It will take about ten business days to obtain a labeler code. After labeler code approval within 2 to 3 business days, the drug listing process can be completed.
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 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 for the NDC drug listing or NDC labeler code application, contact us.
You can find more information about 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.