"0469-0625-99" National Drug Code (NDC)

Xtandi 1 BOTTLE in 1 CARTON (0469-0625-99) / 120 TABLET in 1 BOTTLE
(Astellas Pharma US, Inc.)

NDC Code0469-0625-99
Package Description1 BOTTLE in 1 CARTON (0469-0625-99) / 120 TABLET in 1 BOTTLE
Product NDC0469-0625
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameXtandi
Non-Proprietary NameEnzalutamide
Dosage FormTABLET
UsageORAL
Start Marketing Date20200804
Marketing Category NameNDA
Application NumberNDA213674
ManufacturerAstellas Pharma US, Inc.
Substance NameENZALUTAMIDE
Strength40
Strength Unitmg/1
Pharmacy ClassesAndrogen Receptor Antagonists [MoA], Androgen Receptor Inhibitor [EPC], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA]

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