NDC Express
By Food and Drug Administration
Currently, drug products are recognized and reported utilizing a novel, 10-digit, three-segment number. This is known as the National Drug Code, most often referred to as the NDC quantity. The FDA assigns the first phase, the labeler code. A “labeler” is a firm that manufactures or distributes the drug, together with drug re-packagers or re-labelers. This section accommodates 4 or 5 digits. The second segment, the product code, identifies the drug, including the specific strength, dosage kind, and formulation. The third section, the bundle code, identifies package deal sizes and kinds. The agency assigns the product and bundle codes.
All drugs coming into U.S. commercial distribution are required to be listed with the FDA. Firms submit the NDCs numbers assigned to the medication they manufacture or distribute as part of their listing necessities. The FDA publishes these NDC numbers and different data submitted the net NDC Directory The assignment of an NDC quantity doesn't in any way denote FDA approval of the product.
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