FDA Proposes Changes to National Drug Code Format and Barcode Requirements

The Food and Drug Administration is proposing to revise the format of the National Drug Code (NDC) and update drug label barcode requirements for drugs and biologics to standardize product identification across the health care supply chain.

The proposal would transition NDCs to a uniform 12-digit format and allow the use of both linear and non-linear barcodes on product labels. FDA said the changes are intended to expand the available pool of NDC numbers and improve interoperability among health care systems, pharmacies and supply chain stakeholders.

Comments are due May 5. Additional details are available in the Federal Register notice.