Drug Listing Services

Owners or operators of drug manufacturing establishments are required to register their establishments with FDA. Registrants are also required to list each drug manufactured at their establishment(s) intended for commercial distribution and submit updated drug listing information to FDA twice each year, in June and December, notifying FDA if this information has changed.

Establishment registration and drug listing data are submitted electronically using structured product labeling (SPL) format. This provides the agency with a list of all drug manufacturers currently producing drugs for sale in the U.S. and a current inventory of all drugs in the U.S. supply chain. Parts of the data are published in the FDA National Drug Code Directory, FDA label repository, FDA drug establishment current registration site and NIH’s DailyMed.

Complete, accurate and up-to-date establishment registration and drug listing information is essential to promote patient safety. FDA relies on establishment registration and drug listing information for several key programs, including:

Catain can provide Drug Listing services at just $600. There are no additional FDA charges for registration.

Click here ==> Drug Listing Form

If you have questions, please get in touch.