"68382-224-01" National Drug Code (NDC)

Bicalutamide 100 TABLET, FILM COATED in 1 BOTTLE (68382-224-01)
(Zydus Pharmaceuticals USA Inc.)

NDC Code68382-224-01
Package Description100 TABLET, FILM COATED in 1 BOTTLE (68382-224-01)
Product NDC68382-224
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameBicalutamide
Non-Proprietary NameBicalutamide
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20090706
Marketing Category NameANDA
Application NumberANDA079089
ManufacturerZydus Pharmaceuticals USA Inc.
Substance NameBICALUTAMIDE
Strength50
Strength Unitmg/1
Pharmacy ClassesAndrogen Receptor Antagonists [MoA], Androgen Receptor Inhibitor [EPC]

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