"59676-040-56" National Drug Code (NDC)

Balversa 1 BOTTLE in 1 CARTON (59676-040-56) / 56 TABLET, FILM COATED in 1 BOTTLE
(Janssen Products LP)

NDC Code59676-040-56
Package Description1 BOTTLE in 1 CARTON (59676-040-56) / 56 TABLET, FILM COATED in 1 BOTTLE
Product NDC59676-040
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameBalversa
Non-Proprietary NameErdafitinib
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20190412
Marketing Category NameNDA
Application NumberNDA212018
ManufacturerJanssen Products LP
Substance NameERDAFITINIB
Strength4
Strength Unitmg/1
Pharmacy ClassesCytochrome P450 3A4 Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Fibroblast Growth Factor Receptor Inhibitors [MoA], Kinase Inhibitor [EPC], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]

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