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    NDC 42806-0337-01 Molindone Hydrochloride 10 mg/1 Details

    Molindone Hydrochloride 10 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 42806-0337
    Product ID 42806-337_b957cd51-22e2-4944-9653-704030fd0dfb
    Associated GPIs 59160050100310
    GCN Sequence Number 003987
    GCN Sequence Number Description molindone HCl TABLET 10 MG ORAL
    HIC3 H7S
    HIC3 Description ANTIPSYCHOTICS,DOPAMINE ANTAGONST,DIHYDROINDOLONES
    GCN 15650
    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 10
    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 42806-0337-01 (42806033701)

    NDC Package Code 42806-337-01
    Billing NDC 42806033701
    Package 100 TABLET in 1 BOTTLE (42806-337-01)
    Marketing Start Date 2018-10-17
    NDC Exclude Flag N
    Pricing Information N/A