"53217-015-01" National Drug Code (NDC)

Ketoconazole 120 mL in 1 BOTTLE, PLASTIC (53217-015-01)
(Aidarex Pharmaceuticals LLC)

NDC Code53217-015-01
Package Description120 mL in 1 BOTTLE, PLASTIC (53217-015-01)
Product NDC53217-015
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameKetoconazole
Non-Proprietary NameKetoconazole
Dosage FormSHAMPOO, SUSPENSION
UsageTOPICAL
Start Marketing Date20100119
Marketing Category NameANDA
Application NumberANDA076419
ManufacturerAidarex Pharmaceuticals LLC
Substance NameKETOCONAZOLE
Strength20
Strength Unitmg/mL
Pharmacy ClassesAzole Antifungal [EPC],Azoles [CS],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]

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