"70685-001-01" National Drug Code (NDC)

Ketoconazole 30 TABLET in 1 BOTTLE (70685-001-01)
(Esjay Pharma LLC)

NDC Code70685-001-01
Package Description30 TABLET in 1 BOTTLE (70685-001-01)
Product NDC70685-001
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameKetoconazole
Non-Proprietary NameKetoconazole
Dosage FormTABLET
UsageORAL
Start Marketing Date20250910
Marketing Category NameANDA
Application NumberANDA219129
ManufacturerEsjay Pharma LLC
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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