Product NDC: | 25682-001 |
Proprietary Name: | Soliris |
Non Proprietary Name: | eculizumab |
Active Ingredient(s): | 300 mg/30mL & nbsp; eculizumab |
Administration Route(s): | INTRAVENOUS |
Dosage Form(s): | INJECTION, SOLUTION, CONCENTRATE |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 25682-001 |
Labeler Name: | Alexion Pharmaceuticals, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | BLA125166 |
Marketing Category: | BLA |
Start Marketing Date: | 20070402 |
Package NDC: | 25682-001-01 |
Package Description: | 1 VIAL in 1 CARTON (25682-001-01) > 30 mL in 1 VIAL |
NDC Code | 25682-001-01 |
Proprietary Name | Soliris |
Package Description | 1 VIAL in 1 CARTON (25682-001-01) > 30 mL in 1 VIAL |
Product NDC | 25682-001 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | eculizumab |
Dosage Form Name | INJECTION, SOLUTION, CONCENTRATE |
Route Name | INTRAVENOUS |
Start Marketing Date | 20070402 |
Marketing Category Name | BLA |
Labeler Name | Alexion Pharmaceuticals, Inc. |
Substance Name | ECULIZUMAB |
Strength Number | 300 |
Strength Unit | mg/30mL |
Pharmaceutical Classes | Complement Inhibitor [EPC],Complement Inhibitors [MoA] |