| Product NDC: | 52125-392 |
| Proprietary Name: | Glyburide and Metformin |
| Non Proprietary Name: | Glyburide and Metformin |
| Active Ingredient(s): | 2.5; 500 mg/1; mg/1 & nbsp; Glyburide and Metformin |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, FILM COATED |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 52125-392 |
| Labeler Name: | REMEDYREPACK INC. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA076345 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20130514 |
| Package NDC: | 52125-392-23 |
| Package Description: | 180 TABLET, FILM COATED in 1 VIAL (52125-392-23) |
| NDC Code | 52125-392-23 |
| Proprietary Name | Glyburide and Metformin |
| Package Description | 180 TABLET, FILM COATED in 1 VIAL (52125-392-23) |
| Product NDC | 52125-392 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Glyburide and Metformin |
| Dosage Form Name | TABLET, FILM COATED |
| Route Name | ORAL |
| Start Marketing Date | 20130514 |
| Marketing Category Name | ANDA |
| Labeler Name | REMEDYREPACK INC. |
| Substance Name | GLYBURIDE; METFORMIN HYDROCHLORIDE |
| Strength Number | 2.5; 500 |
| Strength Unit | mg/1; mg/1 |
| Pharmaceutical Classes | Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] |