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"53002-5198-2" National Drug Code (NDC)

Fluconazole 1 BLISTER PACK in 1 CARTON (53002-5198-2) / 1 TABLET in 1 BLISTER PACK
(RPK Pharmaceuticals, Inc.)

NDC Code53002-5198-2
Package Description1 BLISTER PACK in 1 CARTON (53002-5198-2) / 1 TABLET in 1 BLISTER PACK
Product NDC53002-5198
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameFluconazole
Non-Proprietary NameFluconazole
Dosage FormTABLET
UsageORAL
Start Marketing Date20201120
Marketing Category NameANDA
Application NumberANDA077253
ManufacturerRPK Pharmaceuticals, Inc.
Substance NameFLUCONAZOLE
Strength150
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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