NDC 16110-080

Xolegel

Ketoconazole

Xolegel is a Topical Gel in the Human Prescription Drug category. It is labeled and distributed by Almirall, Llc. The primary component is Ketoconazole.

Product ID16110-080_285472ff-4b8a-4977-94ad-0b5bd39835bf
NDC16110-080
Product TypeHuman Prescription Drug
Proprietary NameXolegel
Generic NameKetoconazole
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2006-07-28
Marketing CategoryNDA / NDA
Application NumberNDA021946
Labeler NameAlmirall, LLC
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 16110-080-45

1 TUBE in 1 CARTON (16110-080-45) > 45 g in 1 TUBE
Marketing Start Date2006-07-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 16110-080-02 [16110008002]

Xolegel GEL
Marketing CategoryNDA
Application NumberNDA021946
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-07-28
Marketing End Date2015-03-24

NDC 16110-080-45 [16110008045]

Xolegel GEL
Marketing CategoryNDA
Application NumberNDA021946
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2006-07-28

Drug Details

Active Ingredients

IngredientStrength
KETOCONAZOLE20 mg/g

OpenFDA Data

SPL SET ID:855e42bb-b57f-4772-bffa-d766ddcc46ce
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 664961
  • 647253
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    16110-080Xolegelketoconazole
    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

    Trademark Results [Xolegel]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    XOLEGEL
    XOLEGEL
    78888803 3292228 Live/Registered
    ALMIRALL, LLC
    2006-05-22
    XOLEGEL
    XOLEGEL
    77464439 not registered Dead/Abandoned
    STIEFEL LABORATORIES, INC.
    2008-05-02
    XOLEGEL
    XOLEGEL
    77035401 not registered Dead/Abandoned
    STIEFEL LABORATORIES, INC.
    2006-11-02

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