"0378-0261-05" National Drug Code (NDC)

Ketoconazole 500 TABLET in 1 BOTTLE, PLASTIC (0378-0261-05)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-0261-05
Package Description500 TABLET in 1 BOTTLE, PLASTIC (0378-0261-05)
Product NDC0378-0261
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameKetoconazole
Non-Proprietary NameKetoconazole
Dosage FormTABLET
UsageORAL
Start Marketing Date20000223
Marketing Category NameANDA
Application NumberANDA075597
ManufacturerMylan Pharmaceuticals 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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