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    NDC 70370-3050-05 ONGENTYS 50 mg/1 Details

    ONGENTYS 50 mg/1

    ONGENTYS is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Neurocrine Biosciences, Inc.. The primary component is OPICAPONE.

    Product Information

    NDC 70370-3050
    Product ID 70370-3050_d2eba1fb-35ba-40ed-802b-a9c46e36178b
    Associated GPIs 73153060000120
    GCN Sequence Number 079348
    GCN Sequence Number Description opicapone CAPSULE 50 MG ORAL
    HIC3 H6A
    HIC3 Description ANTIPARKINSONISM DRUGS,OTHER
    GCN 45838
    HICL Sequence Number 045536
    HICL Sequence Number Description OPICAPONE
    Brand/Generic Brand
    Proprietary Name ONGENTYS
    Proprietary Name Suffix n/a
    Non-Proprietary Name opicapone
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form CAPSULE
    Route ORAL
    Active Ingredient Strength 50
    Active Ingredient Units mg/1
    Substance Name OPICAPONE
    Labeler Name Neurocrine Biosciences, Inc.
    Pharmaceutical Class Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA212489
    Listing Certified Through 2024-12-31

    Package

    NDC 70370-3050-05 (70370305005)

    NDC Package Code 70370-3050-5
    Billing NDC 70370305005
    Package 7 CAPSULE in 1 BOTTLE (70370-3050-5)
    Marketing Start Date 2020-10-26
    NDC Exclude Flag N
    Pricing Information N/A