NDC Code | 0310-6260-60 |
Package Description | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0310-6260-60) |
Product NDC | 0310-6260 |
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; 1000 |
Strength Unit | mg/1; mg/1 |
Pharmacy Classes | Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA] |