Beginning March 7, 2033, the Food and Drug Administration will begin assigning a 6-digit labeler code and require NDCs to have a standard 6-4-2 digits format. FDA is also giving labelers (e.g. manufacturers or repackagers) flexibility to use linear or 2D barcodes. Companies, including pharmacies, that rely on NDCs have seven years to develop, update, and test systems to handle the new NDC number format. A three-year transition period will allow for continuity and depletion of legitimate product with a 10-digit NDC on the label.
Without this rule, it is estimated that FDA would run out of 5-digit labeler codes as soon as 2036. NCPA submitted comments supporting the proposed rule.
NCPA
