NDC & product identity

Product NDC

Definition

A two-segment NDC (labeler plus product) that identifies a formulation regardless of how it is packaged.

0169-4132 is a product NDC. It says which company and which formulation, and nothing about package size. FDA listing files and drug databases are organised around product NDCs.

A product NDC is not billable. Claims require the package-level code, because reimbursement depends on how much drug was in the container that was opened.

Package NDCA three-segment NDC identifying an exact commercial package — the form that belongs on a claim.Definition 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 Product codeThe second NDC segment, three or four digits, identifying one specific formulation: a given strength in a given dosage form.Definition

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10-digit NDC 11-digit NDC 4-4-2 format 5-3-2 format 5-4-1 format 5-4-2 format Kit (NDC)Labeler code

All 153 terms Coding guide J-code directory

Product NDC

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