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National Drug Code (NDC) Assignment & Product Code Services
The National Drug Code (NDC) is a unique identifier used by the U.S. Food and Drug Administration (FDA) to identify drug products marketed in the United States. Each NDC consists of three distinct segments that identify the labeler, product, and commercial package size.
An accurate NDC is required for FDA drug listing, regulatory compliance, and billing purposes.
Understanding the Three Segments of an NDC
An NDC identifies the following:
1. Labeler Code
The first segment of the NDC identifies the labeler, which may be the drug manufacturer, repackager, or distributor.
This code is assigned by the FDA
It consists of five digits
It uniquely identifies the company responsible for the drug product
2. Product Code
The second segment, known as the product code, identifies the specific drug for a particular labeler. This includes:
Strength
Dosage form (e.g., tablet, capsule, liquid)
Formulation
The product code is assigned by the labeler, not the FDA.
3. Package Code
The third segment, called the package code, identifies the package size and type, such as bottle count, blister packs, or unit-dose packaging.
The package code is also assigned by the labeler.
10-Digit vs. 11-Digit NDC Format
The FDA publishes NDCs in a 10-digit format. However, for billing and reimbursement purposes—such as with the Centers for Medicare & Medicaid Services (CMS)—an NDC may need to be converted to an 11-digit format by adding leading zeros.
The 11-digit format is commonly required for:
Insurance claims
Medicaid and Medicare billing
Pharmacy and healthcare systems
NDC & Product Code Assistance Services
FDA Registration Assistance provides professional support to help companies obtain and assign NDC product and package codes correctly, ensuring FDA compliance and readiness for commercial distribution.
Our services include:
NDC product code assignment
Package code creation
FDA drug listing support
Regulatory guidance for proper NDC formatting
Compliance support for CMS billing requirements
 To have FDA Registration Assistance obtain or assign an NDC Code or Product Code for your company, please contact us today.
Frequently Asked Questions (FAQ)
What is an NDC number?
An NDC is a unique identifier used by the FDA to identify drug products sold in the United States.
Who assigns the NDC segments?
Labeler Code: Assigned by the FDA
Product Code & Package Code: Assigned by the labeler
Is an NDC required for all drug products?
Yes. All drug products marketed in the U.S. must have an NDC and be properly listed with the FDA.
What is the difference between a 10-digit and 11-digit NDC?
The FDA uses a 10-digit NDC, while CMS and insurers often require an 11-digit format with leading zeros for billing.
Can FDA Registration Assistance help with NDC assignment?
Yes. FDA Registration Assistance can assist with product code assignment, package code creation, and FDA drug listing compliance.
Do NDCs need to be updated?
Yes. NDCs must be updated when there are changes to formulation, strength, dosage form, or packaging.
Contact FDA Registration Assistance
Ensure your drug products are properly identified, listed, and compliant with FDA requirements.
