Drug DUNS Number
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FDA drug establishment registration submissions include the establishment’s DUNS number, and drug listing submissions identify each manufacturing establishment by name and DUNS number. Labeler Code requests also include the company’s DUNS. We help obtain and verify the correct location-specific DUNS before your FDA drug filing.
What Is a DUNS Number and Where Does FDA Use It?
A DUNS Number is a 9-digit business-location identifier assigned by Dun & Bradstreet. For FDA drug establishment registration, FDA instructs establishments to include the name and DUNS number of the establishment itself—not a DUNS linked only to a corporate headquarters.
DUNS information also appears elsewhere in FDA drug registration and listing. Labeler Code requests include the company’s DUNS, and drug product listings include the name and DUNS number for each establishment involved in manufacturing the product.
- Drug establishment registration: location-specific establishment DUNS
- Foreign establishment registration: U.S. Agent name and DUNS, plus importer information
- Labeler Code request: company DUNS included with the request
- Drug listing: name and DUNS for each manufacturing establishment
Important: A DUNS number is an identifier used in FDA drug registration/listing data. It is not an FDA approval, registration certificate, or NDC.
Drug DUNS Request & FDA Filing Readiness Services
We coordinate the DUNS request, verify the exact business location data, and prepare the identifier for use in FDA drug registration and listing submissions.
DUNS Request Assistance
We prepare the DUNS request using the facility’s legal name, physical address, and business details, then coordinate the request with Dun & Bradstreet.
Facility Name & Address Verification
We check that the assigned DUNS corresponds to the exact establishment location you intend to use in FDA drug registration—not only a headquarters or parent-company location.
FDA Filing Readiness
We review the DUNS information against the data needed for Drug Establishment Registration, Labeler Code requests, and drug listing submissions before you file.
Update & Correction Support
If your legal name, physical address, or DUNS record changes, we help coordinate the record correction and the related FDA registration/listing update.
Drug DUNS Assistance at a Glance
Clear pricing, location-specific verification, and practical support for the FDA drug filing that comes next.
How Our Drug DUNS Request Service Works
A four-step process designed to get the correct location identifier ready before your FDA drug submission.
Submit Facility Information
Provide the exact legal business name, physical establishment address, contact information, and basic business details.
DUNS Request & Record Search
We check for an existing location record and coordinate a new DUNS request or correction when needed.
Location Data Verified
We confirm the DUNS corresponds to the facility or company record required for the intended FDA drug submission.
Ready for FDA Filing
We provide the verified DUNS information and can coordinate the next Drug Establishment Registration, Labeler Code, or drug listing step.
Complete the FDA Drug Registration Process
After your DUNS is ready, these are the most common next steps for FDA drug registration and listing.
Drug Establishment Registration
Register a domestic or foreign drug manufacturing, repacking, relabeling, or salvaging establishment with FDA.
Labeler Code Registration
Request the FDA Labeler Code used to construct NDCs before listing drug products for the first time.
NDC Code / Product Code
Prepare and submit FDA drug listing data, including the proposed NDC and manufacturing establishment information.
Drug U.S. Agent Services
Annual U.S. Agent representation for foreign drug establishments, including FDA communications and registration support.
Frequently Asked Questions About Drug DUNS Numbers
Direct answers about DUNS identifiers, FDA drug registration, Labeler Code requests, drug listings, timing, and fees.
What is a DUNS Number and why does FDA use it?
A DUNS Number is a 9-digit identifier assigned by Dun & Bradstreet to a business location or organization record. FDA drug establishment registration instructions call for the establishment’s name and DUNS number, and FDA also uses DUNS information in Labeler Code requests and drug listing data.
Who needs a DUNS Number for FDA drug registration and listing?
A drug establishment that is required to register with FDA should use the DUNS for that establishment location. A company requesting a Labeler Code includes its company DUNS, and drug listings include the name and DUNS number for each establishment involved in manufacturing the product.
What happens if I do not have the correct DUNS Number?
A missing or incorrect DUNS can prevent registration, Labeler Code, or drug listing data from being prepared or validated correctly and can delay the filing. The safest approach is to verify the location record before the FDA submission.
Does a DUNS Number replace my FDA Drug Establishment Registration?
No. A DUNS Number identifies the business or establishment location. FDA Drug Establishment Registration is a separate regulatory filing. A DUNS number does not by itself mean that an establishment is registered with FDA.
Does each physical drug establishment location need its own DUNS Number?
FDA’s drug establishment registration instructions specify the DUNS number of the establishment, not one linked only to corporate headquarters. When a company operates multiple distinct establishment locations, each location should be represented by the DUNS associated with that physical establishment.
Can a foreign drug establishment obtain a DUNS Number?
Yes. Foreign establishments can obtain DUNS numbers. Foreign drug establishment registrations also include the name and DUNS of the U.S. Agent and information about importers, so the correct identifiers should be coordinated before filing.
How does FDA Registration Assistance obtain or verify my DUNS Number?
We review the exact legal name and physical address, search for an existing Dun & Bradstreet record, coordinate a new request or correction when needed, and verify the resulting DUNS for the intended FDA drug submission.
What information is needed to request a DUNS Number?
Typically we begin with the legal business name, physical address, contact information, and basic business details for the location. Dun & Bradstreet may request additional information depending on the company and country.
Why must the DUNS information match my FDA drug filing?
FDA uses the DUNS to identify the establishment or company record referenced in registration and listing data. Using a headquarters DUNS, an outdated address, or a mismatched legal name can create validation problems and delay the submission.
Is a DUNS Number used for an FDA Labeler Code request?
Yes. FDA’s current Labeler Code instructions state that the request includes necessary data such as the company name and DUNS number, along with contact information for the person responsible for drug listings under that labeler code.
How long does Drug DUNS Request Assistance take?
Our typical service target is 3–5 business days when the business location can be validated promptly. Actual DUNS assignment or record-correction timing is controlled by Dun & Bradstreet and can vary by company, country, and verification requirements.
How much does Drug DUNS Request Assistance cost?
Our professional Drug DUNS Request Assistance fee is $399 USD one time. This is a professional service fee for request preparation, coordination, verification, and FDA filing readiness; it is not an FDA government fee.
Do I need to update my DUNS record if my facility information changes?
Yes. If the legal name or physical location information changes, the Dun & Bradstreet record should be reviewed and updated as needed. The related FDA establishment registration or listing data may also need to be updated.
Can you help if an FDA filing has a DUNS mismatch or validation problem?
Yes. We can review the DUNS and location information, identify likely mismatches, coordinate a Dun & Bradstreet correction when appropriate, and assist with the related FDA drug registration or listing update.
Is a DUNS Number used in FDA drug listing submissions?
Yes. FDA’s current drug listing instructions require the name and DUNS number for each establishment involved in manufacturing the product.
Can FDA Registration Assistance handle the DUNS Number and the full drug registration process?
Yes. We can coordinate DUNS Request Assistance with Drug Establishment Registration, Labeler Code Registration, NDC/drug listing services, and annual U.S. Agent representation for foreign drug establishments.
Request Drug DUNS Assistance
Send the exact business or facility information you want to use for FDA drug registration. We’ll review the location record and contact you about the DUNS request or verification.
Thank You for Reaching Out!
We received your inquiry. A member of our team will review the facility information and follow up. For immediate assistance, call 928-275-8333.