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 company role
We identify the company that will market the drug under its labeler code and the establishments that actually manufacture, repack, relabel, or salvage it. A private-label distributor does not automatically register its own establishment when it performs none of those activities.
Request the labeler code
We prepare the FDA labeler-code request in SPL format for the marketing company. FDA currently assigns 10-digit NDCs with 4- or 5-digit labeler segments, depending on the configuration.
Confirm the assigned code
After FDA assigns the code, a follow-up labeler-code SPL confirms it. Products cannot be listed under the assigned code until this confirmation step is complete; product listings are a separate service.
Common questions
What is an NDC Labeler Code?+
An FDA-assigned NDC currently has 10 digits in a labeler-product-package configuration. Its labeler segment identifies the company marketing the drug and currently contains 4 or 5 digits. 21 CFR 207.33 also permits 11-digit NDC configurations with a 6-digit labeler segment; FDA says it will issue those when five-digit codes are exhausted. The 11-digit HIPAA reimbursement format is separate. FDA's uniform 12-digit NDC rule takes effect March 7, 2033.
Do I need an NDC labeler code before listing my drug products?+
The marketing company needs an assigned and confirmed labeler code before listing a drug under that code. Establishments performing registrable manufacturing, repacking, relabeling, or salvaging activities have separate registration duties.
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?+
Yes, depending on your role. A private-label distributor that does not manufacture, repack, relabel, or salvage drugs does not automatically need its own establishment registration to request a labeler code. We check the responsible manufacturing establishments and the proposed marketing arrangement. The $249 standalone code service does not require buying the $799 Full Setup package.
Related Articles
What Is an NDC Number and How Foreign Drug Manufacturers Obtain One
May 5, 2026
Current NDC formats, company and establishment roles, the second confirmation SPL, and separate product listing.
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
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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.