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    NDC 64597-0301-60 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 Avanir Pharmaceuticals, Inc.. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE.

    Product Information

    NDC 64597-0301
    Product ID 64597-301_0f916cea-0d2b-4d75-8b68-25be67cbcd99
    Associated GPIs 62609902300120
    GCN Sequence Number 066871
    GCN Sequence Number Description dextromethorphan Hbr/quinidine CAPSULE 20 MG-10MG ORAL
    HIC3 H8O
    HIC3 Description PSEUDOBULBAR AFFECT (PBA) AGENTS, NMDA ANTAGONISTS
    GCN 29290
    HICL Sequence Number 037278
    HICL Sequence Number Description DEXTROMETHORPHAN HBR/QUINIDINE SULFATE
    Brand/Generic Brand
    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 Avanir Pharmaceuticals, 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 64597-0301-60 (64597030160)

    NDC Package Code 64597-301-60
    Billing NDC 64597030160
    Package 60 CAPSULE, GELATIN COATED in 1 BOTTLE (64597-301-60)
    Marketing Start Date 2010-12-01
    NDC Exclude Flag N
    Pricing Information
    Price Per Unit 25.1247
    Pricing Unit EA
    Effective Date 2024-01-15
    NDC Description NUEDEXTA 20-10 MG CAPSULE
    Pharmacy Type Indicator C/I
    OTC N
    Explanation Code 4
    Classification for Rate Setting B
    As of Date 2024-02-21
    This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis