§ 207.35. What changes require a new NDC?
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/us/cfr/t21/s§ 207.35·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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.
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§ 207.35
What changes require a new NDC?
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