"69292-224-01" National Drug Code (NDC)

Ketoconazole 100 TABLET in 1 BOTTLE (69292-224-01)
(Amici Pharma Inc.)

NDC Code69292-224-01
Package Description100 TABLET in 1 BOTTLE (69292-224-01)
Product NDC69292-224
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameKetoconazole
Non-Proprietary NameKetoconazole
Dosage FormTABLET
UsageORAL
Start Marketing Date20250621
Marketing Category NameANDA
Application NumberANDA075912
ManufacturerAmici Pharma 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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