"43598-055-04" National Drug Code (NDC)

Nilotinib 120 CAPSULE in 1 BOTTLE (43598-055-04)
(Dr. Reddy's Laboratories Inc)

NDC Code43598-055-04
Package Description120 CAPSULE in 1 BOTTLE (43598-055-04)
Product NDC43598-055
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameNilotinib
Non-Proprietary NameNilotinib
Dosage FormCAPSULE
UsageORAL
Start Marketing Date20251119
Marketing Category NameANDA
Application NumberANDA218350
ManufacturerDr. Reddy's Laboratories Inc
Substance NameNILOTINIB HYDROCHLORIDE MONOHYDRATE
Strength50
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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