NDC & product identity

Product code

Definition

The second NDC segment, three or four digits, identifying one specific formulation: a given strength in a given dosage form.

The product code is assigned by the labeler, not the FDA, and is unique only within that labeler's range. Product code 4132 means nothing on its own; 0169-4132 means something.

A change of strength, dosage form or formulation requires a new product code. A change of package size does not — that is the third segment.

National Drug Code (NDC)The National Drug Code is the FDA's universal product identifier for a human drug: a three-segment number that names the labeler, the specific formulation and the package size.Definition Package codeThe third NDC segment, one or two digits, identifying a specific commercial package configuration of a product.Definition Product NDCA two-segment NDC (labeler plus product) that identifies a formulation regardless of how it is packaged.Definition

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Product code

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