FDA Guidance Specifies SNIs to Be Used on Drug Packages

Drugmakers will have more leeway for serial numbers on packaging that would help authenticate prescription drugs in the supply chain, according to the FDA’s first final guidance on standardized numerical identifiers (SNIs).

 The SNI will include the product’s national drug code (NDC) plus a recommended serial number of as many as 20 characters, lengthening the serial number from the one suggested in the draft guidance to accommodate high-volume products and allowing letters to be used in the sequence.

Manufacturer comments led to the change from an eight-digit serial number proposed in the January 2009 draft.
Drug GMP Report