"52125-086-02" National Drug Code (NDC)

Ketoconazole 30 TABLET in 1 BLISTER PACK (52125-086-02)
(REMEDYREPACK INC.)

NDC Code52125-086-02
Package Description30 TABLET in 1 BLISTER PACK (52125-086-02)
Product NDC52125-086
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameKetoconazole
Non-Proprietary NameKetoconazole
Dosage FormTABLET
UsageORAL
Start Marketing Date20130315
Marketing Category NameANDA
Application NumberANDA075273
ManufacturerREMEDYREPACK INC.
Substance NameKETOCONAZOLE
Strength200
Strength Unitmg/1
Pharmacy ClassesAzole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]

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