An FDA labeler code identifies the company marketing a drug. Generally, only manufacturers and distributors that need to list drugs with FDA should request one. The request is submitted electronically as a Structured Product Labeling (SPL) document through FDA Direct or an approved submission route. Before requesting a code, prepare the company name, DUNS number, and a responsible contact for FDA communications. A labeler code is required before a company can list a drug or reserve a National Drug Code (NDC), but it does not by itself authorize commercial sale, prove product approval, or satisfy establishment registration requirements.
What an FDA Labeler Code Actually Identifies
According to FDA’s instructions, labeler codes are used to propose and assign National Drug Codes (NDCs) for drugs and are required prior to listing a drug or reserving an NDC for the first time. The labeler code identifies the company marketing the drug. Critically, a separate labeler code is not required for each establishment manufacturing the drug; a manufacturer with multiple establishments can use one labeler code for all establishments. Generally, only drug manufacturers and distributors need a labeler code, and a company that does not manufacture or distribute drugs in the U.S. should not apply for one.
FDA states that a separate labeler code is not required for each establishment manufacturing the drug. A manufacturer with multiple establishments can use one labeler code for those establishments. For a broader view of how labeler codes fit into the registration and listing landscape, see the FDA drug registration and listing compliance map.
Pre-Request Checklist for Foreign Companies
The table below consolidates every input and action a foreign company should prepare before submitting a labeler code request. Each row maps to a specific step described on FDA’s “How to Request a Labeler Code” page.
| Step | Checklist Item | What to Prepare | Key Detail |
|---|---|---|---|
| 1 | Obtain a DUNS number | A valid Data Universal Numbering System (DUNS) number assigned to the company by Dun & Bradstreet | The SPL request must include the company name, DUNS number, and contact information; aligning legal name and address with the DUNS record is editorial advice, not an FDA exact-match requirement |
| 2 | Confirm company legal name and address | Registered legal name, physical address, and contact information for someone responsible for receiving FDA communications | Aligning company name and address with the DUNS record is editorial advice for internal consistency, not an FDA-mandated exact-match requirement |
| 3 | Designate a responsible contact | Name, email, and phone of an individual who will receive FDA communications related to drug listings with NDCs under that labeler code | This contact must be reachable for FDA correspondence about drug listings under the labeler code |
| 4 | Create the labeler code request SPL document | A Structured Product Labeling (SPL) XML file for a new labeler code request | Leave the NDC labeler code field blank on the initial request submission |
| 5 | Choose a submission route | Decide whether to submit via FDA Direct, SPL Xforms, or a commercial third-party tool through ESG | All SPL submissions not made through FDA Direct or Xforms must go through the Electronic Submissions Gateway (ESG NextGen) |
| 6 | Submit the SPL document | Transmit the completed SPL file through the chosen route | After FDA reviews the submission and assigns the labeler code, you must submit an updated labeler code form SPL with the newly assigned number filled in |
| 7 | Complete the confirmation submission | A second SPL submission with the assigned labeler code entered in the previously blank field | No drugs can be listed under the assigned labeler code without completing this confirmation step |
Company Identification Inputs: DUNS, Legal Name, and Address
The SPL request for an FDA labeler code must include the company name, DUNS number, and contact information for someone responsible for receiving FDA communications. The DUNS number is issued by Dun & Bradstreet and serves as a unique business identifier. For internal consistency, companies may compare their legal name and address details with the DUNS record before filing. This is editorial advice, not an FDA-mandated exact-match requirement.
SPL Document Preparation
The labeler code request is submitted as a Structured Product Labeling (SPL) document, which is an XML file conforming to FDA validation rules. On the initial request, the NDC labeler code field must be left blank. The document must include the company name, DUNS number, and contact information for the individual responsible for receiving FDA communications about drug listings under that labeler code. After FDA assigns a code, a second SPL submission is required with the assigned number entered in the labeler code field to complete the process. FDA provides step-by-step instructions for requesting and confirming a labeler code using FDA Direct on its guidance pages.
Choosing a Submission Route
FDA accepts SPL submissions through three channels. FDA Direct is a web-based tool available at direct.fda.gov that allows users to create and submit SPL files online. SPL Xforms is another FDA-provided authoring tool. Companies using commercial third-party or in-house submission tools must transmit their SPL files through the Electronic Submissions Gateway Next Generation (ESG NextGen). Foreign companies that already use ESG for other FDA submissions may find it efficient to route labeler code requests through the same gateway, while those new to SPL may prefer the guided interface of FDA Direct.
Boundary Table: What a Labeler Code Does and Does Not Do
One of the most common sources of confusion for foreign companies is the boundary between a labeler code and other FDA drug obligations. The table below clarifies what a labeler code is and what it is not.
| A Labeler Code IS | A Labeler Code IS NOT |
|---|---|
| An identifier for the firm (labeler) that manufactures or distributes a drug product | A separate code required for each individual manufacturing establishment; one labeler code covers all establishments under the same labeler |
| Required before listing a drug or reserving an NDC with FDA for the first time | A substitute for establishment registration, which is a separate submission type |
| Requested electronically via an SPL document through FDA Direct or ESG | Proof of product approval such as an approved NDA or ANDA |
| Assigned to the company marketing the drug | Proof of establishment compliance or current registration status |
| Subject to possible deactivation if there are no associated drug listings within two years | Authorization to commercially sell or distribute a drug product in the United States without the required approvals and listings |
A frequent misconception is that obtaining an FDA labeler code permits immediate commercial sale or distribution of a drug product in the United States. This is not the case. A labeler code is an identification and listing mechanism; it does not grant marketing authorization, waive the requirement for an approved NDA or ANDA, or eliminate the need for establishment registration and drug listing submissions. The three submission types described on FDA’s registration and listing instructions page are establishment registration, labeler code request, and drug listing, each serving a distinct purpose.
Conditional Two-Year Deactivation
A labeler code that has no associated drug listings may be deactivated after two years. Before relying on an older code with no associated listings, verify its current status and review FDA’s current instructions.
Updating Labeler Code Information
FDA’s page addresses updates to labeler code information when contact details change, ownership transfers through a merger or acquisition, or the company name changes. Labeler code information must be updated within 30 days of any change to contact information (e.g., name, physical address, email address), type of activities applicable to the entity (e.g., manufacturer or distributor), or type of drug(s) for which the labeler code will be used. This 30-day requirement is specific to labeler code information and is not a universal deadline for all drug registration and listing obligations. To update labeler code information, a company should create a copy or new version of the most recent SPL submission without changing the set ID, generate a new document ID or root ID, enter an appropriate effective date and version number (generally one number higher than the previous submission), modify the contact information as needed, and submit the updated SPL.
If a labeler code transfers to another company through a merger or acquisition, or if there is a name change, all product listings under that labeler code must be updated with the new labeler name. Companies should review FDA’s instructions directly for the specific update expectations that apply to their situation and consult regulatory counsel when ownership or structural changes are involved. For foreign companies preparing broader FDA engagement, the GDUFA III controlled correspondence decision map and the FDA MIE generic drug meeting checklist provide additional context on navigating FDA interactions.
Sources
This article is educational information, not legal/regulatory advice and not medical advice. Always consult FDA’s official guidance and qualified regulatory counsel for your specific circumstances.