"70518-2315-0" National Drug Code (NDC)

Ketoconazole 30 TABLET in 1 BLISTER PACK (70518-2315-0)
(REMEDYREPACK INC.)

NDC Code70518-2315-0
Package Description30 TABLET in 1 BLISTER PACK (70518-2315-0)
Product NDC70518-2315
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameKetoconazole
Non-Proprietary NameKetoconazole
Dosage FormTABLET
UsageORAL
Start Marketing Date20190916
Marketing Category NameANDA
Application NumberANDA210457
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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