A) and 582(a)(9). 
49 See guidance for industry Bar Code Label Requirements Questions and Answers (August 2011), available at 
https://www.fda.gov/files/vaccines%2C%20blood%20%26%20biologics/published/Guidance-for-Industry--Bar-Code-Label-
Requirements.pdf). 
  15 Contains Nonbinding Recommendations 
 
DSCSA, both a 2D data matrix barcode and the human-readable portion of the product identifier 
are required to be affixed or imprinted on each such individual saleable unit. While other levels 
of product packaging may exist that do not require a 2D data matrix barcode, as noted in 
Question and Answer #19, manufacturers and repackagers may voluntarily affix or imprint a 2D 
data matrix barcode if the product remains compliant with all other labeling requirements, 
including the linear barcode requirements under  201.25.  
 
The following table provides examples of different units of a package or case and what barcode 
would be required under the DSCSA and under  201.25. It is not an exhaustive list because the 
information required will depend on the specific details of particular product packaging.  
 
Type of Product Identifier  Linear barcode required 
Examples of 
required by the DSCSA  under 21 CFR 201.25(c) 
potential packaging  Unit 
under FD&C Act Sec.  (Yes / No) 
configurations 
582(a)(9)(A) 
A 60-count bottle of  Bottle  2D data matrix barcode  Yes  
tablets   
A homogenous case  Case  Linear barcode or 2D data  No  
of 10 bottles (where    matrix barcode   
each bottle is       
intended for  Bottle  2D data matrix barcode  Yes 
individual sale to a 
dispenser); each 
bottle contains 100 
capsules 
A carton containing  Carton  2D data matrix barcode  Yes 
one bottle of 50-      
count of capsules and  Bottle  None. No requirement for a  Yes 
labeling  2D data matrix barcode
A homogenous case  Case  Linear barcode or 2D data  No  
of 20 cartons (where    matrix barcode    
each carton is       
intended for  Carton   2D data matrix barcode  No  
individual sale to a        
dispenser); each  Pre- None. No requirement for a  Yes 
carton contains 5  filled  2D data matrix barcode  
pre-filled syringes  syringe 
(where each pre- only 
filled syringe is 
available to be sold 
individually as the 
retail package) 
  16 Contains Nonbinding Recommendations 
 
Type of Product Identifier  Linear barcode required 
Examples of 
required by the DSCSA  under 21 CFR 201.25(c) 
potential packaging  Unit 
under FD&C Act Sec.  (Yes / No) 
configurations 
582(a)(9)(A) 
A homogenous case  Case  Linear barcode or 2D data  No  
of 20 cartons (where    matrix barcode    
each carton is       
intended for  Carton   2D data matrix barcode  Yes 
individual sale to a        
dispenser and as the  Pre- None. No requirement for a  Yes 
retail package); each  filled  2D data matrix barcode  
carton contains 5  syringe 
pre-filled syringes   only 
 
  17