NDC Code | 63323-562-15 |
Package Description | 10 VIAL, SINGLE-USE in 1 CARTON (63323-562-15) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE (63323-562-41) |
Product NDC | 63323-562 |
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 | 20171030 |
Marketing Category Name | ANDA |
Application Number | ANDA090189 |
Manufacturer | Fresenius Kabi USA, LLC |
Substance Name | BIVALIRUDIN |
Strength | 250 |
Strength Unit | mg/1 |
Pharmacy Classes | Anti-coagulant [EPC], Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA] |