NDC 0378-8136

EXTINA

Ketoconazole

EXTINA is a Topical Aerosol, Foam in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Ketoconazole.

Product ID0378-8136_6082e3cc-c1da-4df0-9937-e9fe551ecc5d
NDC0378-8136
Product TypeHuman Prescription Drug
Proprietary NameEXTINA
Generic NameKetoconazole
Dosage FormAerosol, Foam
Route of AdministrationTOPICAL
Marketing Start Date2019-01-04
Marketing CategoryNDA / NDA
Application NumberNDA021738
Labeler NameMylan 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 0378-8136-01

100 g in 1 CAN (0378-8136-01)
Marketing Start Date2019-01-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-8136-50 [00378813650]

EXTINA AEROSOL, FOAM
Marketing CategoryNDA
Application NumberNDA021738
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2019-01-04

NDC 0378-8136-01 [00378813601]

EXTINA AEROSOL, FOAM
Marketing CategoryNDA
Application NumberNDA021738
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2019-01-04

Drug Details

Active Ingredients

IngredientStrength
KETOCONAZOLE20 mg/g

OpenFDA Data

SPL SET ID:36629578-188e-434e-bac8-27784b81d50e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 729768
  • 728550

    • 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 "EXTINA" or generic name "Ketoconazole"

    NDCBrand NameGeneric Name
    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 [EXTINA]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    EXTINA
    EXTINA
    78135630 2826419 Live/Registered
    STIEFEL LABORATORIES, INC.
    2002-06-13
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