Labeler Code Registration

Labeler Code Registration

Fee: $349 USD
(One-Time Fee)

Labeler Code is a five-digit number assigned by the FDA to firms intended to market/manufacture the drug. Labeler code constitutes the first five digits of the NDC number.

Companies are required to apply for labeler code request to the FDA in the SPL format. After receipt of the application FDA shall review the company name and address in the DUNS database and assign the labeler code.

It will take about ten business to obtain a labeler code from the FDA.We will prepare the labeler code request document and submit to the FDA on behalf of your company.

To have “FDA Registration Assistance” obtain your Labeler Code please CONTACT US.

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