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Federal RegisterGuidance and regulationPublished March 5, 2026

Revising the National Drug Code Format and Drug Label Barcode Requirements

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-digit package code. Additionally, we are revising the drug product barcode label requirements to permit the use of other data carriers that meet the standards of this final rule.

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Tags
HIPAA, Rule, Health and Human Services Department, Food and Drug Administration
Related exam domains
CISSP 1: Security and Risk Management; CISSP 8: Software Development Security
Source record id
2026-04368
First seen by InfoSec Signals
9/23/2026

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