NDC Labeller code (National Drug Code)

National Drug Code (NDC Code)is a ten digit unique product identifier number for human drugs.

  • First segment (4 or 5 digits) of NDC Labeller code (NDC Code) identifies the establishment. (manufacturer, packer, labeller etc. )
  • Second segment of NDC Labeller code identifies the drug (strength, dosage and formulation)
  • Third segment of NDC Labeller code identifies the package size and package type

The second and third segments of the NDC Code are assigned by the labeller/owner.

NDC code request to FDA should submit in SPL (structured Product Labelling) format via FDA ESG (electronic submission gateway). This is important for Drug Listing

Please contact us for any registration, NDC Code or Drug Listing requirement.

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