Frequently Asked Questions

What is a Global Trade Item Number (GTIN)?

The Global Trade Item Number (GTIN) is the globally unique GS1 identification number used to identify "trade items" (i.e., products and services that may be priced, ordered or invoiced at any point in the supply chain). GTINs are assigned by the brand owner of the product, and are used to identify products as they move through the global supply chain to the hospital or consumer/patient. The GTIN is used to uniquely identify a product at each packaging level (e.g., a bottle of 30 tablets; a case of 100 bottles of tablets, etc.).

What is a National Drug Code (NDC)?

The National Drug Code is a 10-digit identification number established by the U.S. Food and Drug Administration (FDA) to identify drugs in accordance with Section 510 of the Federal Food, Drug and Cosmetic Act (Act), 21 U.S.C. p360. The NDC is used by the manufacturer or relabeler to electronically submit registration and drug listing information to the FDA. The NDC consists of 3 segments which specify the drug product's labeler, trade product and package size. Each NDC code uniquely identifies a specific drug having a particular dosage form, strength, and package size.

How is the GTIN different from the NDC?

The GTIN differs from the NDC in two ways: The GTIN is used to identify all types of trade items, including drugs, medical devices, consumer products outside of the healthcare sector, and non-consumer trade items across all sectors. The GTIN is used for trade items around the world. The NDC is only used to identify drugs, and only drugs subject to U.S. FDA regulation. The GTIN uniquely identifies not only the individual sale unit of packaging, but also higher level groupings such as homogeneous cases, homogeneous pallets, etc. So, for example, a 30-tablet bottle of Drug XYZ will have one GTIN, and a 12-bottle case of the same drug will have a different GTIN. The NDC only identifies the drug itself, and does not distinguish between the individual sale unit and higher level groupings.

What is the relationship between an NDC and a GTIN?

Drug trade items that have an NDC can be given a GTIN that embeds the NDC. This is a best practice. For an individual sale unit, the NDC is embedded in a GTIN-12 by combining the following elements in left-to-right order: ? The digit "3" ? The 10-digit NDC ? A check digit, computed from the previous 11 digits according to the GS1 check digit calculator
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