Search by Drug Name or NDC

    NDC 71205-0105-72 Ketoconazole 20 mg/mL Details

    Ketoconazole 20 mg/mL

    Ketoconazole is a TOPICAL SHAMPOO, SUSPENSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Proficient Rx LP. The primary component is KETOCONAZOLE.

    Product Information

    NDC 71205-0105
    Product ID 71205-105_c7f1508c-9478-4379-9c50-4d5a6b8cdcef
    Associated GPIs 90154045004510
    GCN Sequence Number 015568
    GCN Sequence Number Description ketoconazole SHAMPOO 2 % TOPICAL
    HIC3 Q5F
    HIC3 Description TOPICAL ANTIFUNGALS
    GCN 31271
    HICL Sequence Number 004132
    HICL Sequence Number Description KETOCONAZOLE
    Brand/Generic Generic
    Proprietary Name Ketoconazole
    Proprietary Name Suffix n/a
    Non-Proprietary Name Ketoconazole
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form SHAMPOO, SUSPENSION
    Route TOPICAL
    Active Ingredient Strength 20
    Active Ingredient Units mg/mL
    Substance Name KETOCONAZOLE
    Labeler Name Proficient Rx LP
    Pharmaceutical Class Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA076942
    Listing Certified Through 2024-12-31

    Package

    NDC 71205-0105-72 (71205010572)

    NDC Package Code 71205-105-72
    Billing NDC 71205010572
    Package 120 mL in 1 BOTTLE, PLASTIC (71205-105-72)
    Marketing Start Date 2018-09-04
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL cb1908da-443d-40b8-b8c7-b115bc2d37e0 Details

    Revised: 11/2022