NDC & product identity

Labeler code

Definition

The first NDC segment, four or five digits, assigned by the FDA to the company that puts its name on the package.

The labeler is whoever is legally responsible for the label — the manufacturer, but equally a repackager, a relabeler or a private-label distributor. Two identical tablets made in the same plant carry different labeler codes if they are sold under different companies' labels.

Labeler codes are assigned in sequence and never reused, so an old code identifies a company that may no longer exist. That is why a discontinued NDC still resolves to a labeler name.

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 RepackagerA firm that takes a finished drug and puts it into different containers, assigning its own NDC.Definition RelabelerA firm that applies its own label to a drug manufactured by someone else, assigning its own NDC.Definition Private label distributorA retailer or wholesaler whose store-brand drugs carry its own labeler code.Definition

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Labeler code

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