| Product NDC: | 66993-406 |
| 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) |
| Product NDC: | 66993-406 |
| Labeler Name: | PRASCO Laboratories |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA020675 |
| Marketing Category: | NDA AUTHORIZED GENERIC |
| Start Marketing Date: | 20090701 |
| Package NDC: | 66993-406-02 |
| Package Description: | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (66993-406-02) |
| NDC Code | 66993-406-02 |
| Proprietary Name | Ursodiol |
| Package Description | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (66993-406-02) |
| Product NDC | 66993-406 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | ursodiol |
| Dosage Form Name | TABLET, FILM COATED |
| Route Name | ORAL |
| Start Marketing Date | 20090701 |
| Marketing Category Name | NDA AUTHORIZED GENERIC |
| Labeler Name | PRASCO Laboratories |
| Substance Name | URSODIOL |
| Strength Number | 500 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] |