"0054-0003-85" National Drug Code (NDC)

Fluconazole 1400 mL in 1 BOTTLE, PLASTIC (0054-0003-85)
(Hikma Pharmaceuticals USA Inc.)

NDC Code0054-0003-85
Package Description1400 mL in 1 BOTTLE, PLASTIC (0054-0003-85)
Product NDC0054-0003
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameFluconazole
Non-Proprietary NameFluconazole
Dosage FormPOWDER, FOR SUSPENSION
UsageORAL
Start Marketing Date20040729
End Marketing Date20210531
Marketing Category NameANDA
Application NumberANDA076246
ManufacturerHikma Pharmaceuticals USA Inc.
Substance NameFLUCONAZOLE
Strength40
Strength Unitmg/mL
Pharmacy ClassesAzole Antifungal [EPC],Azoles [CS],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]

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