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"53002-1381-1" National Drug Code (NDC)

Ketoconazole 120 mL in 1 BOTTLE (53002-1381-1)
(RPK Pharmaceuticals, Inc.)

NDC Code53002-1381-1
Package Description120 mL in 1 BOTTLE (53002-1381-1)
Product NDC53002-1381
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameKetoconazole
Non-Proprietary NameKetoconazole
Dosage FormSHAMPOO, SUSPENSION
UsageTOPICAL
Start Marketing Date20100119
End Marketing Date20241231
Marketing Category NameANDA
Application NumberANDA076419
ManufacturerRPK Pharmaceuticals, Inc.
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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