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NDC code requirement and application process explained

21

Aug

2019

How can I apply for NDC code ?

NDC stands for National Drug Code which is also used for billing and  insurance purpose. NDC is 10 digit code . Each drug product should have unique NDC code.

 

NDC code
NDC Code Format

 

First  five digits of NDC code are assigned by FDA, which is known as labeler code. Labeler code identifies the product “labeler” (brand owner or the company who take ownership of the product).  You can find examples of NDC number format on our website. 

In short,  FDA assigns first five digits of the NDC Code and remaining five digits are assigned by the labaler (brand owner). Here is the step by step instructions for NDC drug listing. 

  1. Obtain the labeler code
  2. Activate the labeler code 
  3. Register the manufacturer of product  (if not registered , previously )
  4. Submit the drug listing 

After successful submission of drug listing you can find your NDC drug listing  on the Dailymed and FDA NDC database. 

If you are foreign manufacturer or labaler , you have to  also appoint U.S Agent for FDA communication. We can act as your U.S Agent and facilitate the communication with FDA. 

How to convert 10 digit NDC  11 digit ?

You may have to provide for 11 digit NDC for billing purpose. You can convert existing 10 digit NDC number to 11 number by adding additional “0” in  in the labeler code, Product code or Pack Code. 

10 Digit NDC

11 digit NDC by

Adding  “0” to Labeler code

11 digit NDC by

Adding  “0” to Product  Code

11 digit NDC by

Adding  “0” to  Pack Code

12345-678-10

012345-178-10

12345-0178-10

12345-0178-010

After initial NDC drug listing, you have to also submit the annual no change certification if there is no update made in the calendar year. 

Please note, drug listing one of the requirement for  commercial marketed drug products in the United States, you have to also comply with other requirements such as labelling  and GMP .

If you have any  questions, do not hesitate contact us. 

 

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