USA: Revising the National Drug Code Format and Drug Label Barcode Requirements
Updated on : 15-03-2026
| 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 https://www.govinfo.gov/content/pkg/FR-2026-03-05/html/2026-04368.htm https://www.govinfo.gov/content/pkg/FR-2026-03-05/pdf/2026-04368.pdfThis 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 https://www.regulations.gov/docket/FDA-2021-N-1351/document and provides access to primary documents as well as comments received. Documents are also accessible from Regulations.gov by searching the Docket Number. |
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