| NDC Code | 70748-101-06 |
| Package Description | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70748-101-06) |
| Product NDC | 70748-101 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Proprietary Name | Dapagliflozin And Metformin Hydrochloride |
| Non-Proprietary Name | Dapagliflozin And Metformin Hydrochloride |
| Dosage Form | TABLET, EXTENDED RELEASE |
| Usage | ORAL |
| Start Marketing Date | 20260406 |
| Marketing Category Name | ANDA |
| Application Number | ANDA211579 |
| Manufacturer | Lupin Pharmaceuticals, Inc. |
| Substance Name | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
| Strength | 5; 500 |
| Strength Unit | mg/1; mg/1 |
| Pharmacy Classes | Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA] |