Revising the National Drug Code Format and Drug Label Barcode Requirements
fda-drug · Food and Drug Administration · Rule · Published 2026-03-05 · Effective 2033-03-07 · 91 FR 10749
Document
Document number
2026-04368
Federal Register citation
91 FR 10749
CFR reference
21 CFR 201
Type
Rule
Action
Final rule.
Category
fda-drug
Sub-agency
Food and Drug Administration
Publication date
2026-03-05
Effective date
2033-03-07
HHS docket
Docket No. FDA-2021-N-1351
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-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.