Host: Captain Mary Kremzner
Pharmacist: Henry Yu, Pharm D.
CAPT Kremzner: The “NDC Directory” locates unique National Drug Codes for marketed products. It’s a quick, easy, online resource.
Hi, I’m Captain Mary Kremzner and this is Drug Info Rounds, brought to you by the pharmacists in the FDA’s Division of Drug Information. My colleague Dr. Henry Yu joins me today to share some background about the NDC Directory.
DR Yu: Currently, drug products are identified and reported using a unique, 10-digit, three-segment number. This is called the National Drug Code, most often referred to as the NDC number. The FDA assigns the first segment, called the labeler code. A “labeler” is a firm that manufactures or distributes the drug, including drug re-packagers or re-labelers. This segment may contain 4 or 5 digits. The second segment, the product code, identifies the drug including the specific strength, dosage form, and formulation. This segment may contain 3 or 4 digits. The third segment, the package code, identifies package sizes and types. This segment may include 1 or 2 digits. The firm assigns both the product and package codes. Currently, NDCs are created in one of the following configurations: 4-4-2, 5-3-2, or 5-4-1.
All drugs entering US commercial distribution are required to be listed with the FDA. Firms submit the NDCs assigned to the drugs they manufacture or distribute as part of their listing requirements. The FDA publishes a list of these NDC numbers and other information submitted, as part of the listing information in the online NDC Directory. It’s important to note that the assignment of an NDC number does not in any way denote FDA approval of the product.
CAPT Kremzner: Many pharmacists ask what types of products are included or excluded in the NDC directory. They also ask why two directories are listed. Will you speak to this?
DR Yu: Drug listing information has historically been submitted to the FDA through paper forms. Changes in the Federal Food, Drug and Cosmetic Act required firms to submit this information electronically. Until June 1, 2011, FDA published those NDCs in what is now known as the “Old NDC Directory”. A final update of the old directory was published in July 2012.
After the launch of the electronic drug registration and listing system in June 2009, the amount of electronic listing information increased significantly. FDA took that opportunity to publish the information in a new and improved version of the directory, called the “New NDC Directory.” While the old directory only included human prescription drugs and insulin products, the new version includes all electronically listed drugs in their final marketed format including over-the-counter drugs. The new directory also provides data elements, such as the Drug Enforcement Administration schedule and pharmacological class, which were not included in the old version. The “New NDC Directory” is updated every day. Both directories are still searchable on the FDA website or can be downloaded and searched as data files.
FDA tries to ensure that the new NDC directory includes information on all listed drugs in US commercial distribution in their final marketed form, as submitted to the FDA by the labeler. It includes both unapproved and approved drugs, some over the counter products, and vaccines. The directory does not include animal drugs, blood products, or human drugs that are not in final marketed form, such as Active Pharmaceutical Ingredients, drugs for further processing, drugs manufactured exclusively for a private label distributor or drugs that are marketed solely as part of a kit or combination product not marketed or dispensed individually.
CAPT Kremzner: Will you speak to the accuracy of the information found in the NDC directory and review where a discrepancy should be reported?
DR Yu: The information published in the NDC Directory is extracted from the listing information submitted to the FDA. Firms are responsible for submitting accurate and complete information to the Agency at the time of their product listing. FDA uses various tools including automated validations and surveillance methods to help ensure the quality of the information published in the Directory, but cannot detect every deficiency. If you find any inaccurate information on the Directory you can contact us. The labeler will be contacted and requested to correct the information.
CAPT Kremzner: How about a demonstration on how to search for a product in the New NDC directory?
DR Yu: The new NDC directory can be searched using the proprietary name, the application number, the labeler name, the active ingredient, or by the NDC number itself. For example, if we choose to search by the proprietary name and type in a drug product such as Eliquis also known as apixaban, a blood thinning medication, the directory will populate seven Eliquis products with NDC numbers. In addition to the NDC numbers, the chart also provides the product type name, non-proprietary name, dosage form, route of administration, beginning marketing date, end marketing date, application number, labeler name, strength, package code and package description.
CAPT Kremzner: You’ve demonstrated how the new NDC directory is a useful resource with searchable features and many added components for healthcare practitioners. If you have questions about the NDC directory, call or email FDA’s Division of Drug Information.