How FDAbasics assist you with drug listing?
After you complete the onlineNDC drug listing form, we shall prepare the labeler code application on behalf of your company and submit it to the FDA. About ten business days are required to obtain alabeler codefrom the FDA.
After receipt of the labeler code, we shall help you assign an NDC code for your products.
NDC number format
NDC number can be assigned in 5 -4-1 or 5 -3-2 format, which means you can assign either a 4 or 3 digit code product and 1 or 2 digit pack code.
Let say your company has obtained 12345 as a labeler code.
NDC number for your product X can be assigned as below;
12345- labeler code | 678 – Product code |89 -Pack code
or
12345- labeler code | 6789 – Product code |1 -Pack code
You can choose any 3 or 4 digit number as product code and 1 or 2 digit code pack. However, product code should be unique for every product. Similarly, for the same product package code should be unique for each packing type or configuration.
For more information on the NDC number format, please visit the below link.
Drug Listing
After assigning an NDC number for your products, we shall assist you in submitting the drug listing to FDA.
It will take about 15 business days to complete the NDC drug listing process. If you have any questions about FDA registration and listing requirements, pleasecontact us.
