| Product NDC: | 0007-3261 |
| Proprietary Name: | BEXXAR |
| Non Proprietary Name: | tositumomab I-131 |
| Active Ingredient(s): | .61 mCi/mL & nbsp; tositumomab I-131 |
| Administration Route(s): | INTRAVENOUS |
| Dosage Form(s): | INJECTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0007-3261 |
| Labeler Name: | GlaxoSmithKline LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | BLA125011 |
| Marketing Category: | BLA |
| Start Marketing Date: | 20090715 |
| Package NDC: | 0007-3261-01 |
| Package Description: | 20 mL in 1 VIAL, SINGLE-USE (0007-3261-01) |
| NDC Code | 0007-3261-01 |
| Proprietary Name | BEXXAR |
| Package Description | 20 mL in 1 VIAL, SINGLE-USE (0007-3261-01) |
| Product NDC | 0007-3261 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | tositumomab I-131 |
| Dosage Form Name | INJECTION |
| Route Name | INTRAVENOUS |
| Start Marketing Date | 20090715 |
| Marketing Category Name | BLA |
| Labeler Name | GlaxoSmithKline LLC |
| Substance Name | TOSITUMOMAB I-131 |
| Strength Number | .61 |
| Strength Unit | mCi/mL |
| Pharmaceutical Classes | CD20-directed Antibody Interactions [MoA],CD20-directed Radiotherapeutic Antibody [EPC],Radiopharmaceutical Activity [MoA] |