| NDC Code | 0597-0395-82 |
|---|
| Package Description | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (0597-0395-82) |
|---|
| Product NDC | 0597-0395 |
|---|
| 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 | 5; 2.5; 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] |
|---|