---
kind: "section"
citation: "21 C.F.R. § 207.35"
title: "21"
number: "207.35"
heading: "What changes require a new NDC?"
url: "https://uscodex.org/cfr/21/207.35"
---

# §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)](#b) and [(c)](#c) of this section. A new NDC must be proposed to FDA for assignment through an updated listing in accordance with [§ 207.57](/cfr/21/207.57.md).
- (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.

## Notes

### Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 355, 360, 360b, 371, 374, 381, 393; 42 U.S.C. 262, 264, 271.

### Source

Source: 81 FR 60212, Aug. 31, 2016, unless otherwise noted.