On July 22, 2022, FDA announced the availability of a proposed rule, Revising the National Drug Code Format and Drug Label Barcode Requirements (Docket No. FDA-2021-N-1351), that is intended to minimize the impact of the FDA running out of ten-digit national drug codes (NDCs) by adopting a single, uniform 12-digit format for FDA-assigned NDCs.
FDA is proposing to change the NDC to 12 digits in length with three distinct and consistent segments and one uniform format. Additionally, FDA is proposing to revise the drug product barcode label requirements.
Because the Agency is running out of 10-digit NDCs, this rule, if finalized, would provide certainty and predictability to stakeholders by selecting a prespecified date for an NDC change.
NDCs are currently used across the healthcare system. Changes to the NDC would impact human and animal drug manufacturers, insurers/payors, wholesale distributors, drug databanks, pharmacies, hospitals, small clinics and healthcare practitioners, dentist offices, prisons, nursing care facilities, importers, federal agencies using the NDC, state and local governments, and other supply chain stakeholders that use FDA-assigned NDCs
Under the proposed rule, the NDC would remain a three-segment numerical code consisting of the labeler code, the product code, and the package code.
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