| NDC Code | 57894-503-01 |
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| Package Description | 1 VIAL, SINGLE-DOSE in 1 BOX (57894-503-01) / 15 mL in 1 VIAL, SINGLE-DOSE |
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| Product NDC | 57894-503 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Darzalex Faspro |
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| Non-Proprietary Name | Daratumumab And Hyaluronidase-fihj (human Recombinant) |
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| Dosage Form | INJECTION |
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| Usage | SUBCUTANEOUS |
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| Start Marketing Date | 20200501 |
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| Marketing Category Name | BLA |
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| Application Number | BLA761145 |
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| Manufacturer | Janssen Biotech, Inc. |
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| Substance Name | DARATUMUMAB; HYALURONIDASE (HUMAN RECOMBINANT) |
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| Strength | 1800; 30000 |
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| Strength Unit | mg/15mL; U/15mL |
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| Pharmacy Classes | Antibodies, Monoclonal [CS], CD38-directed Antibody Interactions [MoA], CD38-directed Cytolytic Antibody [EPC], Endoglycosidase [EPC], Glycoside Hydrolases [CS] |
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