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FDA Releases Draft Guidance on Numerical Drug Identifier

February 27, 2009
A product’s national drug code (NDC) plus a unique eight-digit serial number will be the FDA’s standardized numerical identifier for prescription drugs, according to a draft guidance.

The serialized NDC is a numerical identifier meant to be applied to products on the package level — considered to be the smallest saleable unit in interstate commerce — rather than at the pallet or case levels, the draft guidance says. The unique serial number would be generated by the manufacturer or repackager for each individual package.

The FDA Amendments Act charged the agency with developing a standard numerical identifier system by March 2010. The agency received 59 comments on the issue from manufacturers, wholesalers, technology vendors and other organizations. Comments are due April 16.
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