Reporting Amount of Listed 
Drugs and Biological Products 
Technical Conformance Guide 
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) 
Center for Veterinary Medicine (CVM) 
 
February 2024 
 
Procedural 
 
Revision 1 
 
         
 
Reporting Amount of Listed 
Drugs and Biological Products 
Technical Conformance Guide 
 
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/guidance-compliance-regulatory-information/guidances-drugs 
and/or 
Office of Communication, Outreach and Development  
Center for Biologics Evaluation and Research 
 Food and Drug Administration 
10903 New Hampshire Ave., Bldg. 71, Room 3128 
Silver Spring, MD 20993-0002 
Phone: 800-835-4709 or 240-402-8010 
Email: ocod@fda.hhs.gov 
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances 
and/or 
Policy and Regulations Staff, HFV-6 
Center for Veterinary Medicine 
Food and Drug Administration 
7500 Standish Place, Rockville, MD 20855 
Email: AskCVM@fda.hhs.gov 
https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-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) 
Center for Veterinary Medicine (CVM) 
 February 2024 
Procedural 
Revision 1 
      Contains Nonbinding Recommendations 
 
TABLE OF CONTENTS 
 
 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 2 
III.  USING THE NEXTGEN PORTAL ................................................................................ 2 
IV.  DATA ELEMENT SPECIFICATIONS ......................................................................... 3 
A.  Submitter Information .................................................................................................................. 4 
B.  Submission Description Elements ................................................................................................ 4 
C.  Data Elements for Reporting the Amount of Listed Drug ......................................................... 6 
D.  Reporting Amount of Drug Products in Finished Package Form ............................................. 7 
E.  Reporting Amount of Drug Products Not in Finished Package Form .................................... 11 
F.  Reporting Amount of Drugs That Are Not Drug Products ...................................................... 13 
V.   RESOURCES .................................................................................................................. 15 
APPENDIX .................................................................................................................................. 16 
Example 1  Finished Dosage Form With Single-Level Packaging ............................................... 16 
Example 2  Finished Dosage Form With Multi-Level Packaging and a Single NDC ................. 17 
Example 3  Finished Dosage Form With Multi-Level Packaging and Multiple NDCs .............. 18 
Example 4  Kit With Multiple Components ................................................................................... 20 
Example 5  Drug Products Not in Finished Package Form .......................................................... 21 
Example 6  Reporting API for Drugs That are Not Formulated by Activity .............................. 22 
Example 7  Reporting API for Drugs That are Formulated by Activity ..................................... 22 
 
 
  Contains Nonbinding Recommendations 
 
Reporting Amount of Listed Drugs and Biological Products 
Technical Conformance Guide 
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 office responsible for this guidance as listed on the title 
page.  
 
 
 
I.  INTRODUCTION  
 
FDA is issuing this Technical Conformance Guide (guide) to assist registrants of drug 
establishments (or their authorized agents) in submitting reports on the amount of each listed 
drug manufactured,2 prepared, propagated, compounded, or processed for commercial 
distribution, as required by section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act 
(FD&C Act),3 as added by section 3112(e) of the Coronavirus Aid, Relief, and Economic 
Security Act (CARES Act).4 This guide supplements the guidance for industry Reporting 
Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act 
(February 2024).5 The guide describes 1) how first-time users can access FDAs NextGen 
Portal6 (the portal) to submit these reports, 2) the different methods for submitting the reports 
through the portal, and 3) the data elements to be included in the reports. 
 
This guide describes the data elements that should be submitted for reporting information under 
section 510(j)(3) by each person who registers with FDA under section 510 of the FD&C Act 
with regard to a listed drug (including a drug product that is in finished package form, a drug 
product that is not in finished package form, an active pharmaceutical ingredient (API), and other 
types of listed drugs, except for biological products or categories thereof exempted by an order 
 
1 This guidance has been prepared by the Center for Drug Evaluation and Research in cooperation with the Center 
for Biologics Evaluation and Research and the Center for Veterinary Medicine, at the Food and Drug 
Administration. You may submit comments on this guidance at any time. Submit comments to Docket No. FDA-
2017-D-6821 (available at https://www.regulations.gov/docket?D=FDA-2017-D-6821). See the instructions in that 
docket for submitting comments on this and other Level 2 guidances. 
2 For the purposes of this guidance, manufacture means the manufacture, preparation, propagation, compounding, 
and processing of a drug. Manufacture, preparation, propagation, compounding, or processing also includes 
repackaging and relabeling. See section 510(a) of the FD&C Act; section 207.1 (21 CFR 207.1) (definitions of 
manufacture and manufacturer). 
3 21 U.S.C. 360(j)(3) 
4 Public Law 166-136 
5 We update guidances periodically. For the most recent version of a guidance, check the FDA guidance web page at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents.  
6 All registrants (not just registrants of CDER-regulated drug establishments) should use the NextGen Portal to 
submit reports that are required under section 510(j)(3) of the FD&C Act, available at: https://edm.fda.gov/. 
  1  Contains Nonbinding Recommendations 
 
under section 510(j)(3)(B)).7 Listed drugs subject to reporting include human drug products 
(including non-exempt biological products) marketed under an approved application; animal 
drug products marketed under an approved application; medical gases;8 homeopathic products; 
products marketed in accordance with requirements under section 505G of the FD&C Act (21 
U.S.C. 355h),9 often referred to as over-the-counter monograph drugs; and animal drug products 
that are not approved, conditionally approved, or indexed under sections 512, 571, and 572 of the 
FD&C Act.  
 
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.  BACKGROUND 
 
On March 27, 2020, the CARES Act was enacted to aid response efforts and ease the economic 
impact of the Coronavirus Disease 2019 (COVID-19). The CARES Act includes authorities to 
enhance FDAs ability to assess, prevent, and mitigate possible drug shortages by, among other 
things, improving FDAs visibility into drug supply chains. Section 3112(e) of the CARES Act 
added section 510(j)(3) to the FD&C Act. Under section 510(j)(3), each person (including 
repackers and relabelers) who registers under section 510 of the FD&C Act with regard to a drug 
must report to FDA annually the amount of each listed drug that was manufactured, prepared, 
propagated, compounded, or processed by such person for commercial distribution. 
 
III.  USING THE NEXTGEN PORTAL 
 
All registrants or their authorized agents should use the portal to submit reports on the amount of 
each listed drug that was manufactured for commercial distribution. If you are a first-time user, 
you will need to register and create an account.10 You may submit reports through the portal by 
1) manually entering information, or 2) uploading data from a comma-separated values (CSV) 
file.11  
 
7 Under section 510(j)(3)(B) of the FD&C Act, FDA may issue an order to exempt certain biological products or 
categories of biological products regulated under section 351 of the Public Health Service Act from some or all of 
the reporting requirements under section 510(j)(3)(A) of the FD&C Act, if FDA determines that applying such 
reporting requirements is not necessary to protect the public health. FDA has issued an order that exempts from 
section 510(j)(3)(A) reporting requirements the following categories of biological products: (i) blood and blood 
components for transfusion; and (ii) cell and gene therapy products, where one lot treats a single patient. See 88 FR 
22454 (April 13, 2023). 
8 For purposes of this guidance, medical gas and designated medical gas have the meanings set forth in section 575 
of the FD&C Act. 
9 Under section 505G of the FD&C Act, certain nonprescription drug products may be lawfully marketed without an 
approved application under section 505 of the FD&C Act if applicable requirements are met. 
10 For further instruction, see the reference guide available at https://www.fda.gov/drugs/drug-
shortages/coronavirus-aid-relief-and-economic-security-act-cares-act-drug-shortage-mitigation-efforts 
11 The three CSV templates showing the data elements are available under the NextGen Resources section at 
https://www.fda.gov/drugs/drug-shortages/coronavirus-aid-relief-and-economic-security-act-cares-act-drug-
shortage-mitigation-efforts 
  2  Contains Nonbinding Recommendations 
 
 
FDA recommends using the manual entry option in the portal for smaller submissions. To enter 
data into the portal manually, you will use the portals interface to provide the appropriate 
information by following a series of prompts, using drop-down boxes, and entering free text. A 
user guide with step-by-step instructions for entering the data manually and submitting reports is 
available via the portal and the website.12 
 
FDA strongly recommends using the option to upload data from a CSV file for larger 
submissions that would be time consuming to enter manually using the portal. If you choose to 
upload data to the portal from a CSV file, it is important that you use the correct template which 
will depend on the reporting pathway (type of drug and its packaging).13,14 Templates for each 
pathway are available via the portal and the website.15 A user guide with step-by-step 
instructions for creating the CSV file and submitting the report using this method is available via 
the portal and the website.16   
 
Technical questions regarding the submission process should be sent to 
EDMSupport@fda.hhs.gov. For questions regarding the content to be submitted in a section 
510(j)(3) report, please contact the appropriate FDA center: 
 
  CDER: DrugAmountReporting@fda.hhs.gov 
  CBER: Office of Communication, Outreach and Development, 800-835-4709 or 240-
402-8010, ocod@fda.hhs.gov 
  CVM: Office of Surveillance and Compliance, 240-402-7002, AskCVM@fda.hhs.gov as 
applicable 
 
IV.  DATA ELEMENT SPECIFICATIONS  
 
In general, the submission process includes three steps:  
1.  Verifying the submitter information: The submitters information is displayed. This 
information automatically populates based on information you submitted when 
registering for your NextGen account.  
2.  Describing the submission: The system will prompt you to provide information about the 
submission. Specifically, you will be asked to identify your role with respect to the 
submission, which calendar year the submission will cover, which reporting pathway 
(type of drug and its packaging) the submission will cover, and how you will complete 
the report (i.e., by submitting manually or by uploading data from a CSV file). If you 
 
12 The website is available at https://www.fda.gov/drugs/drug-shortages/coronavirus-aid-relief-and-economic-
security-act-cares-act-drug-shortage-mitigation-efforts 
13 For further instruction, see the summary diagram and the recommended reporting structures in the guidance for 
industry Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act 
(February 2024).  
14 For the purposes of this guidance, type of drug refers to the following categories: (i) drug that consists of API 
alone; (ii) drug that consists of API with other ingredient(s) but that is not in finished dosage form; (iii) drug product 
that is not in finished package form; and (iv) drug product that is in finished package form. 
15 See footnote 12. 
16 See footnote 12. 
  3  Contains Nonbinding Recommendations 
 
have more than one type of drug, you should submit a separate report for each type of 
drug. 
3.  Completing the report: The system will prompt you to either complete the report by using 
manual entry or by uploading data from an appropriately formatted CSV file.  
 
We describe the data elements relevant to each of these steps in more detail below. These 
descriptions will help you complete the process and understand what information to include for 
the various data elements at each step. For additional information, illustrative examples are also 
included in the Appendix to facilitate reporting amounts of listed drugs. 
 
A.  Submitter Information 
 
The following data elements come directly from your NextGen account profile and are displayed 
for identity verification purposes. These data elements are read-only on this display; you can 
change them by updating your NextGen account profile.17  
 
1.   First Name and Last Name 
 
This is the first and last name you provided during portal registration.  
 
2.  Email 
 
This is the email address you provided during portal registration. 
 
3.  Phone Number and Extension 
 
This is the phone number and optional extension you provided during portal registration. 
 
4.  Organization Name  
 
This is the organization name you provided during portal registration.  
 
5.  Organization Address  
 
This is the address you provided during portal registration. This data element is separated as 
Address Line 1, Address Line 2, City, State/Province, Zip/Postal Code, and Country.  
 
B.  Submission Description Elements 
 
You will enter the following data elements into the portal interface regardless of whether you 
plan to submit the report manually or by uploading data from a CSV file. 
 
 
17 If you are submitting as an authorized agent, see section IV.B.1 for further detail. 
  4  Contains Nonbinding Recommendations 
 
A separate submission is needed for each report, but each report may include multiple 
establishments and multiple national drug codes (NDCs). The elements selected for the 
following fields will apply to every establishment and NDC included in the submission. 
 
1.  Submitter Type 
 
The system will prompt you to indicate whether you are submitting the information as the 
registrant of the reporting establishment or as an authorized agent on behalf of the registrant of 
the reporting establishment.  
  If you are an employee of the reporting establishment or of another organization with or 
under common control or ownership of the reporting establishment (e.g., parent, 
subsidiary, affiliate), you should indicate that you are submitting this information as a 
registrant.  
  If you are not an employee of the reporting establishment or of another organization 
under or with common control or ownership of the reporting establishment, and you are 
authorized by the registrant to submit the information on behalf of the registrant, you 
should indicate that you are reporting as an authorized agent.  
  If your role differs based on the establishment for which you are reporting (i.e., you will 
be submitting as a registrant for some and as an authorized agent for others), you should 
submit these reports separately because the submitter type will apply to every 
establishment and NDC included in the report. For example, if you are an employee of a 
registrant that manufactures its own drugs but also relies on contract manufacturers to 
manufacture drugs that your organization distributes as a private-label distributor, and 
you plan to submit a report for the drugs your establishment manufactures and on behalf 
of your contract manufacturer for the drugs your organization distributes as a private-
label distributor, you should submit one report in which you identify your role as 
registrant and another report in which you identify your role as authorized agent. 
 
2.  Reporting Year 
 
The system will prompt you to select which calendar year the submission covers.  
 
3.  Data Submission Method 
 
The system will prompt you to indicate whether you will submit the report manually or by 
uploading data from a CSV file. 
 
4.  Type of Drug and its Packaging 
 
The system will prompt you to select the type of drug and its packaging for the report you plan to 
submit. You should follow the recommended reporting pathways in the guidance for industry 
Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the 
FD&C Act (section III. B. 5) based on the appropriate type of drug and its packaging.   
 
  5  Contains Nonbinding Recommendations 
 
C.   Data Elements for Reporting the Amount of Listed Drug  
  
The data elements described in this section comprise the specific information for reporting 
(whether manually or by uploading data from a CSV file) the amount of listed drug 
manufactured, prepared, propagated, compounded, or processed for commercial distribution. 
 
A report will not be considered ready for submission unless, at a minimum, it: 
  Identifies at least one establishment by Data Universal Numbering System (DUNS) 
number 
  Identifies at least one drug by NDC at that establishment 
  Identifies the single most relevant business operation performed at that establishment 
with respect to that drug 
 
The portal will automatically check the entered DUNS number and NDC against FDAs internal 
database. If an entered DUNS number or NDC is not found in the internal FDA database, that 
entry will be flagged and a message will display on the screen. If the entry is flagged, you can 
change the entry,18 or you can proceed with your submission if you know the number is valid 
and accurate even though it was not found in the internal FDA database. 
 
The submission format allows you to provide a single report for multiple establishments. 
Recognizing that each establishment may perform different business operations with respect to 
different drugs, instead of identifying the business operations for each NDC, the report is 
designed to allow establishments to identify the different business operations performed and then 
identify the specific drugs, by NDC, for which they perform that business operation. However, as 
explained in more detail below, you should generally associate an NDC with only a single 
business operation at each establishment. 
 
You should select the single business operation that best describes the manufacturing activities 
the establishment performs for each NDC for which you reported for that establishment. This 
business operation should generally match the business operation for that establishment that was 
included in the drug listing.  
 
  MANUFACTURE is the default selection. You should select this option unless one of the 
other business operations applies to the NDC for which you are reporting.19 
  API MANUFACTURE applies only if the NDC for which you are reporting identifies an 
API (active pharmaceutical ingredient) and the establishment performed operations 
besides repackaging or relabeling the API. 
 
18 For a manual submission, you can change the number manually in the portal. To change the number for a CSV 
submission, you need to update the CSV file and resubmit it. 
19 If the business operation from the drug listing file that best describes the activities performed for the listed drug, 
or the single business operation for the listed drug, for that establishment is pack or label, then the registrant 
should, for the purposes of a section 510(j)(3) report, identify manufacture as the single business operation that 
best describes the activities performed for the listed drug. 
  6  Contains Nonbinding Recommendations 
 
  REPACK applies only if the establishment repackaged20 the drug and that drug was 
manufactured at a different establishment. 
  RELABEL applies only if the establishment relabeled21 the drug and that drug was 
manufactured at a different establishment. 
  TRANSFILL applies only if the NDC for which you are reporting is a medical gas and 
the establishment transfills that medical gas. 
  POSITRON EMISSION TOMOGRAPHY DRUG PRODUCTION applies only if the 
NDC for which you are reporting identifies a positron emission tomography drug. 
 
Generally, you should not enter an NDC in association with more than one business operation at 
a specific establishment. For example, if you manufacture both the API and the finished dosage 
form at a single establishment, you should not enter the NDC for the finished dosage form under 
both MANUFACTURE and API MANUFACTURE; you should just enter the NDC under 
MANUFACTURE.22  
 
In some circumstances, it may be appropriate to enter the same NDC under separate business 
operations at a single establishment. For example, if you are a repackager and a relabeler for a 
specific drug, and sometimes you repackage the drug and sometimes you just relabel the drug, 
then you should include the NDC under both REPACK and RELABEL and include the 
appropriate amounts with respect to each business operation. 
 
The guidance for industry Reporting Amount of Listed Drugs and Biological Products Under 
Section 510(j)(3) of the FD&C Act (section III. B. 5) describes three reporting pathways based 
on the type of drug and its packaging. The data elements listed below are specific to each 
reporting pathway. 
 
D.  Reporting Amount of Drug Products in Finished Package Form 
 
1.  Establishment DUNS  
 
You should include the DUNS number for each establishment covered by the submission. The 
DUNS number is a 9-digit number, including any leading zero(s), but without dashes or spaces. 
   
 
20 For purposes of selecting the appropriate business operation, repackaging involves removing the drug from the 
container in which it was received by the establishment and placing the drug into a different container without 
manipulating, changing, or affecting the composition or formulation of the drug (see 21 CFR 207.1). Although the 
establishment may have placed a different label on the repackaged drug, this operation is included within the 
activities associated with repackaging a drug.  
21 For purposes of selecting the appropriate business operation, relabeling involves changing the existing label or 
labels on the drugs package, or changing or altering the drugs existing label, without repackaging or manipulating, 
changing, or affecting the drugs composition or formulation (see 21 CFR 207.1).  
22 However, if you manufacture both the API and the finished dosage form at a single establishment, and you 
separately list the API with its own NDC, then you should include the NDC for the finished dosage form under 
MANUFACTURE and the NDC for the API under API MANUFACTURE. 
  7  Contains Nonbinding Recommendations 
 
2.  Business Operation 
 
For each establishment you identify, specify the business operation performed for each drug 
product. To simplify reporting, we have limited the types of business operations for drug 
products in finished package form to: 
  
  MANUFACTURE 
  REPACK 
  RELABEL 
  TRANSFILL 
  POSITRON EMISSION TOMOGRAPHY DRUG PRODUCTION  
 
3.  NDC 
 
To identify each drug product for which you are reporting, you should use the 10-digit NDC for 
the drug product as listed with FDA. You should provide the NDC in the appropriate format (i.e., 
using hyphens between the labeler code, the product code, and the package code). Appropriately 
formatted NDCs should have one of the following configurations: 4-4-2 (e.g.,1234-5678-90), 5-
4-1 (e.g., 12345-6789-1), 5-3-2 (e.g., 12345-678-90).23  
 
4.  Source NDC 
 
For a drug product listed under REPACK or RELABEL, you should provide the source NDC in 
the appropriate format (i.e., using hyphens between the labeler code, the product code, and the 
package code) using the 10-digit NDC assigned to the drug product received by the repacker or 
relabeler for repacking or relabeling. Appropriately formatted NDCs should have one of the 
following configurations: 4-4-2 (e.g.,1234-5678-90), 5-4-1 (e.g., 12345-6789-1), 5-3-2 (e.g., 
12345-678-90). This field is used to identify the drug product that was repacked or relabeled, so 
that FDA can avoid double counting this drug product when analyzing the data.  
 
5.  Amount Per 
 
The amount of each listed drug product manufactured for commercial distribution in a particular 
year should be organized by month. You should enter the name of each of the 12 months (i.e., 
January, February, ..., November, and December) followed by Annual Total in the CSV file.  
 
6.  Outermost Quantity Manufactured 
 
You should enter the quantity of the drug product that the establishment manufactured for 
commercial distribution during the relevant time period. We suggest that you provide this 
amount based on the relevant time period in which the drug product was released. This quantity 
should be based on the drug products outermost packaging. You should enter data into this field 
using a positive number (integer or decimal) or a zero depending on whether the drug product 
 
23 For certain minimally manipulated human cell and tissue products, you may use an alternatively formatted NDC 
approved for use by the relevant center director. 
  8  Contains Nonbinding Recommendations 
 
was manufactured during the relevant time period. For manually entered data in the portal, based 
on the monthly data provided, the system will calculate the annual sum. 
 
7.  Outermost Quantity Distributed (Non-US) 
 
If you entered Yes (in the CSV file) or clicked the checkbox (for manual entry) in the Intended 
to Fulfill 21 CFR 314.81 data element, you should enter only the amount of a listed drug product 
that the establishment manufactured for commercial distribution and distributed to the non-US 
market during the reporting period that would have been included in an annual report as required 
by 21 CFR 314.81(b)(2)(ii)(a). Because this is an alternative reporting process for drug products 
with an approved application, for the purposes of this field, you should only include the amount 
of drug product that would otherwise have been provided in the respective annual report under 
21 CFR 314.81(b)(2)(ii)(a) and provide this amount based on the relevant time period that the 
drug product was distributed. You should enter data into this field using a positive number 
(integer or decimal) or a zero depending on whether the drug product was distributed during the 
relevant time period. You should not leave it blank even for time periods when no drug product 
was distributed. For manually entered data, based on the monthly data provided, the system will 
calculate the annual sum.  
 
If you entered No (in the CSV file) or left the checkbox unchecked (for manual entry) in the 
Intended to Fulfill 21 CFR 314.81 data element, then you should leave this field blank. If a listed 
drug product is not subject to an approved application for which an annual report is required 
under 21 CFR 314.81(b)(2)(ii)(a), then you should leave this field blank. 
 
8.  Outermost Package Type 
 
You should enter the package type associated with the NDC for which you are submitting data. 
Values entered here should adhere to the FDA-recognized package types as outlined in the 
portal. 
 
9.  Innermost Quantity Manufactured 
 
You should use this field for multi-level packaged drug product only. You should enter the 
quantity of the drug product that the establishment manufactured for commercial distribution 
during the relevant time period. We suggest that you provide this amount based on the relevant 
time period in which the drug product was released. This quantity should be based on the drug 
products innermost packaging. You should enter data into this field using a positive number 
(integer only) or a zero depending on whether the drug product was manufactured during the 
relevant time period. For manually entered data in the portal, based on the monthly data 
provided, the system will calculate the annual sum. 
 
10. Innermost Quantity Distributed (Non-US) 
 
You should use this field for multi-level packaged drug products only. If you entered Yes (in 
the CSV file) or clicked the checkbox (for manual entry) in the Intended to Fulfill 21 CFR 
314.81 data element, you should enter only the amount of a listed drug product that the 
  9  Contains Nonbinding Recommendations 
 
establishment manufactured for commercial distribution and distributed to the non-US market 
during the reporting period that would have been included in an annual report as required by 21 
CFR 314.81(b)(2)(ii)(a). Because this is an alternative reporting process for drug product with an 
approved application, for the purpose of this field, you should only include the amount of drug 
products that would otherwise have provided in the respective annual report under 21 CFR 
314.81(b)(2)(ii)(a) and provide this amount based on the relevant time period in which the drug 
product was distributed. You should enter data into this field using a positive number (integer 
only) or a zero depending on whether the drug product was distributed during the relevant time 
period. You should not leave it blank even for time periods when no drug product was 
distributed. For manually entered data in the portal, based on the monthly data provided, the 
system will calculate the annual sum. 
 
If you entered No (in the CSV file) or left the checkbox unchecked (for manual entry) in the 
Intended to Fulfill 21 CFR 314.81 data element, then you should leave this field blank. If a listed 
drug product is not subject to an approved application for which an annual report is required 
under 21 CFR 314.81(b)(2)(ii)(a), then you should leave this field blank. 
 
11. Innermost Package Type 
 
You should use this field for multi-level packaged drug products only. If you are submitting 
information for a listed drug product that has multiple levels of packaging, this field should 
reflect the package type directly enclosing the drug product for which you are reporting data. 
Values entered here should adhere to the FDA-recognized package types as outlined in the 
portal.  
 
12. Intended to Fulfill 21 CFR 314.81  
 
The guidance for industry Reporting Amount of Listed Drugs and Biological Products Under 
Section 510(j)(3) of the FD&C Act explains the circumstances under which FDA does not intend 
to take action against an applicant regarding the requirement to submit distribution data in an 
annual report under section 314.81(b)(2)(ii)(a) if certain data is included in a report that is 
submitted through the portal.  
 
If the drug products application holder is not seeking to use the alternative reporting process for 
the distribution data required in an annual report under section 314.81(b)(2)(ii)(a) or a listed drug 
product is not subject to an approved application for which such an annual report is required (i.e., 
the listed drug product is not subject to an approved new drug application or an abbreviated new 
drug application), then you should enter No (in the CSV file) or leave the checkbox unchecked 
(for manual entry). If the drug products application holder is seeking to use the alternative 
reporting process for the distribution data required in an annual report under section 
314.81(b)(2)(ii)(a), then you should enter Yes (in the CSV file) or click the checkbox (for 
manual entry). 
   
  10  Contains Nonbinding Recommendations 
 
E.  Reporting Amount of Drug Products Not in Finished Package Form 
 
1.  Establishment DUNS 
 
You should include the DUNS number for each establishment covered by the submission. The 
DUNS number is a 9-digit number, including any leading zero(s), but without dashes or spaces. 
 
2.  Business Operation 
 
For each establishment you identify, specify the business operation performed for each drug 
product. To simplify the reporting, we have limited the types of business operations for drug 
products not in finished package form to:  
 
  MANUFACTURE 
  REPACK 
  RELABEL 
  TRANSFILL 
  POSITRON EMISSION TOMOGRAPHY DRUG PRODUCTION  
 
3.  NDC 
 
To identify each drug product for which you are reporting, you will use the 10-digit NDC for the 
drug product as listed with FDA. You should provide the NDC in the appropriate format (i.e., 
using hyphens between the labeler code, the product code, and the package code). Appropriately 
formatted NDCs should have one of the following configurations: 4-4-2 (e.g.,1234-5678-90), 5-
4-1 (e.g., 12345-6789-1), 5-3-2 (e.g., 12345-678-90).24  
 
4.  Source NDC 
 
For a drug product listed under REPACK or RELABEL, you should provide the source NDC in 
the appropriate format (i.e., using hyphens between the labeler code, the product code, and the 
package code) using the 10-digit NDC assigned to the drug product received by the repacker or 
relabeler for repacking or relabeling. Appropriately formatted NDCs should have one of the 
following configurations: 4-4-2 (e.g.,1234-5678-90), 5-4-1 (e.g., 12345-6789-1), 5-3-2 (e.g., 
12345-678-90). This field is used to identify the drug product that was repacked or relabeled, so 
that FDA can avoid double counting this drug product when analyzing the data.  
 
5.  Amount Per 
 
The amount of each listed drug product manufactured for commercial distribution in a particular 
year should be organized by month. You should enter the name of each of the 12 months (i.e., 
January, February, ..., November, and December) followed by Annual Total in the CSV file. 
  
 
24 For certain minimally manipulated human cell and tissue products, you may use an alternatively formatted NDC 
approved for use by the relevant center director. 
  11  Contains Nonbinding Recommendations 
 
6.  Quantity Manufactured 
 
You should enter the quantity of the drug product that the establishment manufactured for 
commercial distribution during the relevant time period. We suggest that you provide this 
amount based on the relevant time period in which the drug product was released. This quantity 
should be based on the drug products dosage form unit. You should enter data into this field 
using a positive number (integer or decimal) or a zero depending on whether the drug product 
was manufactured during the relevant time period. You should not leave it blank even for time 
periods when no drug product was manufactured. For manually entered data in the portal, based 
on the monthly data provided, the system will calculate the annual sum. 
 
7.  Quantity Distributed (Non-US) 
 
If you entered Yes (in the CSV file) or clicked the checkbox (for manual entry) in the Intended 
to Fulfill 21 CFR 314.81 data element, you should enter only the amount of a listed drug product 
that the establishment manufactured for commercial distribution and distributed to the non-US 
market during the reporting period that would have been included in an annual report as required 
by 21 CFR 314.81(b)(2)(ii)(a). Because this is an alternative reporting process for drug products 
with an approved application, for the purpose of this field, you should only include the amount of 
drug product that would otherwise have been provided in the respective annual report under 21 
CFR 314.81(b)(2)(ii)(a) and provide this amount based on the relevant time period that the drug 
product was distributed. You should enter data into this field using a positive number (integer or 
decimal) or a zero depending on whether the drug product was distributed during the relevant 
time period. You should not leave it blank even for time periods when no drug product was 
distributed. For manually entered data, based on the monthly data provided, the system will 
calculate the annual sum.  
 
If you entered No (in the CSV file) or left the checkbox unchecked (for manual entry) in the 
Intended to Fulfill 21 CFR 314.81 data element, then you should leave this field blank. If a listed 
drug product is not subject to an approved application for which an annual report is required 
under 21 CFR 314.81(b)(2)(ii)(a), then you should leave this field blank. 
 
8.  Dosage Form Units 
 
You should enter the dosage form units associated with the NDC for which you are submitting 
data. Values entered here should adhere to a list of permissible values provided in the portal. 
 
9.  Intended to Fulfill 21 CFR 314.81  
 
The guidance for industry Reporting Amount of Listed Drugs and Biological Products Under 
Section 510(j)(3) of the FD&C Act explains the circumstances under which FDA does not intend 
to take action against an applicant regarding the requirement to submit distribution data in an 
annual report under section 314.81(b)(2)(ii)(a) if certain data is included in a report that is 
submitted through the portal.  
 
  12  Contains Nonbinding Recommendations 
 
If the drug products application holder is not seeking to use the alternative reporting process for 
the distribution data required in an annual report under section 314.81(b)(2)(ii)(a) or a listed drug 
product is not subject to an approved application for which such an annual report is required (i.e., 
the listed drug product is not subject to an approved new drug application or an abbreviated new 
drug application), then you should enter No (in the CSV file) or leave the checkbox unchecked 
(for manual entry). If the drug products application holder is seeking to use the alternative 
reporting process for the distribution data required in an annual report under section 
314.81(b)(2)(ii)(a), then you should enter Yes (in the CSV file) or click the checkbox (for 
manual entry).  
 
F.  Reporting Amount of Drugs That Are Not Drug Products  
 
Drugs that are not drug products25 include drugs that consist of API alone and drugs that consist 
of API with other ingredient(s) but that are not in finished dosage form. If you manufacture 
drugs that are not drug products, you should enter the amount of drugs using the data elements 
described below. 
 
1.  Establishment DUNS 
 
You should include the DUNS number for each establishment covered by the submission. The 
DUNS number is a 9-digit number, including any leading zero(s), but without dashes or spaces. 
 
2.  Business Operation 
 
For each establishment you identify, the drugs for which you are reporting for that establishment 
will be grouped by business operation performed. To simplify the reporting, we have limited the 
types of business operations to:  
 
  MANUFACTURE 
  API MANUFACTURE 
  REPACK 
  RELABEL 
  TRANSFILL 
  POSITRON EMISSION TOMOGRAPHY DRUG PRODUCTION  
 
3.  NDC 
 
To identify each drug for which you are reporting, you will use the 10-digit NDC for the drug as 
listed with FDA. You should provide the NDC in the appropriate format (i.e., using hyphens 
between the labeler code, the product code, and the package code). Appropriately formatted 
NDCs should have one of the following configurations: 4-4-2 (e.g.,1234-5678-90), 5-4-1 (e.g., 
12345-6789-1), 5-3-2 (e.g., 12345-678-90).26    
 
25 See guidance for industry Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of 
the FD&C Act (Part III.B.5.a.) 
26 For certain minimally manipulated human cell and tissue products, you may use an alternatively formatted NDC 
approved for use by the relevant center director. 
  13  Contains Nonbinding Recommendations 
 
4.  Amount Per 
 
The amount of each listed drug manufactured for commercial distribution in a particular year 
should be organized by month. You should enter the name of each of the 12 months (i.e., 
January, February, ..., November, and December) followed by Annual Total in the CSV file. 
 
5.  Mass/Volume 
 
You should enter the quantity of drug by mass or volume. We suggest that you provide this 
amount based on the relevant time period in which the drug was released. You should enter data 
into this field using a positive number (integer or decimal) or a zero depending on whether the 
drug was manufactured during the relevant time period. You should not leave it blank even for 
time periods when no drug was manufactured. For manually entered data in the portal, based on 
the monthly data provided, the system will calculate the annual sum. 
 
6.  Unit of Measure 
 
You should enter the unit of measure for reporting the amount of each listed drug. Values 
entered here should adhere to a list of permissible values provided in the portal. 
 
7.  Activity (Unit of Measure) 
 
The guidance for industry Reporting Amount of Listed Drugs and Biological Products Under 
Section 510(j)(3) of the FD&C Act specifies that API registrants (or authorized agents) should 
also provide activity for drugs that are formulated by activity (e.g., heparin). For example, 1 mL 
of penicillin with an activity of 1,000,000 units per mL has a five times greater bactericidal effect 
than 1 mL of penicillin with an activity of 200,000 units per mL. Botulinum toxin dosages are 
also expressed in units, but 1 U of botulinum toxin of one product may not have the same 
biological effect or represent the same amount as 1 U of botulinum toxin of another product.  
 
This field should only be used by API registrants (or their authorized agents) to report activity of 
drugs. Values entered here should adhere to the units provided in the portal.  
 
8.  Average Activity  
 
This field should only be used by API registrants (or their authorized agents) to provide average 
activity information for drugs that are formulated by activity. We suggest that you provide the 
average activity from all batches based on the relevant time period in which the drug was 
released. The average activity value corresponds only to the number of batches; this is not a 
weighted average. You should enter data into this field using a positive number (integer or 
decimal) or a zero depending on whether the drug was manufactured during the relevant time 
period. For example, if four batches were manufactured in a month with activity values of 90 
U/mL, 91 U/mL, 92 U/mL, and 93 U/mL, then the average activity for that month is the sum of 
the four activity values divided by four, which is 91.5 U/mL. For reporting the annual total, you 
should use the total activity values from all batches released in a reporting year divided by the 
total number of batches.  
  14  Contains Nonbinding Recommendations 
 
9.  Minimum Activity  
 
This field should only be used by API registrants (or their authorized agents) to provide 
minimum activity information for drugs that are formulated by activity. We suggest that you 
provide the minimum activity from all batches based on the month in which the drug was 
released. You should enter data into this field using a positive number (integer or decimal) or a 
zero depending on whether the drug was manufactured during the relevant time period. For 
example, if four batches were manufactured in a month with activity values of 90 U/mL, 91 
U/mL, 92 U/mL, and 93 U/mL, respectively, then you should enter 90 U/mL as the minimum 
activity value for that month. For reporting the annual total, you should enter the minimum 
activity value from all batches released in a reporting year.  
 
V.   RESOURCES 
 
  Reference Guide for Reporting Amount of Listed Drugs and Biological Products27   
 
  Guidance for industry Reporting Amount of Listed Drugs and Biological Products Under 
Section 510(j)(3) of the FD&C Act (February 2024) 
  NextGen Portal28 
  Frequently Asked Questions web page  
o
  Technical Support 
o
  Reference Guide: Account Registration and Multi-Factor Authentication (MFA) 
o
Enrollment Process 
 
27 https://www.fda.gov/drugs/drug-shortages/coronavirus-aid-relief-and-economic-security-act-cares-act-drug-
shortage-mitigation-efforts 
28 Available at https://edm.fda.gov/ 
  15  Contains Nonbinding Recommendations 
 
APPENDIX 
 
The following examples illustrate how to submit amounts of listed drugs based on the type of drug and its packaging in different 
scenarios. 
 
Reporting Amount for Drug Products in Finished Packaged Form 
  
Example 1  Finished Dosage Form With Single-Level Packaging 
 
Drug A is listed under national drug code (NDC) 12340-567-89 with the package description in its drug listing shown in Table 1. 
 
Table 1. Drug A Package Description 
Package NDC  Package description 
12340-567-89  100 TABLET in 1 BOTTLE 
 
Scenario 1  Drug Manufactured for Commercial Distribution 
 
An establishment (in a particular month) manufactured for commercial distribution and released 2,000 bottles of Drug A. The amount 
should be entered using the fields shown in Table 2. The registrant is not seeking to use the alternative reporting process for the 
distribution data required for the annual report under 21 CFR 314.81(b)(2)(ii)(a), so the Intended to Fulfill 21 CFR 314.81 field should 
indicate No and the Outermost Quantity Distributed (Non-US) field is also left blank. In this scenario, there is no innermost 
packaging, so those fields should be left blank. 
 
Table 2. Amounts Entered if Drug A Is Manufactured for Commercial Distribution 
Outermost  Innermost 
Outermost  Outermost  Innermost  Innermost 
Quantity   Quantity  Intended to Fulfill 
NDC  Quantity  Package  Quantity  Package 
Distributed  Distributed  21 CFR 314.81 
Manufactured  Type  Manufactured  Type 
(Non-US)  (Non-US) 
12340-567-89  2000    BOTTLE        No 
 
  16  Contains Nonbinding Recommendations 
 
Scenario 2  Drug Manufactured for Commercial Distribution, and Submission Intended to Fulfill 21 CFR 314.81 
 
An establishment (in a particular month) manufactured for commercial distribution and released 1,700 bottles of Drug A. Of those 
1,700 bottles, 200 were distributed to a non-US market. If Drug A is subject to an approved application for which an annual report is 
required under 21 CFR 314.81(b)(2)(ii)(a), and the application holder is seeking to use the alternative reporting process for the 
distribution data required for the annual report under 21 CFR 314.81(b)(2)(ii)(a), then the amount should be entered using the fields 
shown in Table 3. The Intended to Fulfill 21 CFR 314.81 field should indicate Yes, and 200 should be entered into the Outermost 
Quantity Distributed (Non-US) field for the 200 bottles of Drug A that were distributed to a non-U.S. market during the relevant time 
period. In this scenario, there is no innermost packaging, so those fields should be left blank. 
 
Table 3. Amounts Entered if Drug A is Manufactured for Commercial Distribution, and the Submission is Intended to Fulfill 21 CFR 
314.81 
Outermost  Innermost 
Outermost  Innermost  Innermost  Intended to 
Quantity  Outermost  Quantity 
NDC  Quantity  Quantity  Package  Fulfill 21 CFR 
Distributed  Package Type  Distributed 
Manufactured  Manufactured  Type  314.81 
(Non-US)  (Non-US) 
12340-567-89  1700  200  BOTTLE        Yes 
 
 
Example 2  Finished Dosage Form With Multi-Level Packaging and a Single NDC 
 
Drug B is listed under NDC 12340-567-01 with the package description in its drug listing shown in Table 4. In this example, the case 
is the outermost packaging because it is the highest level of packaging assigned an NDC. The innermost packaging is the bottle, since 
it directly encloses the drug (in this case, the capsules).  
 
Table 4. Drug B Package Description 
Package NDC  Package description 
12340-567-01  96 CARTON in 1 CASE 
  5 BOTTLE in 1 CARTON 
  60 CAPSULE in 1 BOTTLE 
 
  17  Contains Nonbinding Recommendations 
 
An establishment (in a particular month) manufactured for commercial distribution and released 20 cases of Drug B. The amount 
should be entered using the fields shown in Table 5. In this scenario, the innermost packaging amount should be entered based on the 
quantities in the package description in its drug listing. The application holder is not seeking to use the alternative reporting process 
for the distribution data required for the annual report under 21 CFR 314.81(b)(2)(ii)(a), so the Intended to Fulfill 21 CFR 314.81 field 
should indicate No and the Outermost Quantity Distributed (Non-US) and Innermost Quantity Distributed (Non-US) fields are left 
blank. 
 
 
Table 5. Amounts Entered if Drug B Has a Single NDC 
Outermost  Innermost 
Outermost  Innermost  Intended to 
Quantity   Outermost  Quantity  Innermost 
NDC  Quantity  Quantity  Fulfill 21 CFR 
Distributed  Package Type  Distributed  Package Type 
Manufactured  Manufactured  314.81 
(Non-US)  (Non-US) 
12340-567-01  20    CASE  9600    BOTTLE  No 
 
Example 3  Finished Dosage Form With Multi-Level Packaging and Multiple NDCs 
 
Drug C is listed under NDC 12340-999-02 with the package description in its drug listing shown in Table 6. In this example, the 
outermost packaging should be the carton, and the innermost packaging should be the blister pack because the blister pack directly 
encloses the drug (i.e., the tablets). The pouches also have been assigned an NDC. 
 
Table 6. Drug C Package Description 
Package NDC  Package description 
12340-999-02  3 POUCH in 1 CARTON 
12340-999-01  5 BLISTER PACK in 1 POUCH 
12340-999-03  21 TABLET in 1 BLISTER PACK 
 
Scenario 1  Single Innermost Package Presentation 
 
An establishment (in a particular month) manufactured for commercial distribution and released 20 cartons of Drug C (NDC 12340-
999-02). The amount should be entered using the fields shown in Table 7. In this scenario, the innermost packaging amount should be 
  18  Contains Nonbinding Recommendations 
 
entered based on the package description in its drug listing. The application holder is not seeking to use the alternative reporting 
process for the distribution data required for the annual report under 21 CFR 314.81(b)(2)(ii)(a), so the Intended to Fulfill 21 CFR 
314.81 field should indicate No and the Outermost Quantity Distributed (Non-US) and Innermost Quantity Distributed (Non-US) 
fields are left blank.  
 
Table 7. Amounts Entered if Drug C Has a Single Innermost Package Presentation 
Outermost  Innermost 
Outermost  Innermost  Intended to 
Quantity   Outermost  Quantity  Innermost 
NDC  Quantity  Quantity  Fulfill 21 CFR 
Distributed  Package Type  Distributed  Package Type 
Manufactured  Manufactured  314.81 
(Non-US)  (Non-US) 
BLISTER 
12340-999-02  20    CARTON  300    No 
PACK 
 
Scenario 2  Multiple Innermost Package Presentations 
 
An establishment (in a particular month) manufactured for commercial distribution and released 20 cartons of Drug C (NDC 12340-
999-02) and separately manufactured for commercial distribution and released 500 pouches of Drug C (NDC 12340-999-01) on their 
own (not in cartons). The amount should be entered using the fields shown in Table 8. In this scenario, the innermost packaging 
amount should be entered based on the package description in its drug listing. The application holder is not seeking to use the 
alternative reporting process for the distribution data required for the annual report under 21 CFR 314.81(b)(2)(ii)(a), so the Intended 
to Fulfill 21 CFR 314.81 field should indicate No and the Outermost Quantity Distributed (Non-US) and Innermost Quantity 
Distributed (Non-US) fields are left blank. 
 
Table 8. Amounts Entered if Drug C Has Multiple Innermost Package Presentations 
Outermost  Innermost 
Outermost  Innermost  Intended to 
Quantity   Outermost  Quantity  Innermost 
NDC  Quantity  Quantity  Fulfill 21 CFR 
Distributed  Package Type  Distributed  Package Type 
Manufactured  Manufactured  314.81 
(Non-US)  (Non-US) 
BLISTER 
12340-999-02  20    CARTON  300    No 
PACK 
BLISTER 
12340-999-01  500    POUCH  2500    No 
PACK 
 
 
  19  Contains Nonbinding Recommendations 
 
Example 4  Kit With Multiple Components 
 
Kit X is listed under NDC 23451-999-11 with the package description in its drug listing shown in Table 9 and the parts quantities 
shown in Table 10.  
 
Table 9. Kit X Package Description 
Package NDC  Package description 
23451-999-11  1 in 1 CARTON 
 
Table 10. Kit X Parts Quantities 
Part number  Package quantity 
1  Drug 1 (1 VIAL, MULTI-DOSE) 
2  Drug 2 (1 VIAL, SINGLE-DOSE) 
3  Drug 3 (1 PACKET) 
 
An establishment (in a particular month) manufactured for commercial distribution and released 200 cartons. The amount should be 
entered using the fields shown in Table 11. For kits, the fields for innermost packaging should be left blank. The application holder is 
not seeking to use the alternative reporting process for the distribution data required for the annual report under 21 CFR 
314.81(b)(2)(ii)(a), so the Intended to Fulfill 21 CFR 314.81field should indicate No and the Outermost Quantity Distributed (Non-
US) and Innermost Quantity Distributed (Non-US) fields are left blank. 
 
Table 11. Amounts Entered for Kit X With Multiple Components 
Outermost  Innermost 
Outermost  Innermost  Intended to 
Quantity   Outermost  Quantity  Innermost 
NDC  Quantity  Quantity  Fulfill 21 CFR 
Distributed  Package Type  Distributed  Package Type 
Manufactured  Manufactured  314.81 
(Non-US)  (Non-US) 
23451-999-11  200    CARTON        No 
 
 
 
  20  Contains Nonbinding Recommendations 
 
 
Reporting Amount for Drug Products Not in Finished Packaged Form 
 
Example 5  Drug Products Not in Finished Package Form 
 
Drug D is listed under NDC 23450-678-01 with the package description in its drug listing shown in Table 12. In this example, the 
dosage form unit is tablet, and the amount reported should correspond only to the dosage form associated with the NDC assigned to 
the manufactured product, regardless of whether the product is in single- or multi-level packaging.  
 
 
Table 12. Drug D Package Description 
Package NDC  Package description 
23450-678-01  50,000 TABLET in 1 DRUM 
 
An establishment (in a particular month) manufactured for commercial distribution and released 5 drums of Drug D, four containing 
50,000 tablets and one partially-filled drum with 12,000 tablets. The amount should be entered using the fields shown in Table 13. The 
application holder is not seeking to use the alternative reporting process for the distribution data required for the annual report under 
21 CFR 314.81(b)(2)(ii)(a), so the Intended to Fulfill 21 CFR 314.81 field should indicate No and the Quantity Distributed (Non-
US) field is left blank.  
 
Table 13. Amounts Entered for Drug D  
Quantity  Intended to 
Quantity  Dosage Form 
NDC  Distributed  Fulfill 21 CFR 
Manufactured  Units 
(Non-US)  314.81 
23450-678-01  212000    TABLET  No 
  
 
   
  21  Contains Nonbinding Recommendations 
 
Reporting Amount for Drugs That Are Not Drug Products 
 
Example 6  Reporting API for Drugs That are Not Formulated by Activity 
 
Drug E is listed under NDC 23450-567-01 with the package description in its drug listing shown in Table 14. 
 
Table 14. Drug E Package Description 
Package NDC  Package description 
23450-567-01  100 kg in 1 DRUM 
 
An establishment (in a particular month) manufactured for commercial distribution and released 5 drums of Drug E, with four drums 
each containing 100 kg, and one partially-filled drum with 36.5 kg, for a total of 436.5 kg. The amount should be entered using the 
fields shown in Table 15. In this scenario, Drug E is not formulated by activity, so those fields should be left blank. 
 
Table 15. Amounts Entered for Drug E  
Unit of  Activity (Unit  Average  Minimum 
NDC  Mass/Volume 
Measure  of Measure)  Activity  Activity 
23450-567-01  436.5  kg       
 
Example 7  Reporting API for Drugs That are Formulated by Activity 
 
Drug F is listed under NDC 34560-123-01 with the package description in its drug listing shown in Table 16.  
 
Table 16. Drug E Package Description 
Package NDC  Package description 
34560-123-01  100 kg in 1 DRUM 
 
An establishment (in a particular month) manufactured for commercial distribution and released 5 drums of Drug F (e.g., heparin 
sodium). These drums contained four batches of Drug F with activity specification ranging from 90 U to 120 U. The batch size for 
drug F is 100 kg, and the establishment manufactured 4 batches of Drug F in this particular month. Three batches weigh 100 kg and 
  22  Contains Nonbinding Recommendations 
 
one batch weighs 90kg, and the activities reported for each batch are 90 U, 91 U, 92 U, and 93 U, respectively. For that month, the 
mass/volume should be 390 kg, the average activity should be 91.5 U, and the minimum activity should be 90 U. The amount should 
be entered using the fields shown in Table 17.  
 
Table 17. Amounts Entered for Drug F  
Unit of  Activity (Unit  Average  Minimum 
NDC  Mass/Volume 
Measure  of Measure)  Activity  Activity 
34560-123-01  390  kg  U  91.5  90 
 
 
  23