WTO notification · TBT
United StatesAdopted, according to its latest notice
Official title
Revising the National Drug Code Format and Drug Label Barcode Requirements
The United States issued an addendum on 9 March 2026 to the earlier TBT notification G/TBT/N/USA/1899. Addenda often report that a measure was adopted, changed, postponed or withdrawn. The measure was first notified on 26 July 2022. The comment period closed on 22 November 2022.
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Published here:
Updated here:
National drug code (NDC) label barcode requirements; Technical product documentation; Pharmaceutics
Latest notice (G/TBT/N/USA/1899/Add.1, 9 March 2026)
The latest notice says the measure was adopted or published.
Revising the National Drug Code Format and Drug Label Barcode Requirements
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to standardize the format of the National Drug Code (NDC). Under this final rule, all FDA-assigned NDCs will be required to be 12 digits in length with 3 distinct segments and 1 uniform format. The first segment is a 6-digit labeler code, the second segment is a 4-digit product code, and the third segment is a 2-digit package code. Additionally, we are revising the drug product barcode label requirements to permit the use of other data carriers that meet the standards of this final rule. This rule is effective 7 March 2033. 91 Federal Register (FR) 10749, 5 March 2026; Title 21 Code of Federal Regulations (CFR) Parts 201 and 207: This final rule and the proposed rule notified as G/TBT/N/USA/1899 is identified by Docket Number FDA-2021-N-1351. The Docket Folder is available on Regulations.gov at and provides access to primary documents as well as comments received. Documents are also accessible from Regulations.gov by searching the Docket Number.
Proposed rule - The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend our regulations governing the format of the National Drug Code (NDC). The NDC is an FDA standard for uniquely identifying drug products marketed in the United States. This action, if finalized, will standardize the format of all NDCs. Specifically, all NDCs will be required to be 12 digits in length with 3 distinct segments and 1 uniform format. The first segment is the labeler code and will be 6 digits, the second segment is the product code and will be 4 digits, and the third segment is the package code and will be 2 digits. Additionally, we are proposing to revise the drug product barcode label requirements to permit the use of other data carriers that meet certain standards.
Every notice about this measure published here, newest first. Each one is the notifying member's own text.
AddendumG/TBT/N/USA/1899/Add.1
Revising the National Drug Code Format and Drug Label Barcode Requirements
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to standardize the format of the National Drug Code (NDC). Under this final rule, all FDA-assigned NDCs will be required to be 12 digits in length with 3 distinct segments and 1 uniform format. The first segment is a 6-digit labeler code, the second segment is a 4-digit product code, and the third segment is a 2-digit package code. Additionally, we are revising the drug product barcode label requirements to permit the use of other data carriers that meet the standards of this final rule. This rule is effective 7 March 2033. 91 Federal Register (FR) 10749, 5 March 2026; Title 21 Code of Federal Regulations (CFR) Parts 201 and 207: This final rule and the proposed rule notified as G/TBT/N/USA/1899 is identified by Docket Number FDA-2021-N-1351. The Docket Folder is available on Regulations.gov at and provides access to primary documents as well as comments received. Documents are also accessible from Regulations.gov by searching the Docket Number.
Regular notificationG/TBT/N/USA/1899
Comment deadline: Closed on 22 November 2022
Revising the National Drug Code Format and Drug Label Barcode Requirements
Proposed rule - The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend our regulations governing the format of the National Drug Code (NDC). The NDC is an FDA standard for uniquely identifying drug products marketed in the United States. This action, if finalized, will standardize the format of all NDCs. Specifically, all NDCs will be required to be 12 digits in length with 3 distinct segments and 1 uniform format. The first segment is the labeler code and will be 6 digits, the second segment is the product code and will be 4 digits, and the third segment is the package code and will be 2 digits. Additionally, we are proposing to revise the drug product barcode label requirements to permit the use of other data carriers that meet certain standards.
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