NDC 64380-827

KETOCONAZOLE

Ketoconazole

KETOCONAZOLE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Strides Pharma Science Limited. The primary component is Ketoconazole.

Product ID64380-827_56702bb6-bad0-4294-a230-89971f594281
NDC64380-827
Product TypeHuman Prescription Drug
Proprietary NameKETOCONAZOLE
Generic NameKetoconazole
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-06-26
Marketing CategoryANDA / ANDA
Application NumberANDA210457
Labeler NameStrides Pharma Science Limited
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 Through2023-12-31

Packaging

NDC 64380-827-06

100 TABLET in 1 BOTTLE (64380-827-06)
Marketing Start Date2018-06-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 64380-827-06 [64380082706]

KETOCONAZOLE TABLET
Marketing CategoryANDA
Application NumberANDA210457
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-06-26

NDC 64380-827-07 [64380082707]

KETOCONAZOLE TABLET
Marketing CategoryANDA
Application NumberANDA210457
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-06-26

Drug Details

Active Ingredients

IngredientStrength
KETOCONAZOLE200 mg/1

OpenFDA Data

SPL SET ID:6d4be760-c723-4f54-a854-12c61cf91703
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197853
  • UPC Code
  • 0364380827061
  • 0364380827078
  • 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]

    Medicade Reported Pricing

    64380082706 KETOCONAZOLE 200 MG TABLET

    Pricing Unit: EA | Drug Type:

    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

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