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FDA Drug Establishment Registration and NDC Labeler code

Below are some common questions from Drug establishments having more than one manufacturing location or having subsidiary or affiliate companies.

  • Does each manufacturing location need FDA registration and FEI Number?

  • Does one FDA registration number good for other manufacturing locations also?

  • Does each establishment location need its own DUNS number?

  • Does each manufacturing location need separate Labeler code?

  • Can we use the same labeler code of parent company?

  • FDA registration number and labeler code are same?

  • FDA Drug establishment registration and Labeler code are two different requirements, each manufacturer must submit separate SPL for establishment registration and labeler code request.

    FDA Establishment registration is site specific and each manufacturing location must register separately and must have its own DUNS number, FDA will assign unique FEI number for each location.

    Labeler code is not site specific but company specific, if a company have labeler code for its corporate office and have multiple locations or subsidiaries, the same labeler code can be used for all locations. The labeler code is assigned to the labeler usually the company that owns the brand.

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