NDC Code | 0597-0380-22 |
Package Description | 1 BOTTLE in 1 CARTON (0597-0380-22) / 7 TABLET, EXTENDED RELEASE in 1 BOTTLE |
Product NDC | 0597-0380 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Trijardy Xr |
Non-Proprietary Name | Empagliflozin, Linagliptin, Metformin Hydrochloride |
Dosage Form | TABLET, EXTENDED RELEASE |
Usage | ORAL |
Start Marketing Date | 20200423 |
Marketing Category Name | NDA |
Application Number | NDA212614 |
Manufacturer | Boehringer Ingelheim Pharmaceuticals, Inc. |
Substance Name | EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE |
Strength | 10; 5; 1000 |
Strength Unit | mg/1; mg/1; mg/1 |
Pharmacy Classes | Biguanide [EPC], Biguanides [CS], Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA] |