| Product NDC: | 64980-139 | 
| 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: | 64980-139 | 
| Labeler Name: | Rising Pharmaceuticals, Inc. | 
| Product Type: | HUMAN PRESCRIPTION DRUG | 
| FDA Application Number: | ANDA077895 | 
| Marketing Category: | ANDA | 
| Start Marketing Date: | 20061005 | 
| Package NDC: | 64980-139-05 | 
| Package Description: | 500 CAPSULE in 1 BOTTLE, PLASTIC (64980-139-05) | 
| NDC Code | 64980-139-05 | 
| Proprietary Name | URSODIOL | 
| Package Description | 500 CAPSULE in 1 BOTTLE, PLASTIC (64980-139-05) | 
| Product NDC | 64980-139 | 
| Product Type Name | HUMAN PRESCRIPTION DRUG | 
| Non Proprietary Name | URSODIOL | 
| Dosage Form Name | CAPSULE | 
| Route Name | ORAL | 
| Start Marketing Date | 20061005 | 
| Marketing Category Name | ANDA | 
| Labeler Name | Rising Pharmaceuticals, Inc. | 
| Substance Name | URSODIOL | 
| Strength Number | 300 | 
| Strength Unit | mg/1 | 
| Pharmaceutical Classes | Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] |