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, the labeler code. A “labeler” is a firm that manufactures or distributes the drug, including drug re-packagers or re-labelers. This segment contains 4 or 5 digits. The second segment, the product code, identifies the drug, including the specific strength, dosage form, and formulation. The third segment, the package code, identifies package sizes and types. The firm assigns the product and package codes. All drugs entering U.S. commercial distribution are required to be listed with the FDA. Firms submit the NDCs numbers assigned to the drugs they manufacture or distribute as part of their listing requirements. The FDA publishes these NDC numbers and other information submitted the online NDC Directory The assignment of an NDC number does not in any way denote FDA approval of the product.
Handy tool, requires correct format
A useful tool for looking up no -biologic drugs approved by FDA. It requires that you use the correct format for NDC codes, which may not be obvious to all. For billing purposes, the NDC codes are usually converted to 11-digit codes, but this app requires the original 10-digit code in its hyphenated format, i.e., 4-4-2, 5-3-2, or 5-4-1. Once you do this, results are quickly available. It would be useful to have the formatting requirements listed clearly alongside the search as I see others have had trouble using this app successfully. It would also be convenient if the results included links to the NDAs or the most recent label, but perhaps that’s for another update.
Did not successfully find a drug from the code
Did not work at all for me. It could not Look up drugs from the code.
NDC Numbers
I also searched by the NDC number and did not receive any information.
It works
Good app, use the - symbol for NDC*
Current version does not appear to work
I tried searching a few NDC numbers I know, some proprietary product names, and some nonproprietary names. Each search returned, "Your search returned no records." Disappointed.
This release Includes a bug fix for NDC number search.
Subscribe our newsletter and get useful information every week.