Product manufactured by Cardinal Health

Application Nr Approved Date Route Status External Links
NDA019594 1987-12-31 Oral DISCN Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage 1.ursodiol Is Indicated For Patients With Radiolucent, Noncalcified Gallbladder Stones < 20 Mm In Greatest Diameter In Whom Elective Cholecystectomy Would Be Undertaken Except For The Presence Of Increased Surgical Risk Due To Systemic Disease, Advanced Age, Idiosyncratic Reaction To General Anesthesia, Or For Those Patients Who Refuse Surgery. Safety Of Use Of Ursodiol Beyond 24 Months Is Not Established. 2.ursodiol Is Indicated For The Prevention Of Gallstone Formation In Obese Patients Experiencing Rapid Weight Loss.

All Formulated Excipients (0 Total)


Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Ursodiol URSODIOL ZINC3914809