"70518-4193-0" National Drug Code (NDC)

Fluconazole 30 POUCH in 1 BOX (70518-4193-0) / 1 TABLET in 1 POUCH (70518-4193-1)
(REMEDYREPACK INC.)

NDC Code70518-4193-0
Package Description30 POUCH in 1 BOX (70518-4193-0) / 1 TABLET in 1 POUCH (70518-4193-1)
Product NDC70518-4193
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameFluconazole
Non-Proprietary NameFluconazole
Dosage FormTABLET
UsageORAL
Start Marketing Date20240930
Marketing Category NameANDA
Application NumberANDA077253
ManufacturerREMEDYREPACK INC.
Substance NameFLUCONAZOLE
Strength100
Strength Unitmg/1
Pharmacy ClassesAzole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]

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