"65162-087-34" National Drug Code (NDC)

Itraconazole 10 CUP, UNIT-DOSE in 1 TRAY (65162-087-34) / 10 mL in 1 CUP, UNIT-DOSE (65162-087-13)
(Amneal Pharmaceuticals LLC)

NDC Code65162-087-34
Package Description10 CUP, UNIT-DOSE in 1 TRAY (65162-087-34) / 10 mL in 1 CUP, UNIT-DOSE (65162-087-13)
Product NDC65162-087
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameItraconazole
Non-Proprietary NameItraconazole
Dosage FormSOLUTION
UsageORAL
Start Marketing Date20140430
Marketing Category NameANDA
Application NumberANDA205573
ManufacturerAmneal Pharmaceuticals LLC
Substance NameITRACONAZOLE
Strength10
Strength Unitmg/mL
Pharmacy ClassesAzole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]

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