Ursodiol - 0378-1730-01 - (ursodiol)

Alphabetical Index


Drug Information of Ursodiol

Product NDC: 0378-1730
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: 0378-1730
Labeler Name: Mylan Pharmaceuticals Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA090530
Marketing Category: ANDA
Start Marketing Date: 20120507

Package Information of Ursodiol

Package NDC: 0378-1730-01
Package Description: 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1730-01)

NDC Information of Ursodiol

NDC Code 0378-1730-01
Proprietary Name Ursodiol
Package Description 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1730-01)
Product NDC 0378-1730
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name ursodiol
Dosage Form Name CAPSULE
Route Name ORAL
Start Marketing Date 20120507
Marketing Category Name ANDA
Labeler Name Mylan Pharmaceuticals 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