NDC 0168-0099

ketoconazole

Ketoconazole

ketoconazole is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.. The primary component is Ketoconazole.

Product ID0168-0099_98a7b296-f095-4311-9910-af4e9eeb891a
NDC0168-0099
Product TypeHuman Prescription Drug
Proprietary Nameketoconazole
Generic NameKetoconazole
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2004-04-28
Marketing CategoryANDA / ANDA
Application NumberANDA076294
Labeler NameE. Fougera & Co. a division of Fougera Pharmaceuticals 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 FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0168-0099-15

1 TUBE in 1 CARTON (0168-0099-15) > 15 g in 1 TUBE
Marketing Start Date2004-04-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0168-0099-30 [00168009930]

ketoconazole CREAM
Marketing CategoryANDA
Application NumberANDA076294
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2004-04-28

NDC 0168-0099-15 [00168009915]

ketoconazole CREAM
Marketing CategoryANDA
Application NumberANDA076294
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2004-04-28

NDC 0168-0099-60 [00168009960]

ketoconazole CREAM
Marketing CategoryANDA
Application NumberANDA076294
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2004-04-28

Drug Details

Active Ingredients

IngredientStrength
KETOCONAZOLE20 mg/g

OpenFDA Data

SPL SET ID:cad7c647-34a9-4e4e-83b3-8d78e58f588f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 203088
  • UPC Code
  • 0301680099156
  • Pharmacological Class

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

    NDC Crossover Matching brand name "ketoconazole" or generic name "Ketoconazole"

    NDCBrand NameGeneric Name
    0093-0900KetoconazoleKetoconazole
    0093-3219KetoconazoleKetoconazole
    0168-0099ketoconazoleketoconazole
    0378-0261Ketoconazoleketoconazole
    0713-0671KetoconazoleKetoconazole
    10147-0750KETOCONAZOLEketoconazole
    16714-955KetoconazoleKetoconazole
    21695-554KetoconazoleKetoconazole
    21695-555KetoconazoleKetoconazole
    21695-556KetoconazoleKetoconazole
    21695-562KetoconazoleKetoconazole
    21922-025KetoconazoleKetoconazole Cream, 2%
    33261-739KetoconazoleKetoconazole
    35573-433KETOCONAZOLEketoconazole
    43063-036Ketoconazoleketoconazole
    43063-882KetoconazoleKetoconazole
    45802-465KetoconazoleKetoconazole
    45802-532ketoconazoleketoconazole
    50090-0719ketoconazoleketoconazole
    50090-0720ketoconazoleketoconazole
    68071-1614KetoconazoleKetoconazole
    68071-1743KetoconazoleKetoconazole
    68071-1735KetoconazoleKetoconazole
    68071-1709KetoconazoleKetoconazole
    68071-4012KetoconazoleKetoconazole
    68084-552KetoconazoleKetoconazole
    68151-2713KetoconazoleKetoconazole
    68258-3998KetoconazoleKetoconazole
    68788-9708KetoconazoleKetoconazole
    68788-9903KetoconazoleKetoconazole
    68788-9117KetoconazoleKetoconazole
    68788-9915KetoconazoleKetoconazole
    70518-0915KetoconazoleKetoconazole
    70518-1637ketoconazoleketoconazole
    71205-105KetoconazoleKetoconazole
    71085-008KetoconazoleKetoconazole
    71335-0439KetoconazoleKetoconazole
    50090-1220KetoconazoleKetoconazole
    50090-1524KetoconazoleKetoconazole
    50090-3207KetoconazoleKetoconazole
    50090-1992KetoconazoleKetoconazole
    50090-1675KetoconazoleKetoconazole
    50090-3288KetoconazoleKetoconazole
    50090-3299KetoconazoleKetoconazole
    50436-4448ketoconazoleketoconazole
    51672-4026KetoconazoleKetoconazole
    51672-1298KetoconazoleKetoconazole
    53217-015KetoconazoleKetoconazole
    53002-8150KetoconazoleKetoconazole
    53808-0842KetoconazoleKetoconazole

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