Ursodiol - 42291-850-18 - (Ursodiol)

Alphabetical Index


Drug Information of Ursodiol

Product NDC: 42291-850
Proprietary Name: Ursodiol
Non Proprietary Name: Ursodiol
Active Ingredient(s): 300    mg/1 & nbsp;   Ursodiol
Administration Route(s): ORAL
Dosage Form(s): CAPSULE
Coding System: National Drug Codes(NDC)

Labeler Information of Ursodiol

Product NDC: 42291-850
Labeler Name: AvKARE, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA075517
Marketing Category: ANDA
Start Marketing Date: 20100716

Package Information of Ursodiol

Package NDC: 42291-850-18
Package Description: 180 CAPSULE in 1 BOTTLE (42291-850-18)

NDC Information of Ursodiol

NDC Code 42291-850-18
Proprietary Name Ursodiol
Package Description 180 CAPSULE in 1 BOTTLE (42291-850-18)
Product NDC 42291-850
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name Ursodiol
Dosage Form Name CAPSULE
Route Name ORAL
Start Marketing Date 20100716
Marketing Category Name ANDA
Labeler Name AvKARE, Inc.
Substance Name URSODIOL
Strength Number 300
Strength Unit mg/1
Pharmaceutical Classes Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient]

Complete Information of Ursodiol


General Information