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    NDC 42806-0336-01 Molindone Hydrochloride 5 mg/1 Details

    Molindone Hydrochloride 5 mg/1

    Molindone Hydrochloride is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by EPIC PHARMA, LLC. The primary component is MOLINDONE HYDROCHLORIDE.

    Product Information

    NDC 42806-0336
    Product ID 42806-336_b957cd51-22e2-4944-9653-704030fd0dfb
    Associated GPIs 59160050100305
    GCN Sequence Number 003990
    GCN Sequence Number Description molindone HCl TABLET 5 MG ORAL
    HIC3 H7S
    HIC3 Description ANTIPSYCHOTICS,DOPAMINE ANTAGONST,DIHYDROINDOLONES
    GCN 15653
    HICL Sequence Number 001666
    HICL Sequence Number Description MOLINDONE HCL
    Brand/Generic Generic
    Proprietary Name Molindone Hydrochloride
    Proprietary Name Suffix n/a
    Non-Proprietary Name Molindone Hydrochloride
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength 5
    Active Ingredient Units mg/1
    Substance Name MOLINDONE HYDROCHLORIDE
    Labeler Name EPIC PHARMA, LLC
    Pharmaceutical Class Typical Antipsychotic [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA090453
    Listing Certified Through 2024-12-31

    Package

    NDC 42806-0336-01 (42806033601)

    NDC Package Code 42806-336-01
    Billing NDC 42806033601
    Package 100 TABLET in 1 BOTTLE (42806-336-01)
    Marketing Start Date 2018-10-17
    NDC Exclude Flag N
    Pricing Information N/A