GTIN Frequently Asked Questions
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.).
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. §360. The NDC is used by the manufacturer or relabeler to electronically submit registration and drug listing information to the U.S 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.
Occasionally, an NDC appears in an 11-digit format, especially in the context of processing reimbursement claims. This FAQ discusses the NDC in the context of identifying pharmaceuticals for DSCSA reporting, and in particular the NDC as embedded in the GTIN, and for these purposes the 10-digit format is always used. 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.
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.
A GTIN that is assigned for an individual sale unit has 12 digits and is called a GTIN-12. This allows it to be carried in a UPC-A barcode, the usual barcode that is scanned at point-of-sale in North America. A GTIN that is assigned for a higher-level grouping such as a homogeneous case, homogeneous pallet, etc., has 14 digits and is called a GTIN-14. The first digit of such a GTIN is a digit between and 8 (inclusive) and is called the indicator digit. These are the two lengths of GTIN that are used for U.S. pharmaceuticals, where the NDC is embedded in the GTIN. (There are also 8-digit and 13-digit GTINs that are used for individual sale units, primarily by non-U.S. manufacturers, but a GTIN that embeds an NDC code is never a GTIN-8 or GTIN-13.
However, when a GTIN is carried in a GS1-128, GS1 DataMatrix, GS1 DataBar®, or GS1 QR barcode, it is always represented as 14 digits. A GTIN-12 is padded by adding two zero digits to the left to make 14 digits, when it is carried in these barcodes. The same is true when GTINs are stored in databases: both GTIN-12 and GTIN-14 are stored as 14 digits, with the GTIN-12 padded on the left with two zero digits. The only context in which a GTIN-12 appears as only 12 digits is in a UPC-A barcode. For this reason, it is easiest to think of a GTIN as always having 14 digits, even though for an individual sale unit it is really 12 digits preceded by two zero “filler” digits.
Yes. The GTIN is what enables you to use your NDC in GS1 barcodes including the U.P.C. barcode and GS1 DataMatrix, as well as to use the NDC in GS1 data sharing standards including EPCIS. For each drug identified by an NDC, you will create a GTIN for the corresponding individual sale unit.
Yes. All GTINs are built from a GS1 Company Prefix, and a GTIN that embeds an NDC is no exception. You will need to request to license your 03 GS1 Company Prefix which embeds your NDC labeler code.
No. GS1 US does not require you to register individual GTINs with GS1 US. You have to license a GS1 Company Prefix from GS1 US and GS1 US will maintain a record of that.
The U.S FDA already requires that NDCs be registered with the U.S. FDA. The DSCSA does not require any additional registration of the NDC beyond that already required, nor do GTINs need to be registered with the U.S. FDA.
The DSCSA does require reporting of transaction information data exchange when ownership of individual instances of drugs are transferred in the supply chain, and GTINs are used as part of this reporting when GS1 data sharing standards (EPCIS) are used.