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What is an NDC?

Each human drug product in the United States is assigned a unique 10- or 11-digit number known as the National Drug Code, or NDC.

The NDC is made up of 3 segments

  • Labeler Code: identifies the manufacturer or distributor
  • Product Code: Identifies the drug's specific strength, dosage, and formulation
  • Package code: identifies the package size and type

Current-NDC-Format

 

In most cases, there are separate NDCs for the Unit of Use (vial) and Unit of Scale (box) packaging of a medication. In the example below, the NDC ending in 11 identifies a package size of 25 vials of Fentanyl whereas the NDC ending in 09 identifies a single vial of Fentanyl. 

 

fentanyl-07

 

NDCs are added and/or updated on a daily basis in Schedule2, using the NDC Directory provided by the FDA. For more information, visit the National Drug Code Directory.