2022-15414: Revising the National Drug Code Format and Drug Label Barcode Requirements
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The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend our regulations governing the format of the National Drug Code (NDC). The NDC is an FDA standard for uniquely identifying drug products marketed in the United States. This action, if finalized, will standardize the format of all NDCs. Specifically, all NDCs will be required to be 12 digits in length with 3 distinct segments and 1 uniform format. The first segment is the labeler code and will be 6 digits, the second segment is the product code and will be 4 digits, and the third segment is the package code and will be 2 digits. Additionally, we are proposing to revise the drug product barcode label requirements to permit the use of other data carriers that meet certain standards.
The agency’s own summary, as published.
What this changes
Amends 2 parts of the Code of Federal Regulations — the standing rules this notice rewrites.
Rulemaking docket
We haven’t pulled this rulemaking’s full docket yet. View docket FDA-2021-N-1351 on Regulations.gov →
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