| Product NDC: | 59676-101 |
| Proprietary Name: | OKT3 |
| Non Proprietary Name: | muromonab-CD3 |
| Active Ingredient(s): | 5 mg/5mL & nbsp; muromonab-CD3 |
| Administration Route(s): | INTRAVENOUS |
| Dosage Form(s): | INJECTION, SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 59676-101 |
| Labeler Name: | Centocor Ortho Biotech Products, L.P. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | BLA103463 |
| Marketing Category: | BLA |
| Start Marketing Date: | 19860719 |
| Package NDC: | 59676-101-01 |
| Package Description: | 5 AMPULE in 1 CARTON (59676-101-01) > 5 mL in 1 AMPULE (59676-101-00) |
| NDC Code | 59676-101-01 |
| Proprietary Name | OKT3 |
| Package Description | 5 AMPULE in 1 CARTON (59676-101-01) > 5 mL in 1 AMPULE (59676-101-00) |
| Product NDC | 59676-101 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | muromonab-CD3 |
| Dosage Form Name | INJECTION, SOLUTION |
| Route Name | INTRAVENOUS |
| Start Marketing Date | 19860719 |
| Marketing Category Name | BLA |
| Labeler Name | Centocor Ortho Biotech Products, L.P. |
| Substance Name | MUROMONAB-CD3 |
| Strength Number | 5 |
| Strength Unit | mg/5mL |
| Pharmaceutical Classes | CD3 Blocker Immunosuppressant [EPC],CD3 Receptor Antagonists [MoA],CD3-directed Antibody Interactions [MoA],Decreased Immunologic Activity [PE] |