"52125-601-01" National Drug Code (NDC)

Ketoconazole 15 g in 1 TUBE (52125-601-01)
(REMEDYREPACK INC.)

NDC Code52125-601-01
Package Description15 g in 1 TUBE (52125-601-01)
Product NDC52125-601
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameKetoconazole
Non-Proprietary NameKetoconazole
Dosage FormCREAM
UsageTOPICAL
Start Marketing Date20130604
Marketing Category NameANDA
Application NumberANDA075638
ManufacturerREMEDYREPACK INC.
Substance NameKETOCONAZOLE
Strength20
Strength Unitmg/g
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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