What is a repackaged NDC?
FDA regards repackaging as the act of taking a finished drug product from the container in which it was distributed by the original manufacturer and placing it into a different container without further manipulation of the drug.
How do I find the NDC number for my drug?
This number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. The NDC code can be found on the outside packaging of the drug. You can search with this number to find the exact drug you have.
What is a repackaged medication?
According to the FDA, pharmaceutical repackaging is “the act of removing a preparation from its original primary container and placing it into another primary container, usually of smaller size.” Pharmacies commonly repackage preparations into unit-dose configurations for patients.
What is the 11 digit NDC number lookup?
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. The 3 segments of the NDC identify: the labeler, the product, and the commercial package size.
What does the second group of numbers identify in a NDC number?
The first set of numbers in the NDC identifies the labeler (manufacturer, repackager, or distributer). 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 manufacturer.
Can a drug have more than one NDC?
Moving up to 6-digit labeler codes will expand NDCs to 11 digits and allows for two additional NDC configurations: 6-3-2 and 6-4-1, for a total of five possible NDC configurations (including the three 10-digit NDC configurations).
What do the 3 sections of the NDC code signify?
The 3 segments of the NDC identify: the labeler, the product, and the commercial package size. The first set of numbers in the NDC identifies the labeler, such as the drug manufacturer, repackager, or distributer.