NDC Code | 71288-427-11 |
Package Description | 10 VIAL, SINGLE-DOSE in 1 CARTON (71288-427-11) > 5 mL in 1 VIAL, SINGLE-DOSE (71288-427-10) |
Product NDC | 71288-427 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Bivalirudin |
Non-Proprietary Name | Bivalirudin |
Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
Usage | INTRAVENOUS |
Start Marketing Date | 20180716 |
Marketing Category Name | ANDA |
Application Number | ANDA091602 |
Manufacturer | Meitheal Pharmaceuticals Inc. |
Substance Name | BIVALIRUDIN |
Strength | 250 |
Strength Unit | mg/5mL |
Pharmacy Classes | Anti-coagulant [EPC], Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA] |