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FDA – Drugs

NDC Number

Fee: $199

The National Drug Code (NDC) is a 10-digit code that identifies each drug and its package: the labeler code assigned by FDA (4 to 6 digits), the product code and the package code. A new product code is required when the drug’s name, active ingredient, strength, dosage form or prescription/OTC status changes. FDA will move the NDC to a uniform 12-digit format starting March 7, 2033.

Who Is Obligated?

Companies that list their drugs with FDA (labelers).

What We Do

  • We apply for the labeler code.
  • We structure the product and package codes according to the rules.
  • We assess whether a product change requires a new code.

What You Receive

  • Labeler code
  • NDC list for products and packages
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NDC Labeler Code Application

Company details for obtaining an NDC labeler code from FDA so that your products can be assigned NDC numbers.

  1. 1 Preliminary Information
  2. 2 Facility
  3. 3 Products and Invoice
  4. 4 Submit
1. Preliminary Information
Does your company already have a labeler code? *
In what capacity do you appear on the label? *

Your details are used only to prepare your application. An unfinished application is kept in this tab.

Frequently Asked Questions

What does the NDC identify?
The NDC is a 10-digit code that identifies each drug and its package: it consists of the labeler code assigned by FDA, the product code and the package code.
If I change my product, does the code change?
A new product code is required when the drug’s name, active ingredient, strength, dosage form or prescription/OTC status changes.
Will the NDC format change?
Yes. FDA will move the NDC to a uniform 12-digit format starting March 7, 2033.

Sources: 21 CFR 207.33; 21 CFR 207.35; FDA: National Drug Code Format.