| 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] |