GS1 Standards

GS1 Standards for DSCSA Product Identifier Data Elements

DSCSA defines the term “product identifier” as, “a standardized graphic that includes, in both humanreadable form and on a machine-readable data carrier that conforms to the standards developed by a widely recognized international standards development organization, the standardized numerical identifier (SNI), lot number, and expiration date of the product.”

Per this definition, a DSCSA product identifier comprises the following four data elements:

  • National Drug Code (NDC)
  • Serial number
  • Batch or lot number
  • Expiration date (When using GS1 Standards for DSCSA implementation, the NDC is represented by a Global Trade Item Number® (GTIN®))

These data elements can be encoded in a GS1 barcode using the following GS1 Application Identifiers (AIs):

1

The concatenated AI element string for encoding those four data elements appears as follows:

(01){gtin}(17){exp}(10){lot}(21){ser}

where {gtin}, {exp}, {lot} and {ser} are placeholders for the actual values.

These data elements can also be expressed within a single web URI using the GS1 Digital Link syntax. The GS1 Digital Link structure (or URI template) for expressing the four data elements in the DSCSA product identifier appears as follows:

https://other.example.com/gtin/{gtin}/lot/{lot}/ser/{ser}?exp={exp}

where {gtin}, {exp}, {lot} and {ser} are placeholders for the actual values.

EXAMPLE – Consider a product instance with the following information

GS1

This example illustrates how expiration date is encoded in GS1 barcodes and represented in the GS1 Digital Link syntax using YYMMDD per GS1 Standards. It is not illustrating how to express expiration date in human-readable presentations on drug packages and/or within systems, which often use YYYYMMDD. Together, these standardized formats enable users to encode the four DSCSA data elements in a GS1 barcode, express them in a single web URI, and translate between the two. As such, they provide the foundation for automating the verification of product identifiers using barcoded data and the GS1 Lightweight Messaging Standard. Note about “00” in the day portion of expiration date.

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