| NDC Code | 0310-6250-95 |
| Package Description | 1 BLISTER PACK in 1 CARTON (0310-6250-95) / 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK |
| Product NDC | 0310-6250 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Proprietary Name | Xigduo |
| Proprietary Name Suffix | Xr |
| Non-Proprietary Name | Dapagliflozin And Metformin Hydrochloride |
| Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
| Usage | ORAL |
| Start Marketing Date | 20141029 |
| Marketing Category Name | NDA |
| Application Number | NDA205649 |
| Manufacturer | AstraZeneca Pharmaceuticals LP |
| Substance Name | DAPAGLIFLOZIN PROPANEDIOL; 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] |