C.F.R. » Title 21 » 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

21 C.F.R. § 207.35

What changes require a new NDC?

Read at: eCFRecfr.gov CornellLII GovInfogovinfo.gov CasesGoogle Scholar

(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.

Notes of Decisions
Cited in 2 cases, 2008–2009 · leading case: Schering-Plough Healthcare Prods., Inc. v. Schwarz Pharma, Inc., 547 F. Supp. 2d 939 (E.D. Wis. 2008).
Sort: Relevance Newest Treatment
Schering-Plough Healthcare Prods., Inc. v. Schwarz Pharma, Inc., 547 F. Supp. 2d 939 (E.D. Wis. 2008). “See 21 C.F.R. § 207.35 (b). In addition, given that pharmacists who purchase the defendants’ products have “special knowledge of a class of products,” it is less likely that the defendants’ use of the statements “Rx only” and “prescription only” would be interpreted to convey…”
New England Carpenters Health Benefits Fund v. First Databank, Inc., 602 F. Supp. 2d 277 (D. Mass. 2009). “21 C.F.R. § 207.35 (b)(4)(ii) provides: When a registrant has discontinued a drug product, its product code may be reassigned to another drug product 5 years after the expiration date of the discontinued product, or, if there is no expiration date, 5 years after the last…”
Annotations are extracted automatically from the opinions in the Syfert caselaw corpus and ranked by authority, recency, and treatment. Dots show Syfertize treatment of the citing case itself.