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    NDC 59148-0053-98 Nuedexta 20; 10 mg/1; mg/1 Details

    Nuedexta 20; 10 mg/1; mg/1

    Nuedexta is a ORAL CAPSULE, GELATIN COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Otsuka America Pharmaceutical, Inc. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE.

    Product Information

    NDC 59148-0053
    Product ID 59148-053_99646f6f-58d9-4f4b-a17f-f4d43288ff4a
    Associated GPIs
    GCN Sequence Number n/a
    GCN Sequence Number Description n/a
    HIC3 n/a
    HIC3 Description n/a
    GCN n/a
    HICL Sequence Number n/a
    HICL Sequence Number Description n/a
    Brand/Generic n/a
    Proprietary Name Nuedexta
    Proprietary Name Suffix n/a
    Non-Proprietary Name dextromethorphan hydrobromide and quinidine sulfate
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form CAPSULE, GELATIN COATED
    Route ORAL
    Active Ingredient Strength 20; 10
    Active Ingredient Units mg/1; mg/1
    Substance Name DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE
    Labeler Name Otsuka America Pharmaceutical, Inc
    Pharmaceutical Class Antiarrhythmic [EPC], Cytochrome P450 2D6 Inhibitor [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA021879
    Listing Certified Through 2024-12-31

    Package

    NDC 59148-0053-98 (59148005398)

    NDC Package Code 59148-053-98
    Billing NDC 59148005398
    Package 4 CARTON in 1 BOX (59148-053-98) / 1 BOTTLE in 1 CARTON (59148-053-07) / 13 CAPSULE, GELATIN COATED in 1 BOTTLE
    Marketing Start Date 2023-01-03
    NDC Exclude Flag N
    Pricing Information N/A
    << 59148-0053-16 59148-0070-91 >>

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