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"0378-2516-93" National Drug Code (NDC)

Fluconazole 30 TABLET in 1 BOTTLE, PLASTIC (0378-2516-93)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-2516-93
Package Description30 TABLET in 1 BOTTLE, PLASTIC (0378-2516-93)
Product NDC0378-2516
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameFluconazole
Non-Proprietary NameFluconazole
Dosage FormTABLET
UsageORAL
Start Marketing Date20130226
Marketing Category NameANDA
Application NumberANDA076351
ManufacturerMylan Pharmaceuticals Inc.
Substance NameFLUCONAZOLE
Strength100
Strength Unitmg/1
Pharmacy ClassesAzole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]

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