Pharmaceutical companies are facing a significant packaging overhaul as the U.S. Food and Drug Administration transitions from the current 10-digit National Drug Code (NDC) to a 12-digit format, according to a report from Packaging Digest. The change, which aims to align with global standards and improve drug traceability, requires manufacturers to update labels, barcodes, and packaging systems to accommodate the additional two digits.
Industry experts warn that the transition involves rigorous compliance timelines and significant costs for reprinting labels, reprogramming packaging software, and retesting barcode readability. The new NDC format will affect all prescription drug packages, including vials, bottles, and blister packs, necessitating changes in both primary and secondary packaging.
The move is part of broader efforts to enhance drug supply chain security under the Drug Supply Chain Security Act (DSCA). Companies must ensure their updated NDCs are encoded in GS1-128 barcodes or DataMatrix codes, requiring coordination with packaging suppliers, printers, and IT teams to avoid compliance gaps.