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FDA Animal Drug Establishment Registration & Listing

LMG assists animal drug manufacturers with FDA establishment registration, drug listing, and NDC labeler code requests via SPL submission through the FDA Electronic Submissions Gateway.

21 CFR Part 207 CVM Regulated SPL / ESG Submission Annual Renewal

Animal drugs marketed in the United States are regulated by the FDA’s Center for Veterinary Medicine (CVM) under the Federal Food, Drug, and Cosmetic (FD&C) Act. Before an animal drug can be legally marketed in the U.S., the manufacturing establishment must be registered with the FDA and all drug products must be listed. Both registration and listing are submitted electronically in Structured Product Labeling (SPL) format via the FDA Electronic Submission Gateway (ESG).

LMG provides assistance with SPL preparation and submission for animal drug establishment registration, drug listing, and NDC labeler code requests.

Who Must Register

All manufacturers, repackers, relabelers, and salvagers must register each domestic establishment that manufactures, repacks, relabels, or salvages a drug or an animal feed bearing or containing a new animal drug, and each foreign establishment that manufactures, repacks, relabels, or salvages such a drug that is imported or offered for import into the United States.

This includes:

  • Finished animal drug dosage form manufacturers
  • Active pharmaceutical ingredient (API) manufacturers used in animal drugs
  • Contract manufacturers producing animal drugs for other companies
  • Repackers and relabelers of animal drug products
  • Manufacturers of medicated animal feeds containing new animal drugs
  • Foreign establishments exporting animal drugs to the U.S. market

Private label distributors who do not also manufacture, repack, relabel, or salvage drugs are not required to register.

Establishment Registration

Animal drug establishment registration is governed by 21 CFR Part 207. Registrations must be submitted electronically in SPL format via the FDA ESG. Key requirements include:

  • Establishment name, address, and contact information
  • All trade names used by the establishment
  • Type of operations performed (manufacturing, repacking, relabeling, salvaging)
  • A DUNS number as the Unique Facility Identifier (UFI)

Registration must be renewed annually on or before December 31 of each calendar year.

Drug Listing

Every registered animal drug establishment must submit a drug listing for all products it manufactures for U.S. commercial distribution. Drug listing is submitted in SPL format via the ESG and must be updated in June and December of each year as needed. The drug listing must include the established name, proprietary name, active ingredients, strength, dosage form, labeling information, and NDC number.

Note that entry in the NDC directory does not indicate that the FDA approved or verified the information of the drug. Assignment of an NDC number to non-drug products is strictly prohibited. Under the FD&C Act, registration or assignment of an NDC number does not denote FDA approval of the company or its products.
NDC Labeler Code Request

To assign NDC numbers to animal drug products, the labeler must first obtain an NDC labeler code from the FDA. The labeler code request is submitted as a separate SPL file via the ESG or CDER Direct Portal. The labeler code forms the first segment of every NDC assigned to the company’s animal drug products.

LMG assists with the full labeler code request process — SPL preparation, DUNS number guidance, and submission through the ESG — until the labeler code is confirmed by the FDA.

U.S. FDA Agent Requirement for Foreign Establishments

Every foreign animal drug establishment must designate a U.S. FDA Agent before registration can be completed. The U.S. Agent must reside or maintain a place of business in the United States and serve as the primary point of communication between the foreign establishment and the FDA. LMG can serve as your U.S. FDA Agent for animal drug establishment registration.

Registration Does Not Mean FDA Approval

Animal drug establishment registration and NDC assignment are notification and identification requirements — they do not constitute FDA approval or endorsement of the establishment or its drug products. Any such representation is prohibited under the FD&C Act.

How LMG Can Help
  • Animal drug establishment registration — SPL preparation and ESG submission
  • Annual establishment registration renewal
  • Drug listing SPL preparation and submission
  • NDC labeler code request — SPL preparation and ESG or CDER Direct submission
  • U.S. FDA Agent services for foreign animal drug establishments
How It Works
We manage the entire process from start to finish — so you can focus on your business.
1
Data Collection
We collect all required establishment and product data — DUNS number, operations type, NDC codes, active/inactive ingredients, and complete labeling.
2
SPL Preparation
We prepare the complete Structured Product Labeling (SPL) files in FDA-required XML format for registration, drug listing, and labeler code requests.
3
FDA Submission
We submit through the FDA Electronic Submissions Gateway (ESG) or CDER Direct Portal and confirm receipt with the FDA.
4
Monitoring & Renewal
We manage June and December drug listing updates, annual registration renewal by December 31, and respond to any FDA queries.

Frequently Asked Questions

Common questions about FDA animal drug establishment registration and listing.
Registration, drug listing, and NDC labeler code requests are all submitted electronically in SPL format via the FDA Electronic Submission Gateway (ESG) or CDER Direct Portal. Paper submissions are not accepted unless a waiver is granted.
Annually, on or before December 31 of each calendar year.
Drug listings must be updated in June and December of each year as needed to reflect any changes in marketed products.
Yes. A U.S. FDA Agent is mandatory for all foreign animal drug establishments. Registration cannot be completed without one.
No. The FDA maintains a separate animal drug product listing directory, distinct from the human drug NDC Directory.
No. Registration and NDC assignment are identification requirements only and do not constitute FDA approval or endorsement of the drug or the establishment.

Ready to Register Your Animal Drug Establishment?

LMG handles complete animal drug establishment registration, drug listing, and NDC labeler code requests — fast and accurate via SPL/ESG.

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