NDC Code | 0597-0390-13 |
Package Description | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (0597-0390-13) |
Product NDC | 0597-0390 |
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 | 25; 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] |