NDC Labeler Code
$249
Required before drug product listing in the US. We apply to FDA on your behalf and confirm your company's National Drug Code labeler segment.
What's included
- ✓ NDC Labeler Code application with FDA
- ✓ Labeler code confirmation
- ✓ Guidance on NDC product segment assignment
- ✓ Ready for use in drug product listing submissions
How It Works
Confirm your establishment registration
An NDC Labeler Code can only be obtained by an establishment already registered with FDA. If you need drug establishment registration first, that service is available separately.
We apply for your labeler code
We submit the labeler code application to FDA. The labeler code is the first 4–5 digits of the NDC number and identifies your company as the drug labeler.
Labeler code assigned
Once confirmed, you have the foundation needed to construct NDC product numbers for each of your drug products and begin drug listing submissions.
Common questions
What is an NDC Labeler Code?+
The National Drug Code (NDC) is a unique 10- or 11-digit number that identifies every drug product sold in the US. The labeler code is the first segment (4–5 digits) and identifies the company that labels the drug. FDA assigns labeler codes to registered drug establishments.
Do I need an NDC labeler code before listing my drug products?+
Yes. Before you can list individual drug products with FDA, your establishment must have an NDC Labeler Code. The labeler code forms the first segment of each product's full NDC number.
Is an NDC labeler code the same as an NDC number?+
No. The NDC labeler code identifies your company. Each individual drug product then receives a full NDC number built from your labeler code plus product-specific segments. The drug listing service covers the per-product NDC filings.
Can I get an NDC labeler code without drug establishment registration?+
No. You must be registered as a drug establishment before FDA will issue an NDC Labeler Code. The Drug Full Setup bundle ($799) includes FEI acquisition, drug establishment registration, and US Agent — the prerequisites for the labeler code.
Related Articles
What Is an NDC Number and How Foreign Drug Manufacturers Obtain One
May 5, 2026
The NDC number is the product identifier for all drugs sold in the US. Here is how the system works and how foreign manufacturers get their labeler code.
FDA Drug Establishment Registration: What Foreign Manufacturers Must File
May 8, 2026
A guide to drug establishment registration under 21 CFR Part 207 for foreign pharmaceutical manufacturers entering the US market.
FDA Drug Labeling Requirements: What Foreign Manufacturers Must Include on US Packaging
May 2, 2026
US drug labeling requirements for foreign manufacturers — what must appear on packaging and how NDC numbers are formatted on labels.
Need the full drug setup including NDC?
The Drug Full Setup + Listings bundle ($1,399) includes FEI, drug establishment registration, NDC Labeler Code, US Agent, and 5 drug listings — everything a new foreign drug manufacturer needs.