"57894-505-05" National Drug Code (NDC)

Darzalex Iv 1 VIAL, SINGLE-DOSE in 1 BOX (57894-505-05) / 5 mL in 1 VIAL, SINGLE-DOSE
(Janssen Biotech, Inc.)

NDC Code57894-505-05
Package Description1 VIAL, SINGLE-DOSE in 1 BOX (57894-505-05) / 5 mL in 1 VIAL, SINGLE-DOSE
Product NDC57894-505
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameDarzalex Iv
Non-Proprietary NameDaratumumab
Dosage FormINJECTION, SOLUTION, CONCENTRATE
UsageINTRAVENOUS
Start Marketing Date20211015
Marketing Category NameBLA
Application NumberBLA761036
ManufacturerJanssen Biotech, Inc.
Substance NameDARATUMUMAB
Strength100
Strength Unitmg/5mL
Pharmacy ClassesAntibodies, Monoclonal [CS], CD38-directed Antibody Interactions [MoA], CD38-directed Cytolytic Antibody [EPC]

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