All human drug products marketed in the United States must be identified using the National Drug Code (NDC), a unique, three-segment number that serves as the universal product identifier for drugs.
Obtaining your NDC labeler code is an essential first step in bringing your pharmaceutical product to market. Each NDC consists of a 10-digit, three-segment number that identifies:
- Labeler Code (First Segment): Assigned by the FDA, this identifies your company as the manufacturer (including repackers or relabelers) or distributor of the drug under your own name.
- Product Code (Second Segment): Designated by you, this specifies your drug’s strength, dosage form, and formulation.
- Package Code (Third Segment): Also assigned by you, this indicates your package sizes and types.
NDC formats typically appear in one of three configurations: 4-4-2, 5-3-2, or 5-4-1.
Requesting a Labeler Code
To get your labeler code, you’ll need to submit structured product labeling (SPL) data through the FDA Direct Online Portal (previously known as CDER Direct). This is a critical regulatory step to ensure your products are properly listed and compliant.
How Intertek Can Help
Intertek can guide you through the entire NDC labeler code request process. We’ll help you prepare your SPL data accurately, avoid common submission errors, and secure your FDA-assigned code quickly, so you can move forward with confidence.
Take the next step, reach out to learn how Intertek can help you secure your NDC labeler code without delays.
