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Ursodiol
Ursodiol - 0093-5361-01 - (Ursodiol)
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] |
