Ursodiol - 0093-5361-01 - (Ursodiol)

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Drug Information of Ursodiol

Product NDC: 0093-5361
Proprietary Name: Ursodiol
Non Proprietary Name: Ursodiol
Active Ingredient(s): 500    mg/1 & nbsp;   Ursodiol
Administration Route(s): ORAL
Dosage Form(s): TABLET, FILM COATED
Coding System: National Drug Codes(NDC)

Labeler Information of Ursodiol

Product NDC: 0093-5361
Labeler Name: Teva Pharmaceuticals USA Inc
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA079184
Marketing Category: ANDA
Start Marketing Date: 20090518

Package Information of Ursodiol

Package NDC: 0093-5361-01
Package Description: 100 TABLET, FILM COATED in 1 BOTTLE (0093-5361-01)

NDC Information of Ursodiol

NDC Code 0093-5361-01
Proprietary Name Ursodiol
Package Description 100 TABLET, FILM COATED in 1 BOTTLE (0093-5361-01)
Product NDC 0093-5361
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name Ursodiol
Dosage Form Name TABLET, FILM COATED
Route Name ORAL
Start Marketing Date 20090518
Marketing Category Name ANDA
Labeler Name Teva Pharmaceuticals USA Inc
Substance Name URSODIOL
Strength Number 500
Strength Unit mg/1
Pharmaceutical Classes Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient]

Complete Information of Ursodiol


General Information