What term describes the set of numbers or characters used to uniquely identify each package or homogenous case, comprising the NDC and a unique alphanumeric serial number up to 20 characters?

• A. SNI
• B. NDC with serial
• C. Lot number
• D. Batch name

Answer: (A)

Serialization combines the drug’s NDC with a unique serial number to create one unique identifier for every package or homogeneous case. The NDC identifies the product, but adding a distinct alphanumeric serial number (up to 20 characters) lets you distinguish each individual package. This whole construct is called the Serialized National Identifier. It supports traceability, recalls, and verification across the supply chain. The other terms refer to production groups and are not the per-package serial identifier; while “NDC with serial” describes the idea, the formal term used for the unique package identifier is Serialized National Identifier.