FDA Proposes to Move to 12-digit National Drug Codes

FDA has made available a proposed rule on Revising the National Drug Code Format and Drug Label Barcode Requirements (Docket No. FDA-2021-N-1351) that outlines the agency’s adoption of 12-digit format for national drug codes (NDCs). The agency says it is running out of 10-digit NDCs and the 12-digit code will include “three distinct and consistent segments and one uniform format.” Additionally, FDA is proposing to revise the drug product barcode label requirements.

The agency notes that because NDCs are currently used across the healthcare system, changes to their format 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, state and local governments, and other supply chain stakeholders.