US Drug Registration and Listing

There are many reasons to choose us for filing your US Drug Listings:

• Help in registering your establishment
• Assistance in listing each drug with the FDA
• Solutions for registration renewal within the timeframe set by FDA
• Listing updates at any time in the calendar year
• Independently audit your products and collect and submit information
• Enable you to stay in compliance with FDA requirements.

According to the FDA, accurate, complete, and updated information related to establishment registration and drug listing is required to promote patient safety. For each drug identified, the establishment must provide the following information:

• NDC number of the final product if issued
• Strength of active ingredient per unit
• The source of the active ingredient
• The NDC number of the source drug if available
• The dosage form and route of administration
• The package description and the number of individual units produced
• The NDC number of bulk active ingredients if available

Any person engaged in drug manufacturing, preparing, propagating, compounding or processing in US or that are offered for import into US must register their establishments with the Food and Drug Administration (FDA) as well as list each drug manufactured at their establishment for commercial distribution. They must also submit updated information about their drug listing to FDA twice each year – June and December. The purpose is to notify FDA if there is any change in information.

All drugs registered with FDA must be listed in its database and maintained through period renewal. Only after the labeler’s code is issued, the drug listing will be added to the FDA’s database in around two business days.  FDA NDC database will confirm the drug listing and its status will be indicated. Drug listings must be updated annually to ensure their status is active.

Yes, there is no cost for listing drugs with the FDA.