NDC 50458-680

Nizoral

Ketoconazole

Nizoral is a Topical Shampoo in the Human Prescription Drug category. It is labeled and distributed by Janssen Pharmaceuticals, Inc.. The primary component is Ketoconazole.

Product ID50458-680_06febdbd-2183-4776-8243-754a5ca16211
NDC50458-680
Product TypeHuman Prescription Drug
Proprietary NameNizoral
Generic NameKetoconazole
Dosage FormShampoo
Route of AdministrationTOPICAL
Marketing Start Date1990-08-31
Marketing CategoryNDA / NDA
Application NumberNDA019927
Labeler NameJanssen Pharmaceuticals, Inc.
Substance NameKETOCONAZOLE
Active Ingredient Strength20 mg/mL
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 50458-680-08

1 BOTTLE in 1 CARTON (50458-680-08) > 120 mL in 1 BOTTLE
Marketing Start Date1990-08-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50458-680-08 [50458068008]

Nizoral SHAMPOO
Marketing CategoryNDA
Application NumberNDA019927
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1990-08-31
Marketing End Date2020-04-30

Drug Details

Active Ingredients

IngredientStrength
KETOCONAZOLE20 mg/mL

OpenFDA Data

SPL SET ID:efbc6388-90ce-11de-b92c-8b7156d89593
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 106336
  • 206978
  • Pharmacological Class

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

    Medicade Reported Pricing

    50458068008 NIZORAL 2% SHAMPOO

    Pricing Unit: ML | Drug Type:

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

    NDCBrand NameGeneric Name
    50458-680NizoralNizoral
    55505-191NizoralNizoral
    55505-192NizoralNizoral
    0378-8136EXTINAketoconazole
    40076-051EXTINAketoconazole
    0093-0900KetoconazoleKetoconazole
    0093-3219KetoconazoleKetoconazole
    0168-0099ketoconazoleketoconazole
    0378-0261Ketoconazoleketoconazole
    0713-0671KetoconazoleKetoconazole
    10147-0750KETOCONAZOLEketoconazole
    16714-955KetoconazoleKetoconazole
    21695-554KetoconazoleKetoconazole
    21695-555KetoconazoleKetoconazole
    21695-556KetoconazoleKetoconazole
    21695-562KetoconazoleKetoconazole
    33261-739KetoconazoleKetoconazole
    35573-433KETOCONAZOLEketoconazole
    43063-036Ketoconazoleketoconazole
    43063-882KetoconazoleKetoconazole
    45802-465KetoconazoleKetoconazole
    45802-532ketoconazoleketoconazole
    50090-0719ketoconazoleketoconazole
    50090-0720ketoconazoleketoconazole
    50090-1220KetoconazoleKetoconazole
    43538-530Ketodanketoconazole
    43538-531Ketodanketoconazole
    16110-080Xolegelketoconazole

    Trademark Results [Nizoral]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    NIZORAL
    NIZORAL
    97728117 not registered Live/Pending
    Kramer Consumer Healthcare, Inc.
    2022-12-22
    NIZORAL
    NIZORAL
    90726591 not registered Live/Pending
    Kramer Consumer Healthcare, Inc.
    2021-05-21
    NIZORAL
    NIZORAL
    73388680 1278609 Live/Registered
    Johnson & Johnson
    1982-09-24
    NIZORAL
    NIZORAL
    73257535 1170891 Dead/Cancelled
    Johnson & Johnson
    1980-04-10

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.