The Global Standards One (GS1) organization sets the standards for materials tracking and traceability, barcode labeling, and supply chain data exchange for all the FDA regulated supply chains in the USA.
Shown here are some of the label formats used in FDA regulated materials tracking and traceability, which are supported by iMTATs.
UPC - Universal Product Code - shown at right - is used on most packaged products sold over-the-counter at retail establishments. The barcode includes the GS1 Prefix which uniquely identifies the labeler of the product followed by a product code issued by the labeler. |
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GTIN - Global Trade Identification Number - successor to UPC barcodes to uniquely identify any material anywhere in the Global supply chain. The GTIN (Global Trade Item Number) barcode is a standardized system used to uniquely identify trade items, products, or services globally. |
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SGTIN - Serialized Global Trade Item Number - is an extension of the GTIN (Global Trade Item Number) that adds a unique serial number to identify individual containers with a quantity of a single GTIN inside or serialized products that are individually barcoded. |
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LGTIN Lot Numbered Global Trade Item Number - is an extension of the GTIN (Global Trade Item Number) that adds a unique lot number to identify a set of containers with a quantity of a single GTIN inside each one, having a common lot number. This is used for the Produce Traceability Initiative (PTI) barcode, shown here. |
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Extended SGTIN barcode consists of an SGTIN plus lot number plus expiration date. This 2D barcode is used for tracking Pharmaceuticals according to the requirements of the Drug Supply Chain Safety Act (DSCSA). It uniquely identifies each container of drugs in the supply chain from its point of origination to when the drug is finally dispensed. |
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SSCC Serialized Shipping Container Code barcode consists of a GS1 prefix followed by a unique serial number assigned by the labeler. The combination forms a unique tracking number which enables containers containing multiple products or materials to be tracked throughout the global supply chain. |