NDC Code | 16729-275-67 |
Package Description | 10 VIAL, SINGLE-USE in 1 CARTON (16729-275-67) / 5 mL in 1 VIAL, SINGLE-USE (16729-275-03) |
Product NDC | 16729-275 |
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 | 20181107 |
Marketing Category Name | ANDA |
Application Number | ANDA206551 |
Manufacturer | Accord Healthcare, Inc. |
Substance Name | BIVALIRUDIN |
Strength | 250 |
Strength Unit | mg/5mL |
Pharmacy Classes | Anti-coagulant [EPC], Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA] |