| Product NDC: | 0173-0821 |
| Proprietary Name: | ARZERRA |
| Non Proprietary Name: | ofatumumab |
| Active Ingredient(s): | 20 mg/mL & nbsp; ofatumumab |
| Administration Route(s): | INTRAVENOUS |
| Dosage Form(s): | INJECTION, SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0173-0821 |
| Labeler Name: | GlaxoSmithKline LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | BLA125326 |
| Marketing Category: | BLA |
| Start Marketing Date: | 20110722 |
| Package NDC: | 0173-0821-01 |
| Package Description: | 1 VIAL in 1 CARTON (0173-0821-01) > 50 mL in 1 VIAL |
| NDC Code | 0173-0821-01 |
| Proprietary Name | ARZERRA |
| Package Description | 1 VIAL in 1 CARTON (0173-0821-01) > 50 mL in 1 VIAL |
| Product NDC | 0173-0821 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | ofatumumab |
| Dosage Form Name | INJECTION, SOLUTION |
| Route Name | INTRAVENOUS |
| Start Marketing Date | 20110722 |
| Marketing Category Name | BLA |
| Labeler Name | GlaxoSmithKline LLC |
| Substance Name | OFATUMUMAB |
| Strength Number | 20 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes | CD20-directed Cytolytic Antibody [EPC] |