"53002-4400-1" National Drug Code (NDC)

Fluconazole 3 TABLET in 1 BOTTLE (53002-4400-1)
(RPK Pharmaceuticals, Inc.)

NDC Code53002-4400-1
Package Description3 TABLET in 1 BOTTLE (53002-4400-1)
Product NDC53002-4400
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameFluconazole
Non-Proprietary NameFluconazole
Dosage FormTABLET
UsageORAL
Start Marketing Date20110307
Marketing Category NameANDA
Application NumberANDA078423
ManufacturerRPK Pharmaceuticals, 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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