"76282-790-58" National Drug Code (NDC)

Nilotinib 4 CARTON in 1 CARTON (76282-790-58) / 4 BLISTER PACK in 1 CARTON (76282-790-46) / 7 CAPSULE in 1 BLISTER PACK (76282-790-45)
(EXELAN PHARMACEUTICALS INC.)

NDC Code76282-790-58
Package Description4 CARTON in 1 CARTON (76282-790-58) / 4 BLISTER PACK in 1 CARTON (76282-790-46) / 7 CAPSULE in 1 BLISTER PACK (76282-790-45)
Product NDC76282-790
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameNilotinib
Non-Proprietary NameNilotinib
Dosage FormCAPSULE
UsageORAL
Start Marketing Date20251114
Marketing Category NameNDA
Application NumberNDA218922
ManufacturerEXELAN PHARMACEUTICALS INC.
Substance NameNILOTINIB
Strength200
Strength Unitmg/1
Pharmacy ClassesBcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Kinase Inhibitor [EPC], P-Glycoprotein Inhibitors [MoA], UGT1A1 Inhibitors [MoA]

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