Required formats for a DSCSA product identifier

The product identifier has both data and presentation requirements. Pharmacy staff may scan it for verification and tracing, but the required human-readable information also supports manual checks and records. Do not confuse the DSCSA's 2D barcode on a package with every barcode printed on the carton; other drug-label rules may require an additional linear barcode.

The four data elements

A product identifier combines a standardized numerical identifier, a unique serial number, the lot number, and the expiration date. The standardized numerical identifier contains the product's NDC and relevant package configuration. Together, the elements identify the product and individual package for verification and tracing through the supply chain.

Package and case are not the same level

The package is the smallest individual saleable unit that the manufacturer or repackager intends to sell to a dispenser. A homogeneous case contains identical packages with the same product identifier data for product, lot, and expiration. The barcode options differ by level: a 2D data matrix is required on a package; a homogeneous case may use a linear barcode or a 2D data matrix.

Why readable text remains useful

A scanner can capture the identifier quickly, but a pharmacist or technician may need to read or record the NDC, lot, or expiration date during receipt, verification, or an investigation. Compare the scanned data with the readable information when required by workflow. If the package is damaged, the barcode will not scan, or the displayed data conflict, quarantine or escalate it under the pharmacy's verification procedure rather than guessing.

Do not substitute one barcode rule for another

FDA explains that the DSCSA 2D data matrix requirement does not automatically replace an otherwise-required linear barcode under 21 CFR 201.25. Some packages may therefore bear both. The label's exact obligations depend on product type, packaging level, and applicable exemptions or exceptions. A pharmacy should follow its wholesaler and verification process and preserve accurate transaction records.

Exam traps

• Saying a linear barcode alone meets the DSCSA package identifier requirement.
• Confusing a case-level code with the package-level data-matrix requirement.
• Remembering the barcode but omitting the human-readable presentation.
• Listing only the NDC and forgetting serial, lot, or expiration data.
• Assuming the DSCSA data matrix eliminates a separate linear barcode requirement.

Key takeaway

At package level, remember human-readable product-identifier text plus a 2D data matrix. For a homogeneous case, the machine-readable data may use a linear barcode or a 2D data matrix. Know the four data elements and check the packaging level.