| NDC Code | 0008-4510-01 |
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| Package Description | 1 VIAL, SINGLE-DOSE in 1 CARTON (0008-4510-01) / 5 mL in 1 VIAL, SINGLE-DOSE |
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| Product NDC | 0008-4510 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Mylotarg |
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| Non-Proprietary Name | Gemtuzumab Ozogamicin |
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| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
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| Usage | INTRAVENOUS |
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| Start Marketing Date | 20170907 |
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| Marketing Category Name | BLA |
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| Application Number | BLA761060 |
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| Manufacturer | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. |
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| Substance Name | GEMTUZUMAB OZOGAMICIN |
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| Strength | 5 |
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| Strength Unit | mg/5mL |
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| Pharmacy Classes | CD33-directed Antibody Interactions [MoA], CD33-directed Immunoconjugate [EPC] |
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