"85384-0001-1" National Drug Code (NDC)

1% Ketoconazole 250 mL in 1 BOTTLE (85384-0001-1)
(TAGRID LLC)

NDC Code85384-0001-1
Package Description250 mL in 1 BOTTLE (85384-0001-1)
Product NDC85384-0001
Product Type NameHUMAN OTC DRUG
Proprietary Name1% Ketoconazole
Non-Proprietary NameKetoconazole
Dosage FormSHAMPOO
UsageTOPICAL
Start Marketing Date20250331
Marketing Category NameOTC MONOGRAPH DRUG
Application NumberM005
ManufacturerTAGRID LLC
Substance NameKETOCONAZOLE
Strength10
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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