| Product NDC: | 0093-5360 | 
| Proprietary Name: | Ursodiol | 
| Non Proprietary Name: | Ursodiol | 
| Active Ingredient(s): | 250 mg/1 & nbsp; Ursodiol | 
| Administration Route(s): | ORAL | 
| Dosage Form(s): | TABLET, FILM COATED | 
| Coding System: | National Drug Codes(NDC) | 
| Product NDC: | 0093-5360 | 
| Labeler Name: | Teva Pharmaceuticals USA Inc | 
| Product Type: | HUMAN PRESCRIPTION DRUG | 
| FDA Application Number: | ANDA079184 | 
| Marketing Category: | ANDA | 
| Start Marketing Date: | 20090518 | 
| Package NDC: | 0093-5360-01 | 
| Package Description: | 100 TABLET, FILM COATED in 1 BOTTLE (0093-5360-01) | 
| NDC Code | 0093-5360-01 | 
| Proprietary Name | Ursodiol | 
| Package Description | 100 TABLET, FILM COATED in 1 BOTTLE (0093-5360-01) | 
| Product NDC | 0093-5360 | 
| 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 | 250 | 
| Strength Unit | mg/1 | 
| Pharmaceutical Classes | Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] |