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HHS/FDA RIN: 0910-AI52 Publication ID: Fall 2022 
Title: Revising the National Drug Code Format and Drug Labeling Barcode Requirements 
Abstract:

The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend its regulations governing the format of the National Drug Code (NDC).  This action, if finalized, will standardize the format of all NDCs.  Specifically, all NDCs will be required to be 12 digits in length with three distinct segments.  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 bar code label requirements to permit the use of linear or non-linear barcodes that meet certain standards.

 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Long-Term Actions 
Major: Undetermined  Unfunded Mandates: State, local, or tribal governments; Private Sector 
CFR Citation: 21 CFR 201.25(c) (Revision)    21 CFR 207.33(b) (Revision)   
Legal Authority: 21 U.S.C. 321    21 U.S.C. 331    21 U.S.C. 351 to 353    21 U.S.C. 355    21 U.S.C. 358    21 U.S.C. 360    21 U.S.C. 360b    21 U.S.C. 360gg to 360ss    21 U.S.C. 371    21 U.S.C. 374    21 U.S.C. 379e    21 U.S.C. 381    21 U.S.C. 393    42 U.S.C. 216    42 U.S.C. 241    42 U.S.C. 262    42 U.S.C. 264    42 U.S.C. 271   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  07/25/2022  87 FR 44038   
NPRM Comment Period End  11/22/2022 
Final Rule  01/00/2024 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: State 
Small Entities Affected: Businesses  Federalism: Yes 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Leyla Rahjou-Esfandiary
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Avenue, Building 51, Room 2262,
Silver Spring, MD 20993
Phone:301 796-3185
Email: leyla.rahjou-esfandiary@fda.hhs.gov