March 5, 2026 – Regulatory Alert: FDA Issues Final Rule on NDC Format
The rule takes effect on March 7, 2033
FDA’s final rule, Revising the National Drug Code Format and Drug Label Barcode Requirements, adopts a uniform, 12-digit format for the national drug code (NDC). The NDC is an FDA standard for uniquely identifying drugs marketed in the U.S. Currently, the NDC assigned by FDA for each listed drug marketed in the U.S. is a unique 10-digit number and can be in several different formats.
The rule takes effect on March 7, 2033. On the effective date, FDA will assign new 12-digit NDCs and convert all previously assigned 10-digit NDCs to the uniform 12-digit NDC format. This change will impact NDCs assigned by FDA to human drugs, including biological products and animal drugs. This rule affects only FDA-assigned NDCs. It does not make any changes to NDCs formats that are used for other purposes unrelated to FDA (e.g., the HIPAA standard 11-digit format used for reimbursement).
What happens during the seven-year period before the rule takes effect (March 5, 2026 – March 6, 2033)?
FDA will continue to assign 10-digit NDCs in the current formats. Manufacturers, distributors, repackagers, relabelers, pharmacies, health care providers, payors and other supply chain partners should use this time to update their systems, processes and infrastructure to handle the 12-digit NDC format by March 7, 2033.
Read the full alert Here.
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For questions regarding this regulatory alert or assistance with FDA compliance, please contact QPharma or book a meeting with a compliance expert Here.
