The FDA has issued a final rule revising the National Drug Code (NDC) format and drug label barcode requirements to adopt a uniform 12-digit standard for uniquely identifying drugs marketed in the U.S. Currently, FDA assigns 10-digit NDCs in various formats for human drugs, including biological products, and animal drugs, but this rule standardizes them without affecting non-FDA uses like the HIPAA 11-digit reimbursement format.
Implementation Timeline
The rule takes effect on March 7, 2033, when FDA will assign new 12-digit NDCs and convert all existing 10-digit ones. Until then, from March 5, 2026, to March 6, 2033, FDA will continue issuing 10-digit NDCs, giving manufacturers, distributors, repackagers, relabelers, pharmacies, health care providers, payors, and supply chain partners time to update systems and labeling.
A three-year transition period from March 7, 2033, to March 6, 2036, allows depleting old labeling stock with 10-digit NDCs, after which drugs introduced into interstate commerce bearing 10-digit NDCs may face regulatory action. Companies should add leading zeros to labeler, product, or package code segments as needed and begin using 12-digit NDCs on labels promptly after the effective date.
System and Barcode Updates
Stakeholders must prepare systems to handle both 10- and 12-digit formats during the transition, with FDA automatically updating drug listing files to the new format on March 7, 2033—no new submissions required for the change itself. Registrants should update listings once labeling reflects the 12-digit NDC.
The rule supports linear or nonlinear barcodes encoding the NDC per FDA-recognized standards like GS1, enabling a single 2D data matrix barcode to meet both NDC barcode and Drug Supply Chain Security Act (DSCSA) product identifier requirements starting March 7, 2033, including serial number, lot number, and expiration date.
Exceptions
Certain biologics, such as specified human cells, tissues, and cellular and tissue-based products, may continue using an FDA-approved alternative NDC format.
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