Product identifier applied per FDA guidance
Ergopharm export cartons now carry a DSCSA-format product identifier, encoding a GTIN, unique serial number, lot number and expiry date in a GS1 DataMatrix. The change aligns our labelling with the FDA's product-identifier guidance, published on 19 September 2018.
The Drug Supply Chain Security Act (DSCSA) was signed into US law on 27 November 2013 as Title II of the Drug Quality and Security Act. It establishes a phased framework for interoperable, electronic tracing of prescription medicines through the supply chain. A central element is the product identifier: a standardised code, in both human-readable text and a 2D data-matrix barcode, applied to the smallest saleable unit and to homogeneous cases. On 19 September 2018 the FDA issued its guidance on the product identifier, clarifying how manufacturers should format and apply it under the Act.
“Every carton now carries a unique, machine-readable identity, verified in line before release.”
Ergopharm has aligned its own carton artwork and serialisation processes to this format. Each unit carton is now marked with a GS1 DataMatrix (ECC200) encoding four elements identified by GS1 Application Identifiers: the GTIN under AI (01), expiry date under AI (17), batch or lot number under AI (10), and a unique serial number under AI (21). The same four data points appear in human-readable text on the carton. Together the GTIN and serial number form the standardised numerical identifier (the SGTIN) that makes each pack individually distinguishable.
The identifier is applied and verified in line at our Vadodara facility. Serial numbers are provisioned from a controlled range, printed, and read back by camera-based verification before a pack proceeds; unreadable or non-conforming codes are rejected. Case-level marking uses an SSCC under AI (00), and the parent-child relationship between packs and cases is recorded as aggregation data, so that a scanned case resolves to the serials it contains. Printed and verified data are retained under our data-integrity controls, consistent with ALCOA+ principles.
This is a change to Ergopharm's own packaging and record-keeping to meet the DSCSA data format described in the September 2018 guidance. It is not, and should not be read as, any national marketing approval. Where product is destined for markets with their own serialisation requirements, the same GS1 DataMatrix carrier and application-identifier structure provide a common technical foundation that Ergopharm configures to the destination market's rules.
Key facts
- FDA product-identifier guidance
- Issued 19 September 2018
- Legal basis
- DSCSA, signed 27 November 2013 (Title II, DQSA, PL 113-54)
- Encoded data (GS1 AIs)
- GTIN (01), expiry (17), lot (10), serial (21) in a DataMatrix ECC200
- Aggregation
- Pack = SGTIN; case = SSCC (00), linked by recorded parent-child data
This notice describes Ergopharm’s own packaging and processes and how they follow published standards; it does not assert a specific national marketing approval.