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The DSCSA mandates full supply chain traceability for prescription drugs dispensed in the US. Serialization data contained on product labeling and packaging must be both machine and human readable and include its National Drug Code (NDC) and Standardized Numerical Identification (SNI) being the serial number plus lot number and expiry date. A 2D data matrix is required on all packages whilst cases can carry either a linear or 2D barcode. Kallik minimizes the impact of staying compliant with current and forthcoming pharmaceutical regulations.

How does Kallik help with the DSCSA?

Kallik helps medical device manufacturers ensure their products are correctly labeled in accordance with both the FDA’s DSCSA and global serialization requirements for device identification, manufacturer, safety and re-use requirements.


• One global platform that manages product and production data, enhancing transparency and traceability


• Maintains consistency and compliance by using a single source of labeling ‘truth’ for all market-facing products


• Improves surveillance of label and content formats to guarantee consistent communication across the diverse product portfolios and differing distribution channels

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