What Is NDC Number?

What is NDC Number (National Drug Code) ?

NDC  number is 10 digit numerical code assigned to drugs. First 5 digits of the NDC  number  come from the labeler code.  Labeler code is assigned by the FDA  to manufacturer , distributor or brand owner of the product.   The first step  for NDC number is to obtain the labeler code from FDA. Our company can assist you get the labeler code. In order get the labeler code  you should  provide the  DUNS number,  company name and address . You can get DUNS number free of charge,  we can assist your company to get the DUNS number.

After you complete the below online form for labeler code , we shall prepare the labeler code application on behalf of your company and apply for the labeler code.  It may take 10 working days to obtain the labeler code.

Online labeler code form  

After receipt of the labeler code , we can help you to assign product code and pack code for  all your products.  NDC number can be assigned in  5 -4-1 or 5 -3-2 format, which means you can assign either 4 or 3 digit code product and 1 or 2 digit pack code.

Example

Let say, your company has obtained 12345 as 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.

Fore more information on NDC number format  , please visit the below link.

NDC Number

Drug Listing

After assigning the NDC number, we shall assist you to submit the drug listing to FDA. Drug listing is mandatory requirement for  drugs commercially distributed in the USA.  Drug listing can be verified at the below link.

National Drug Code Directory

 

 

 

 

 

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