What is an NDC labeler code? FDAbasics

What is an NDC labeler code, and how to get it? 

 

NDC labeler code

NDC  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.

After obtaining an NDC labeler code from the FDA, the firm can submit the drug listing utilizing the labeler code assigned by the FDA. 

 

 

What is the difference between the NDC  code and labeler code?

NDC number Labeler code 
NDC is assigned to a product Labeler code is assigned to the company
NDC is a ten-digit number Labeler code is a five-digit number assigned by the FDA
The first five digits of the NDC number is labeler code

How to obtain a labeler code?

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.

What information is required for the labeler code application?

 

Company name, DUNS number, address, name of the contact person, email, and telephone number. US Agent information is required for foreign companies.

How can FDAbasics help you to obtain an NDC labeler code?

 

We shall prepare the labeler code request document in the SPL format and submit to the FDA on behalf of your company. We also offer US Agent services for foreign companies.   

What is your fee for the labeler code application?

Our fee for the labeler code application is $ 399. There is no FDA fee for obtaining a labeler code.  

If you have any questions about the NDC labeler code application, please contact us.

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