"70518-2831-1" National Drug Code (NDC)

Ketoconazole 7 TABLET in 1 BOTTLE, PLASTIC (70518-2831-1)
(REMEDYREPACK INC.)

NDC Code70518-2831-1
Package Description7 TABLET in 1 BOTTLE, PLASTIC (70518-2831-1)
Product NDC70518-2831
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameKetoconazole
Non-Proprietary NameKetoconazole
Dosage FormTABLET
UsageORAL
Start Marketing Date20200810
Marketing Category NameANDA
Application NumberANDA075912
ManufacturerREMEDYREPACK INC.
Substance NameKETOCONAZOLE
Strength200
Strength Unitmg/1
Pharmacy ClassesAzole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]

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