US to standardize drug identification with new 12-digit NDC system

USA – The US Food and Drug Administration (FDA) has announced a significant update to the National Drug Code (NDC) system, confirming that all medicines marketed in the United States will adopt a uniform 12-digit format by 7 March 2033.

The shift replaces the current 10-digit structure, which has long been a source of complexity in drug labelling, billing, and supply-chain management.

The NDC is a unique identifier linking each product to a specific manufacturer, formulation, and package configuration.

Traditionally, 10-digit NDCs have used varying segment lengths, such as 4-4-2, 5-3-2, and 5-4-1, creating challenges for electronic health records, pharmacy systems, and barcode scanning.

The FDA cites the risk of exhausting labeler codes and inconsistencies in pharmaceutical data as key drivers for standardization.

The new 12-digit NDC format establishes a consistent 6-4-2 segment structure: six digits for the labeler code, four for the product code, and two for the package code.

Existing 10-digit numbers will convert automatically through the addition of leading zeros, and drug listing records will be updated accordingly.

To ease adoption, the FDA has outlined a phased transition. From 5 March 2026 until 6 March 2033, 10-digit codes will continue to be assigned while stakeholders update systems and labels.

After 7 March 2033, all newly assigned NDCs will follow the 12-digit structure. Companies have until 6 March 2036 to complete label updates and exhaust remaining 10-digit packaging. Post-deadline, medicines with outdated codes could face regulatory enforcement.

Industry experts note that the change will require extensive coordination across pharmaceutical manufacturers, distributors, pharmacies, payers, and healthcare providers.

IT systems, packaging lines, and regulatory documentation will all need adjustments to accommodate both formats during the transition period.

Earlier this year, the FDA also implemented tighter traceability rules for biologics and high-risk drugs, reflecting a broader regulatory trend toward enhanced data standardization and supply-chain transparency.

Globally, the European Medicines Agency has encouraged similar initiatives to harmonize medicine coding and improve interoperability across borders.

With this overhaul, the US pharmaceutical sector is poised for more streamlined operations, reduced data errors, and a robust platform to manage the increasing complexity and volume of medicines entering the market.

Subscribe to our email newsletters that provide busy executives like you with the latest news insights and trends from Africa and the World. SUBSCRIBE HERE