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"53002-8151-1" National Drug Code (NDC)

Ketoconazole 1 TUBE in 1 CARTON (53002-8151-1) / 15 g in 1 TUBE
(RPK Pharmaceuticals, Inc.)

NDC Code53002-8151-1
Package Description1 TUBE in 1 CARTON (53002-8151-1) / 15 g in 1 TUBE
Product NDC53002-8151
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameKetoconazole
Non-Proprietary NameKetoconazole
Dosage FormCREAM
UsageTOPICAL
Start Marketing Date20190208
Marketing Category NameANDA
Application NumberANDA075581
ManufacturerRPK Pharmaceuticals, Inc.
Substance NameKETOCONAZOLE
Strength20
Strength Unitmg/g
Pharmacy ClassesAzole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]

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