What is the Origin of National Drug Classification?

The NDC system originated with the passage of the Drug Listing Act of 1972, which mandated that all registered drug establishments provide the Food and Drug Administration (FDA) with a current list of all commercially distributed drug products. The establishment of this standardized coding scheme was driven by the need for regulatory oversight, efficient drug tracking, and accurate reporting of medications across the entire healthcare ecosystem. NDC is a purely administrative and regulatory designation.

What is the Mechanism of National Drug Classification?

The NDC is a 10- or 11-digit code broken into three segments: the labeler code (4-6 digits), assigned by the FDA, which identifies the manufacturer or distributor; the product code (3-4 digits), assigned by the labeler, which specifies the drug's strength, dosage form, and formulation; and the package code (1-2 digits), also assigned by the labeler, which identifies the package size and type. This hierarchical structure allows the code to serve as a precise fingerprint for a specific drug product, enabling accurate inventory control, billing claims, and electronic health record integration.

National Drug Classification ∞ Area

National Drug Classification

Meaning

National Drug Classification (NDC) refers to the standardized, unique, three-segment numerical identifier assigned to every drug product intended for human use marketed in the United States. This code is a universal product identifier that provides a consistent means of identifying the manufacturer, the specific product formulation, and the trade package size of a medication. It is a mandatory requirement for drug listing and is critical for regulatory compliance, billing, and supply chain management.

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How Do Varying National Drug Classifications Affect Clinical Trial Patient Recruitment?

Varying drug classifications create distinct regulatory pathways that directly shape the eligibility and composition of clinical trial patient populations.

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HRTioJuly 26, 2025

National Drug Classification

Meaning

Origin

Mechanism

How Do Varying National Drug Classifications Affect Clinical Trial Patient Recruitment?

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