Revising the National Drug Code Format and Drug Label Barcode Requirements
The FDA proposed revising the National Drug Code format and drug label barcode requirements to modernize pharmaceutical product identification standards.
Get stories like this in your inbox
The Daily Filing · Free · Mon–Fri
Our Take
→FDA is proposing the most significant revision to drug identification standards in decades, requiring three-segment National Drug Codes and updated barcode formats to improve tracking throughout the pharmaceutical supply chain. The standardization addresses long-standing interoperability issues between manufacturer systems and pharmacy databases.
Get stories like this in your inbox
Free daily newsletter delivering S&P 500 intelligence from 25+ data sources.
Regulatory Filing Details
Affected Sectors
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to standardize the format of the National Drug Code (NDC). Under this final rule, all FDA-assigned NDCs will be required to be 12 digits in length with 3 distinct segments and 1 uniform format. The first segment is a 6-digit labeler code, the second segment is a 4-digit product code, and the third segment is a 2-digi...