21 CFR § 207.35 - What changes require a new NDC?

---
identifier: "/us/cfr/t21/s207.35"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 207.35 - What changes require a new NDC?"
title_number: 21
title_name: "Food and Drugs"
section_number: "207.35"
section_name: "What changes require a new NDC?"
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "C"
subchapter_name: "DRUGS: GENERAL"
part_number: "207"
part_name: "REQUIREMENTS FOR FOREIGN AND DOMESTIC ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN DRUGS, INCLUDING DRUGS THAT ARE REGULATED UNDER A BIOLOGICS LICENSE APPLICATION, AND ANIMAL DRUGS, AND THE NATIONAL DRUG CODE"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 331, 351, 352, 355, 360, 360b, 371, 374, 381, 393; 42 U.S.C. 262, 264, 271."
regulatory_source: "81 FR 60212, Aug. 31, 2016, unless otherwise noted."
cfr_part: "207"
---


# 207.35 What changes require a new NDC?

(a) Once an NDC has been assigned by FDA, the registrant must propose a new and unique NDC for a drug when there is a change, after the drug is initially marketed, to any of the information identified in paragraphs (b) and (c) of this section. A new NDC must be proposed to FDA for assignment through an updated listing in accordance with § 207.57.

(b) The proposed new NDC must include a new product code when there is a change to any of the following information:

(1) The drug's established name or proprietary name, if any;

(2) Any active pharmaceutical ingredient or the strength of any active pharmaceutical ingredient;

(3) The dosage form;

(4) A change in the drug's status, between prescription and nonprescription, or for animal drugs, between prescription, nonprescription, or veterinary feed directive (VFD) status;

(5) A change in the drug's intended use between human and animal; or

(6) The drug's distinguishing characteristics such as size, shape, color, code imprint, flavor, and scoring (if any).

(c) When there is a change only to the package size or type, including the immediate unit-of-use container, if any, the proposed new NDC must include only a new package code and retain the existing product code unless all available package codes have already been combined with the existing product code in NDCs assigned by FDA.