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"53002-8150-1" National Drug Code (NDC)

Ketoconazole 15 g in 1 TUBE (53002-8150-1)
(RPK Pharmaceuticals, Inc.)

NDC Code53002-8150-1
Package Description15 g in 1 TUBE (53002-8150-1)
Product NDC53002-8150
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameKetoconazole
Non-Proprietary NameKetoconazole
Dosage FormCREAM
UsageTOPICAL
Start Marketing Date20021218
Marketing Category NameANDA
Application NumberANDA075638
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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