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Home  /  Our Blog   /  What Is The National Drug Code & Why Do I Need To Include It?

What Is The National Drug Code & Why Do I Need To Include It?

The USA has strict laws regarding dealing with medicines on a commercial level for what they introduced the concept of national drug code. Section 510 of the U.S. Federal Food, Drugs, and Cosmetics requires submitting every new and updated medical information. This section was enacted in 1972, which requires all medicine manufacturers and stockholders to inform the Food and Drug Association about the drugs they intend to manufacture, distribute, and process.

What is NDC?​

NDC is the unique numerical code segmented into three parts to identify medicines used in the USA. NDC stands for National Drug Code. It is the responsibility of the FDA to publish the NDC medication codes as part of their NDC directory. This repository of NDC numbers is maintained regularly to follow the drug listing act of 1972. 

To read the detailed definition of NDC, visit the FDA website

According to the latest amendment in June 2011, only drugs that have been electronically listed can be added to the NDC directory. Any human or animal medicine not in the final form and ready to be marketed is not counted in the NDC directory.

National Drug Code Format​

The FDA provides each drug with a unique 10-digit code divided into three parts to give uniform and universal identification. These 3-part NDC number formats indicate the manufacturer/label, product, and package size.

Let’s discuss all three parts briefly:

1st Part: The first part of the code indicates the firm name that manufactures, relabels, repackages, or distributes the product.

2nd Part: This part indicates the strength or dosage of the medicine. This means that the exact formulation’s separate formulations or different dosages should be assigned other codes.

3rd Part: The last part indicates the package types and sizes. The package code indicates the quantitative and qualitative attributes of the medicine.

One thing to notice is that all three parts can have different numbers of digits. The label part may have 5 or 4 digits, the product part may have 4 or 3 digits, and the package part may have 1 or 2 numbers.

To summarize, we can have the following NDC product codes:

  • 4-4-2
  • 5-3-2 
  • 5-4-1

NDC Numbers With 11 Digits​

Some government entities including HIPAA and CMS (Centers for Medicare and Medicaid) require 11 digit medication codes. It depends on the payer if they need 10 digit or 11 digit NDC numbers.

If the NDC code is less than 11 digits, then a leading zero is added. The centers of Medicare and Medicaid use 11 digit configuration without hyphens, or any other characters.

According to an estimated prediction by the FDA, 5-digit medication codes will exhaust by max 2033. In 2018, FDA invited healthcare industry stakeholders and asked them for possible solutions for NDC product code. It was decided that the FDA will start assigning new 6-digit codes to all the medicines in near future. This transition will expand NDC code to 11 digits and two configurations will be used from then onwards; 6-3-2 and 6-4-1, making it 5 configurations in total.

Why Do We Need NDC Codes?​

It is essential to know the NDC codes and enter them in the claims because the players need this information to release reimbursements for the rendered medical services. If you need to remember to enter the NDC product code or enter the wrong or outdated NDC code, it will cause a claim denial.

Reasons Why a Medicine is Not in NDC Directory​?

If a product is not OTC, insulin or prescription medicine, it may not appear in the NDC directory.

  • The drug manufacturing firm has notified FDA that the medicine is not available commercially.
  • If the drug establishment has not submitted its registration information and drug’s information electronically, it will not appear in the NDC directory.

It is a good practice to always consult your healthcare provider to ensure that this information applies to your specific situation.

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