NDC 50580-895

Nizoral A-D

Ketoconazole

Nizoral A-D is a Topical Shampoo in the Human Otc Drug category. It is labeled and distributed by Johnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division. The primary component is Ketoconazole.

Product ID50580-895_490715fc-184d-4fcf-9e27-4209db5d18da
NDC50580-895
Product TypeHuman Otc Drug
Proprietary NameNizoral A-D
Generic NameKetoconazole
Dosage FormShampoo
Route of AdministrationTOPICAL
Marketing Start Date1999-04-01
Marketing CategoryNDA / NDA
Application NumberNDA020310
Labeler NameJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Substance NameKETOCONAZOLE
Active Ingredient Strength10 mg/mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 50580-895-04

1 BOTTLE in 1 CARTON (50580-895-04) > 125 mL in 1 BOTTLE
Marketing Start Date1999-04-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50580-895-14 [50580089514]

Nizoral A-D SHAMPOO
Marketing CategoryNDA
Application NumberNDA020310
Product TypeHUMAN OTC DRUG
Marketing Start Date1999-04-01

NDC 50580-895-04 [50580089504]

Nizoral A-D SHAMPOO
Marketing CategoryNDA
Application NumberNDA020310
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date1999-04-01

NDC 50580-895-07 [50580089507]

Nizoral A-D SHAMPOO
Marketing CategoryNDA
Application NumberNDA020310
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date1999-04-01

NDC 50580-895-15 [50580089515]

Nizoral A-D SHAMPOO
Marketing CategoryNDA
Application NumberNDA020310
Product TypeHUMAN OTC DRUG
Marketing Start Date1999-04-01

Drug Details

Active Ingredients

IngredientStrength
KETOCONAZOLE10 mg/mL

OpenFDA Data

SPL SET ID:0ae873af-1307-4cfb-b508-988e08bd8499
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 240812
  • 608844
  • NDC Crossover Matching brand name "Nizoral A-D" or generic name "Ketoconazole"

    NDCBrand NameGeneric Name
    50580-895Nizoral A-DNizoral A-D
    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
    98656700 not registered Live/Pending
    KRAMER CONSUMER HEALTHCARE, INC.
    2024-07-19
    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.