{"data":{"id":"us/21-cfr-207.35","jurisdiction":"us","citation":"21 CFR 207.35","heading":"What changes require a new NDC?","body":"(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.\n(b) The proposed new NDC must include a new product code when there is a change to any of the following information:\n(1) The drug's established name or proprietary name, if any;\n(2) Any active pharmaceutical ingredient or the strength of any active pharmaceutical ingredient;\n(3) The dosage form;\n(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;\n(5) A change in the drug's intended use between human and animal; or\n(6) The drug's distinguishing characteristics such as size, shape, color, code imprint, flavor, and scoring (if any).\n(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.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER C—DRUGS: GENERAL","PART 207—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","Subpart C—National Drug Code"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"36cc0b3753e22dff02f63346321657dc9437b0e946ce638dded7ace1cb67e73a","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-207.33","next":"us/21-cfr-207.37"},"notice":"GroundRules: Original legal text. Not legal advice."}