U.S. FDA registration & U.S. Agent services · Casper, Wyoming, USA info@regovant.com+1 307-301-7465
Regovant LLCFDA Registration & U.S. Agent
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FDA Drug Establishment Registration, NDC Labeler Code & Listing

We register your drug establishment with FDA, obtain your NDC labeler code, list your products, and act as your U.S. Agent. Fixed prices, filed electronically in FDA's SPL format.

  • Registration, labeler code and U.S. Agent service: $369 a year
  • Drug listing with NDC: $169 per product
  • OTC and prescription drugs, API and finished dosage
Ask a question

Drug pricing

USD
Registration + labeler code + U.S. AgentPer establishment, per year$369
Drug listingPer product$169
Drug label reviewPer product$369
Drug Master File + U.S. AgentPer year$369
FDA facility fees may applySee below

Who must register?

Under 21 CFR Part 207, establishments that manufacture, repack, relabel or salvage drugs for the U.S. market must register with FDA and list every drug they make. That includes active pharmaceutical ingredient (API) makers, finished dosage manufacturers, contract manufacturers, repackers and relabelers, in the U.S. and abroad. Foreign establishments must name a U.S. Agent.

Registration is renewed every year between October 1 and December 31. Registrations and listings are submitted electronically in FDA's Structured Product Labeling (SPL) format, and each establishment needs a D-U-N-S number.

Registration is not approval

Registering an establishment and listing a product does not mean FDA has approved the drug. Before a drug can be sold in the U.S.:

  • OTC drugs must meet an FDA OTC monograph or have an approved application.
  • Prescription drugs need an approved application (NDA or ANDA).

We check which path applies to your product before listing it. If you're not sure, ask us before you order.

FDA facility fees

Some drug facilities also pay annual fees directly to FDA. OTC monograph drug facilities pay an OMUFA facility fee, and facilities making generic drugs or their APIs pay GDUFA fees. These are set by FDA each year and are not part of our price. We tell you if your facility is affected.

What's included

  • Establishment registration in SPL format
  • NDC labeler code request, if you don't have one
  • U.S. Agent service for one year for establishments outside the U.S.
  • Check of the regulatory path (monograph or application) before listing
  • Your registration details and a Regovant certificate of registration you can verify online
  • A reminder before the October–December renewal window

How it works

  1. Order online for the registration and each product to be listed.
  2. Send your details using our registration form: business operations, D-U-N-S number and product list.
  3. We prepare and submit the registration, labeler code request and listings.
  4. You receive confirmation with your labeler code and NDC numbers.

Questions

What is an NDC labeler code?

It's the first part of a National Drug Code (NDC). It identifies the company named on the label. FDA assigns it, and you then give each product and package its own NDC.

Does a contract manufacturer need its own registration?

Yes. Each establishment that manufactures, repacks or relabels the drug must register, including contract manufacturers.

Do API manufacturers need to register?

Yes. Manufacturers of active pharmaceutical ingredients for U.S. drugs must register and list.

When do I renew?

Every year between October 1 and December 31. Listings are also reviewed and updated as products change.