Home / Agencies / HHS / 2026-04368
Final Rule

Revising the National Drug Code Format and Drug Label Barcode Requirements

Agency
HHS
Document Number
2026-04368
Published
March 5, 2026
Effective Date
March 7, 2033

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.

Federal Register Source

This document is published by the Office of the Federal Register, National Archives and Records Administration. Access the full regulatory text, preamble, and docket comments below.

View Full Text on FederalRegister.gov →

Opens in new tab · federalregister.gov

Frequently Asked Questions

What is the 2026-04368 Federal Register document?
Document 2026-04368 is a Final Rule published by the Department of Health and Human Services in the Federal Register on March 5, 2026, with an effective date of March 7, 2033. 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. View the original at https://www.federalregister.gov/documents/2026/03/05/2026-04368/revising-the-national-drug-code-format-and-drug-label-barcode-requirements.
Is document 2026-04368 an economically significant rule?
No. Document 2026-04368 is not classified as economically significant under Executive Order 12866. Economically significant rules require OIRA review and are estimated to have impacts of $100 million or more per year.

Other Rules from HHS

Calendar Year 2027 Home Health Prospective Payment System (HH PPS) Rate Update; Requirements for the HH Quality Reporting Program and the Expanded HH Value-Based Purchasing Model; Medicare Provider Enrollment, Durable Medical Equipment (DME), and DME, Prosthetics, Orthotics, and Supplies (DMEPOS) Policies
Proposed · Jul 2026
Reducing Bureaucracy and Burden for Children, Youth, and Family Programs
Final Rule · Jul 2026
Medical Devices; Anesthesiology Devices; Classification of the Monitor for Opioid Induced Impairment of Oxygenation
Final Rule · Jun 2026
Medical Devices; General and Plastic Surgery Devices; Classification of the Skin Patch for Treatment of Hyperhidrosis
Final Rule · Jun 2026
Medicaid Program; Community Engagement Requirement for Certain Individuals
Final Rule · Jun 2026
Medical Devices; Orthopedic Devices; Classification of the Medial Knee Implanted Shock Absorber
Final Rule · Jun 2026
View all Department of Health and Human Services rules →

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official state legislatures, IAPP, NCSL, and federal regulatory trackers. See our methodology for details. Retrieved and formatted by PlainRegWatch Editorial

Every figure on PlainRegWatch is rendered directly from state source data, no number is typed in by an editor. This page draws directly on federal and state source data, no figure is typed in by an editor. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.