Product NDC: | 50419-150 |
Proprietary Name: | Refludan |
Non Proprietary Name: | lepirudin |
Active Ingredient(s): | 50 mg/mL & nbsp; lepirudin |
Administration Route(s): | INTRAVENOUS |
Dosage Form(s): | POWDER |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 50419-150 |
Labeler Name: | Bayer HealthCare Pharmaceuticals Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA020807 |
Marketing Category: | NDA |
Start Marketing Date: | 20070309 |
Package NDC: | 50419-150-57 |
Package Description: | 10 VIAL in 1 BOX (50419-150-57) > 1 mL in 1 VIAL |
NDC Code | 50419-150-57 |
Proprietary Name | Refludan |
Package Description | 10 VIAL in 1 BOX (50419-150-57) > 1 mL in 1 VIAL |
Product NDC | 50419-150 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | lepirudin |
Dosage Form Name | POWDER |
Route Name | INTRAVENOUS |
Start Marketing Date | 20070309 |
Marketing Category Name | NDA |
Labeler Name | Bayer HealthCare Pharmaceuticals Inc. |
Substance Name | LEPIRUDIN |
Strength Number | 50 |
Strength Unit | mg/mL |
Pharmaceutical Classes | Anti-coagulant [EPC],Direct Thrombin Inhibitor [EPC],Thrombin Inhibitors [MoA] |