NDC 35573-433

KETOCONAZOLE

Ketoconazole

KETOCONAZOLE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Burel Pharmaceuticals, Inc.. The primary component is Ketoconazole.

Product ID35573-433_010f5ec1-e9e9-4eda-b4cf-9fb58d760c3c
NDC35573-433
Product TypeHuman Prescription Drug
Proprietary NameKETOCONAZOLE
Generic NameKetoconazole
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2020-04-10
Marketing CategoryANDA / ANDA
Application NumberANDA075912
Labeler NameBurel Pharmaceuticals, Inc.
Substance NameKETOCONAZOLE
Active Ingredient Strength200 mg/1
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 Through2021-12-31

Packaging

NDC 35573-433-02

100 TABLET in 1 BOTTLE (35573-433-02)
Marketing Start Date2020-04-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 35573-433-30 [35573043330]

KETOCONAZOLE TABLET
Marketing CategoryANDA
Application NumberANDA075912
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-04-10

NDC 35573-433-02 [35573043302]

KETOCONAZOLE TABLET
Marketing CategoryANDA
Application NumberANDA075912
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-04-10

Drug Details

Active Ingredients

IngredientStrength
KETOCONAZOLE200 mg/1

OpenFDA Data

SPL SET ID:57e81e13-b395-4dbd-b660-3038de41a838
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197853
  • UPC Code
  • 0335573433307
  • 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 "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

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