| Product NDC: | 0904-6221 |
| 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) |
| Product NDC: | 0904-6221 |
| Labeler Name: | Major Pharmaceuticals |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA075517 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20110401 |
| Package NDC: | 0904-6221-60 |
| Package Description: | 100 CAPSULE in 1 BOTTLE (0904-6221-60) |
| NDC Code | 0904-6221-60 |
| Proprietary Name | Ursodiol |
| Package Description | 100 CAPSULE in 1 BOTTLE (0904-6221-60) |
| Product NDC | 0904-6221 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Ursodiol |
| Dosage Form Name | CAPSULE |
| Route Name | ORAL |
| Start Marketing Date | 20110401 |
| Marketing Category Name | ANDA |
| Labeler Name | Major Pharmaceuticals |
| Substance Name | URSODIOL |
| Strength Number | 300 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] |