How to Get an FDA Labeler Code for Drug Products

What Is an FDA Labeler Code?

A labeler code is a unique numerical identifier assigned by FDA to each entity that manufactures, repacks, relabels, or distributes drug products under its own name. The labeler code forms the first segment of the National Drug Code (NDC), which is the standard product identifier for drugs in the United States.

The NDC is a three-segment number structured as follows:

• Segment 1: Labeler Code (4 or 5 digits) — assigned by FDA; identifies the firm responsible for the drug product
• Segment 2: Product Code (3 or 4 digits) — assigned by the labeler; identifies the specific drug product (ingredient, strength, dosage form)
• Segment 3: Package Code (1 or 2 digits) — assigned by the labeler; identifies the package size and configuration

The total NDC is always 10 digits, but the segment lengths can vary (e.g., 4-4-2, 5-3-2, or 5-4-1 configurations). The format you use depends on the labeler code length that FDA assigns.

Important: The labeler code is assigned to the business entity, not to a specific product or facility. If your company has multiple manufacturing sites, you typically use the same labeler code for products distributed under your name, but you must register each facility separately.

Who Needs a Labeler Code?

You need an FDA labeler code if you intend to:

• Manufacture drug products for distribution in the United States (including for import)
• Repack or relabel drug products under your own name or under a private label
• Distribute drug products under your own label (even if manufactured by a contract manufacturer)
• Export drug products from a foreign country to the United States

The labeler code requirement applies to both prescription drugs and over-the-counter (OTC) drugs, including those marketed under a monograph as well as those with approved NDAs or ANDAs.

Entities that only distribute products under the manufacturer's label (without relabeling) generally do not need their own labeler code. However, if you put your company name on the label as the "distributed by" or "manufactured for" entity, you should obtain your own labeler code to list the products properly.

Prerequisites: DUNS Number and SPL Familiarity

Before you can apply for a labeler code, you must have the following in place:

DUNS Number

A Data Universal Numbering System (DUNS) number is a unique 9-digit identifier assigned by Dun & Bradstreet (D&B) to individual business entities. FDA uses DUNS numbers to identify establishments in the registration system. You need a DUNS number for each physical location that will be registered with FDA.

You can obtain a DUNS number free of charge from D&B. The process typically takes 1–3 business days for expedited requests or up to 30 days for standard requests. See our DUNS vs FEI guide for more details.

SPL Submission Capability

Labeler code requests are submitted as part of your initial establishment registration, which must be in SPL (Structured Product Labeling) format. You can use FDA's SPL Xforms tool, WebSPL, or commercial regulatory software to create your SPL submission.

FDA Account (FURLS/DRLS)

You need an active FDA Unified Registration and Listing System (FURLS) account to access the Drug Registration and Listing System (DRLS). Account creation is free and requires identity verification.

Step-by-Step: How to Get a Labeler Code

The labeler code is not obtained through a standalone application form. Instead, it is assigned as part of your initial drug establishment registration process. Here are the steps:

1. Obtain a DUNS number for your business entity from Dun & Bradstreet. Allow 1–30 days depending on request type.
2. Create an FDA FURLS/DRLS account at access.fda.gov. Complete identity verification and organization affiliation.
3. Prepare your registration SPL using FDA's SPL Xforms tool or equivalent software. Include your DUNS number, facility address, business operations (manufacturing, repacking, etc.), and contact information.
4. Designate a U.S. Agent (foreign establishments only). Include U.S. Agent name, address, phone, and email in the SPL. Your U.S. Agent must confirm acceptance.
5. Submit the registration SPL through DRLS. FDA's system will validate the XML and assign a labeler code upon acceptance.
6. Receive your labeler code — FDA typically assigns the code within a few business days of successful submission. The code will appear in your DRLS account.
7. Construct NDC numbers using your new labeler code as Segment 1, then assign Product Codes (Segment 2) and Package Codes (Segment 3) for each product.
8. Submit product listing SPL(s) for each drug product, including the NDC numbers you've constructed.

How the Labeler Code Links to Drug Listing

Once you have a labeler code, it becomes the foundation of your product identification in the U.S. drug supply chain. Every drug product you list with FDA is identified by an NDC number that starts with your labeler code.

The listing process under 21 CFR §207.49 requires you to submit, for each product:

• The complete NDC number (labeler code + product code + package code)
• The established (generic) name and proprietary (brand) name of the drug
• Active ingredient(s) and strength
• Dosage form and route of administration
• A copy of all labeling (prescribing information, patient labeling, Drug Facts, etc.)
• The name and DUNS number of each establishment where the drug is manufactured, packed, or tested

FDA publishes your NDC numbers and basic product information in the NDC Directory. Your labeling is published on DailyMed. These public records are used by pharmacies, wholesalers, hospitals, insurers, and customs authorities to verify the legitimacy of drug products entering the U.S. market.

Maintaining accurate NDC and listing information is critical. If your NDC numbers are incorrect or your listing is out of date, your products may face rejection at customs, refusal by wholesalers, or exclusion from insurance formularies.

Common Issues and How to Resolve Them

Several common issues arise during the labeler code and listing process:

• DUNS number mismatch — the DUNS number in your SPL must exactly match the number assigned by D&B. Any discrepancy (including address differences) will cause validation failures. Verify your DUNS record before submitting.
• SPL validation errors — common errors include missing required XML elements, malformed NDC numbers, and schema violations. Use FDA's validation tools before submitting to catch errors early.
• Duplicate labeler codes — if your company has already been assigned a labeler code (perhaps by a previous regulatory contact), do not request a new one. Contact FDA's DRLS help desk to recover your existing code.
• Labeler code vs. FEI number confusion — the labeler code identifies the business entity; the FEI (Facility Establishment Identifier) number identifies the physical facility. They are different numbers assigned through different mechanisms.
• U.S. Agent not designated — foreign establishments cannot complete registration without a U.S. Agent. This must be in place before submitting your registration SPL.

If you encounter issues during the process, Assurentry's drug registration team can provide guidance on resolving SPL validation errors, DUNS number issues, and other common obstacles.