The NDC Directory is limited to all over-the-counter (OTC) medications, prescription medications, and insulin packages in the U.S. For billing or other purposes, such as with the Centers for Medicare & Medicaid Services (CMS), an NDC may also be arranged in an 11-digit format with leading zeros, if needed. Food and Drug Administration (FDA), while the product and package code are assigned by the labeler. Finally, the third set is the package code, which identifies package sizes and types.The second set of numbers is the product code, which identifies the specific strength, dosage form (i.e, capsule, tablet, liquid) and formulation of a drug for a specific labeler.The first set of numbers in the NDC identifies the labeler, such as the drug manufacturer, repackager, or distributer.The 3 segments of the NDC identify: the labeler, the product, and the commercial package size. The NDC, or National Drug Code, is a unique 10-digit or 11-digit, 3-segment number, and a universal product identifier for human drugs in the United States. Medically reviewed by Leigh Ann Anderson, PharmD.
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