NDC 68258-3998

Ketoconazole

Ketoconazole

Ketoconazole is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Dispensing Solutions, Inc.. The primary component is Ketoconazole.

Product ID68258-3998_3f184545-ae45-4fcb-a640-930401accb0b
NDC68258-3998
Product TypeHuman Prescription Drug
Proprietary NameKetoconazole
Generic NameKetoconazole
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2002-12-18
Marketing CategoryANDA / ANDA
Application NumberANDA075638
Labeler NameDispensing Solutions, Inc.
Substance NameKETOCONAZOLE
Active Ingredient Strength20 mg/g
Pharm ClassesAzole Antifungal [EPC],Azoles [CS],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 68258-3998-3

1 TUBE in 1 CARTON (68258-3998-3) > 30 g in 1 TUBE
Marketing Start Date2002-12-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68258-3998-3 [68258399803]

Ketoconazole CREAM
Marketing CategoryANDA
Application NumberANDA075638
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2002-12-18
Inactivation Date2019-11-13

Drug Details

Active Ingredients

IngredientStrength
KETOCONAZOLE20 mg/g

OpenFDA Data

SPL SET ID:c23a27a2-e2e5-4a93-a96a-1f0248286f43
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 203088
  • Pharmacological Class

    • Azole Antifungal [EPC]
    • Azoles [CS]
    • Cytochrome P450 3A4 Inhibitors [MoA]
    • Cytochrome P450 3A5 Inhibitors [MoA]
    • P-Glycoprotein Inhibitors [MoA]