According to a report from Packaging Digest, the U.S. Food and Drug Administration's transition to a 12-digit National Drug Code (NDC) is forcing pharmaceutical companies to revamp their packaging lines. The shift aims to improve drug traceability and combat counterfeiting, requiring updated barcodes and labeling that accommodate the longer identifier.
The new NDC format expands the previous 10- or 11-digit codes to a standardized 12 digits, aligning with global standards like GS1. This change impacts everything from bottle labels to cartons and unit-dose packaging, as companies must ensure legibility and scannability across the supply chain. Machine vision systems and code verification processes are also being upgraded to handle the added characters without errors.
Industry experts note that compliance deadlines vary by product type, with some requiring implementation by 2025. The overhaul extends beyond mere label changes, involving software updates for inventory management and serialization systems. Packaging suppliers are advising clients to start planning now to avoid last-minute bottlenecks and disruptions in production.