The U.S. Food and Drug Administration (FDA) guidelines for National Drug Code (NDC) submissions for co-packaged products listed as kits and multi-level packaged products are as follows:

For co-packaged products listed as kits and multi-level packaged products, providers should report the NDC on the OUTERMOST package. Only the outermost NDC is reported by firms as part of their product listing submission to the FDA and included in the NDC directory. Only NDCs included in the NDC directory will be considered valid NDCs for claims submission.

Resources

Additional information is available on the FDA’s NDC Package File Definitions webpage and on our dedicated NDC webpage.

The NDC submission guidelines for co-packaged products listed as kits and multi-level packaged products will be added to the Billing section of the Provider Manual for Participating Professional Providers and the Billing & Reimbursement for Ancillary Services section of the Hospital Manual for Participating Hospitals, Ancillary Facilities, and Ancillary Providers.