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FDA National Drug Code NDC Labeler Code
What is NDC Labeler Code ?
An NDC Labeler Code is a five-digit code assigned by the FDA to drug manufacturers, repackers, relabelers, and private-label distributors that market drug products under their own name. Companies that manufacture, package, label, or distribute drug products in the United States must complete FDA drug establishment registration and drug listing before marketing applicable products. As part of the FDA drug listing process, each product is assigned a National Drug Code (NDC), a unique identifier used throughout the U.S. pharmaceutical supply chain.
An NDC is currently a 10-digit code consisting of three segments. The first segment is the NDC labeler code, which identifies the company responsible for the product in the U.S. market. The remaining segments identify the specific drug product, including its formulation, strength, dosage form, and package size.
What are the NDC three segments?
The National Drug Code (NDC) is a unique 10-digit identifier used to track drugs in the United States. It’s structured in three segments. The FDA assigns the first segment, the Labeler Code, while the drug company assigns the Product and Package Codes before submitting the drug to the FDA for listing.
Labeler Code – Assigned by the FDA to identify the manufacturer or distributor.
Product Code – Identifies the specific drug product.
Package Code – Identifies the size and type of the package.
The labeler code must be obtained before a drug can be listed, and the manufacturer or distributor assigns the product and package codes.
What are the NDC Labeler Code assignment?
FDA NDC labeler code assignment involves few steps, outlined below. Please note that before assigning an NDC labeler code, FDA may request a review of the proposed product label and active-ingredient information to confirm that the company’s submission is aligned with the appropriate drug-listing regulatory pathway, including the applicable OTC drug monograph where relevant.
- Preparing Company Information: Including your company name, DUNS number, contact info, and product category.
- Submit SPL via ESG: Submission via Structured Product Labeling (SPL) file through the FDA’s Electronic Submissions Gateway (ESG).
- Wait for FDA Review: Once approved, the FDA assigns your NDC labeler code. You can then list your drug with the full NDC.
How can we assist you?
Obtaining an FDA NDC labeler code can be challenging, particularly for first-time applicants. Therefore, FDA Listing Inc. verifies key submission information in advance, including the DUNS number, company details, active ingredients, and relevant product-label information. We assist by:
- Serving as the U.S. agent for eligible foreign establishments.
- Preparing the required SPL submission.
- Communicating with FDA on the client’s behalf.
You can contact us by phone or email if you require assistance with the NDC Labeler code.
Service Details & Fees
395 USD
3-4 Days
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Frequently Asked Questions (FAQ)
What is an FDA Labeler Code, and who needs to request one?
An NDC Labeler Code is a unique 4- or 5-digit number assigned by the FDA to identify the company marketing a drug. Any manufacturer, repackager, relabeler, or private label distributor (PLD) selling human drugs in the U.S. must obtain a labeler code before listing products.
What are the three parts of a National Drug Code (NDC)?
An NDC consists of three segments: the Labeler Code (identifies the company), the Product Code (identifies the formulation, strength, and dosage form), and the Package Code (identifies package size and type).
Does having an assigned NDC or Labeler Code mean a drug is "FDA Approved"?
No, assigning a labeler code or generating an NDC number does not signify FDA approval or safety verification. It simply acts as a universal product identifier in the FDA Electronic Drug Registration and Listing System (eDRLS).
Can a company use one Labeler Code for multiple manufacturing facilities?
Yes, labeler codes are assigned at the corporate level, not to specific physical sites. A business with multiple manufacturing or processing locations can use a single labeler code across all facilities under common ownership.
How do you submit an NDC Labeler Code request to the FDA?
Requests must be submitted electronically through the FDA Direct portal using Structured Product Labeling (SPL) XML format. The submission requires the company’s legal name, DUNS number, contact information, and business activities.
Can an FDA Labeler Code expire or be deactivated?
Yes, the FDA automatically inactivates any labeler code that has no active drug listings associated with it for 24 consecutive months. Companies must list at least one product within two years to maintain an active labeler code.
Service Details & Fees
Labeler Code Request
395 USD
Time Required
3-4 Days
U.S. Agent
FDA Communications
20-Mins Consultation
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