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  4. Electronic Drug Registration and Listing System (eDRLS)
  5. Drug Registration and Listing Instructions
  6. How to Request a Labeler Code
  1. Drug Registration and Listing Instructions

How to Request a Labeler Code

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 with FDA for the first time. The labeler code identifies the company marketing the drug. A separate labeler code is not required for each establishment manufacturing the drug with that labeler code. A manufacturer with multiple establishments can use one labeler code for all establishments. Generally, only drug manufacturers and distributors need a labeler code. A company that does not manufacture or distribute drugs in the U.S. should not apply for a labeler code.

A labeler code that has no associated drug listings may be deactivated after two years.

Requesting labeler codes

  • Create a labeler code request structured product labeling (SPL) document to request a new labeler code
  • Leave the NDC labeler code field blank
  • Include all necessary data (e.g., name and DUNS number of the company, contact information of someone responsible for receiving FDA communications related to drug listings with NDCs under that labeler code):
  • Submit SPL
  • After FDA reviews the submission and assigns the labeler code, submit an updated labeler code form SPL as described below with the newly assigned number filled in to complete the process (no drugs can be listed under the assigned labeler code without completing this step)

Visit instructions to request a labeler code using FDA Direct (page three) and instructions to confirm a labeler code using FDA Direct (page 12) for more information.

Updating labeler codes

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. Additionally, if a labeler code transfers to another company through a merger or acquisition, or if there’s a name change, all product listings under that labeler code must be updated with the new labeler name.

To update labeler code information, include contact information and name changes of the company or changes in ownership:

  • Create a copy/new version of the most recent submission
  • Do not change the set ID
  • Generate a new document ID/root ID
  • Enter an appropriate effective date and version number (generally, one number higher than the previous submission)
  • Modify contact information as appropriate
  • Submit SPL

Visit instructions to update a labeler code using FDA Direct (page 12) for more information.

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