The first step to get the NDC number is obtaining a labeler from the FDA and then the NDC number can be assigned to products using the labeler code obtained by the FDA. In this article, we have answered your questions about how to get NDC numbers in detail.
The below diagram will help you to understand how to get the NDC number
It will take about ten business days to obtain a labeler code, and after the labeler code is assigned, it will take 2 to 3 business days, to complete the drug listing process.
FDA does not charge a fee for an NDC drug listing.
Here is our fee structure for NDC drug listing assistance.
Labeler code application $ 399 one time fee
Drug establishment registration $ 299
Drug listing $ 299 ( fee may vary based on the product type)
Foreign facilities are required to appoint US Agent for labeler code application and drug establishment registration purpose/
FDAbasics can answer all your questions on How to Get an NDC number and assist you in complying with FDA drug listing requirements quickly. We offer complete assistance for NDC drug listing, labeler code application, and drug establishment registration. There is no hidden fee.
If you have any questions or need assistance with the NDC drug listing or NDC labeler code application, contact us.
You can find more information about the NDC number format at the below link.
If your product is detained at the port of entry due to noncompliance with FDA registration and listing requirements, FDAbasics shall offer quick assistance to comply with FDA requirements.
If you are worried about how to get the NDC number contact us and we will help you understand the NDC drug listing process and answer all your questions related to NDC number.