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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 purposes. NDC is a  10 digit code . Each drug product should have a unique NDC code.

NDC Code Format

NDC code

 

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

In short,  FDA assigns the first five digits of the NDC Code, and the remaining five digits are assigned by the labaler (brand owner)/manufacturer. Following are 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 labeler, you have to appoint US Agent for FDA communication. We can act as your US Agent and facilitate communication with the FDA. 

How to convert a 10 digit NDC  11 digit?

You may have to provide for 11 digit NDC for billing purposes. You can convert the existing 10 digit NDC number to 11 numbers by adding an 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 the initial NDC drug listing, you have to submit the annual no change certification if there is no update made in the calendar year. 

Please note, drug listing one of the requirements for commercially marketed drug products in the United States. You have to also comply with other requirements, such as labeling and GMP.

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

 

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