National Drug Codes are unique identifiers to identify medications in the United States. Each National Drug Code, or NDC, is composed of 10 digits, broken into three segments. The Centers for Medicare & Medicaid Services (CMS) and other payers may require an NDC composed in an 11-digit format for billing and other purposes. A leading zero is added to a 10-digit code in this case.
The Three Segments of National Drug Codes
The three segments of an NDC identify the product’s labeler, the product itself, and the commercial package size.
The first segment identifies the medication’s labeler, which could be a drug manufacturer, repackager, or distributor.
The second segment features the product code, which identifies the drug’s strength, dosage form (capsule, tablet, etc.), and the labeler’s formulation.
The third and final segment is the package code, which is used to identify the package size and type.
The possible combinations of digits in an NDC are 4-4-2, 5-3-2, or 5-4-1. This means there are possibly four or five digitals for the labeler segment, three or four for the product segment, and one or two digits for the packaging segment.
The NDC Directory
The NDC Directory is updated regularly and includes all FDA-authorized human drugs available for sale in the US. If a product is not listed in the directory, it could be an over-the-counter (OTC) medication, an insulin product, or not a prescription drug.
Once a manufacturer has notified the FDA that a product is no longer commercially available, it is removed from the NDC Directory.
How TempDev Can Help With National Drug Codes
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