NDC Numbers

What are NDC Numbers?

NDC stands for National Drug Code.

It’s a unique code used to distribute drugs throughout the United States that are used by people.

In 1972, the Drug Listing Act as established so that the FDA (Food and Drug Administration) can keep track of all drugs processed, sold, manufactured and prepared, by having drug manufacturing establishments send them their list.

The listed drugs are then reported and identified using the NDC. To understand the NDC we must understand how they are formatted.

How are NDC Numbers Formatted?

An NDC Number is a one-of-a-kind 10 digit number with 3 segments assigned to the drugs under the US Federal Food, Drug and Cosmetic Act.

This Act (abbreviated as FFDCA) was passed in 1938 to give the FDA authority to oversee the safety of food, drugs and cosmetics. This act was formed because over 100 patients died from a sulfanilamide medication.

The first segment is the vendor (or labeler), the second segment is the product, and the third is the trade package. The following is a short explanation of what each one is:

  • Segment 1: The labeler code is 4 to 5 digits long and is assigned by the FDA. A labeler is who distributes and packages the drug.
  • Segment 2: Product codes are 3 to 4 digits in length and display the strength, dosage and formulation for the firm.
  • Segment 3: The package code is 1 to 2 digits long and displays package form and size.

The labeler code is assigned by the FDA, but the product and package codes are assigned by the labeler.

In the past the labeler could reassign a code that was no longer in use to new products, but since the FDA changed their regulations, this isn’t allowed anymore.

Each NDC has 10 digits and are always in one of the following formats: 5-4-1, 5-3-2 or 4-4-2.

They must always be separated by dashes since there is now a mandatory electronic listing since June 2009.

Important facts about NDC Numbers

At this moment, the National Drug Code Directory is updated semi-monthly by the FDA.

Don’t think that because a drug has an NDC it means that it’s approved.

The FDA requires that they have one, but it doesn’t mean the drug has been verified.

In the NDC directory, there is not a complete list of every drug on the market. Blood products, animal drugs, human drugs that aren’t in their final market form, or drugs sold as combination drugs aren’t on the list.

There are differences between the old NDC directory and the new NDC directory.

The previous version only included insulin and human prescription drugs and left out OTC’s (over the counter) drugs. The new NDC directory, on the other hand, has human prescribed drugs and OTC’s electronically listed that have been prepared, compounded or processed by the manufacturer for marketing and distribution.

The file formats have also been updated. There are two files, the Products file and Packages file. They are linked using the PRODUCTNDC format. There is also both a spreadsheet version and a delimited CSV format version.

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