"35573-433-30" National Drug Code (NDC)

Ketoconazole 30 TABLET in 1 BOTTLE (35573-433-30)
(Burel Pharmaceuticals, LLC)

NDC Code35573-433-30
Package Description30 TABLET in 1 BOTTLE (35573-433-30)
Product NDC35573-433
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameKetoconazole
Non-Proprietary NameKetoconazole
Dosage FormTABLET
UsageORAL
Start Marketing Date20200410
Marketing Category NameANDA
Application NumberANDA075912
ManufacturerBurel Pharmaceuticals, 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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