NDC Code | 66993-362-30 |
Package Description | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (66993-362-30) |
Product NDC | 66993-362 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Dapagliflozin And Metformin Hydrochloride |
Non-Proprietary Name | Dapagliflozin And Metformin Hydrochloride |
Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
Usage | ORAL |
Start Marketing Date | 20240103 |
Marketing Category Name | NDA AUTHORIZED GENERIC |
Application Number | NDA205649 |
Manufacturer | PRASCO, LLC |
Substance Name | DAPAGLIFLOZIN PROPANEDIOL; METFORMIN HYDROCHLORIDE |
Strength | 10; 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] |