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National Drug Code (NDC)

What is the National Drug Code (NDC)?

The National Drug Code (NDC) is a unique 11-digit number used to identify and report drugs to the FDA.

The NDC 11-digit number is broken into three segments, with a 5-4-2 format. If the number is not 11 digits long, a leading zero should be added to the segment missing a digit. For example, a drug with an NDC of 1234-1234-12 would become 01234-1234-12 since the first segment was only 4 digits instead of 5.

The first five digits signify the labeler, the next four digits correlate to the product code, and the final two digits are the package code.

All listed NDC numbers are published by the FDA in the NDC Directory, which is updated daily. The NDC Directory contains data submitted for all finished drugs, including over-the-counter drugs, prescription drugs, unapproved drugs, approved drugs, and repackaged or relabeled drugs.

It’s important to note that inclusion in the NDC Directory does not correlate to FDA approval for a drug.

Why is the National Drug Code (NDC) important to healthcare?

The NDC number is important to healthcare because it provides complete transparency regarding the drug name, manufacturer, strength, dosage, and package size.

Additionally, the NDC is very important in the hospital billing system. Medicare claims, in particular, must include the exact NDC of drugs administered to patients, otherwise, CMS will not reimburse the hospital.