If you are a drug manufacturer or private label distributor, you have likely had a question about FDA Establishment Registrations, National Drug Code (NDC) numbers and product listings. They can be confusing concepts! Who needs them, how do you get them, what do the various parts of the codes (labeler/product/package), mean and who is actually responsible for assigning the numbers?
EAS Senior Advisor for OTC Drugs and Labeling, Susan Crane, breaks down this seemingly confusing process into simple and easy to understand steps. She will explain the basics of the NDC numbers, how and why FDA uses them and helps you to understand what information is required for listing your products.