"50633-230-01" National Drug Code (NDC)

Danyelza 1 VIAL, SINGLE-DOSE in 1 CARTON (50633-230-01) / 10 mL in 1 VIAL, SINGLE-DOSE
(BTG International Inc.)

NDC Code50633-230-01
Package Description1 VIAL, SINGLE-DOSE in 1 CARTON (50633-230-01) / 10 mL in 1 VIAL, SINGLE-DOSE
Product NDC50633-230
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameDanyelza
Non-Proprietary NameNaxitamab
Dosage FormINJECTION
UsageINTRAVENOUS
Start Marketing Date20260901
Marketing Category NameBLA
Application NumberBLA761171
ManufacturerBTG International Inc.
Substance NameNAXITAMAB
Strength40
Strength Unitmg/10mL
Pharmacy ClassesGlycolipid Disialoganglioside-directed Antibody Interactions [MoA], Glycolipid Disialoganglioside-directed Antibody [EPC]

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