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FDA’s Proposed Change to NDC: Comments Due Nov. 22, 2022

The NDC proposal is intended to minimize the impact of “running out of ten-digit national drug codes (NDCs) by adopting a single, uniform 12-digit format for FDA-assigned NDCs.”

Proposed NDC segments and formats. Source: FDA
Proposed NDC segments and formats. Source: FDA

In July 2022, the FDA announced a proposed rule, Revising the National Drug Code Format and Drug Label Barcode Requirements.

National drug codes (NDCs) are standards for identifying drugs marketed in the U.S, composed of a labeler code, product code, and package code. FDA is proposing to change the NDC to 12 digits in length with three distinct and consistent segments and one uniform format. 

Current NDC segments and formats. Source: FDACurrent NDC segments and formats. Source: FDA

As the Agency explains, the NDC proposal is intended to minimize the impact of “running out of ten-digit national drug codes (NDCs) by adopting a single, uniform 12-digit format for FDA-assigned NDCs.” FDA has approximately 10 to 15 years of available 5-digit labeler codes if they maintain an assignment rate of 1400 to 1800 labeler codes per year.


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