| 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] |