FDA Drug Establishment Registration and NDC Labeler code

Below are some common questions from Drug establishments with more than one manufacturing location or a subsidiary or affiliate company.

• 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 a separate Labeler code?

• Can we use the same labeler code of the 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 a separate SPL for establishment registration and labeler code request.

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

Labeler code is not site-specific but company-specific; if a company has a labeler code for its corporate office and has 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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