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    NDC 52343-0162-01 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 2.5; 2.5; 2.5; 2.5 mg/1; mg/1; mg/1; mg/1 Details

    Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 2.5; 2.5; 2.5; 2.5 mg/1; mg/1; mg/1; mg/1

    Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by ACETRIS HEALTH, LLC. The primary component is AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE.

    Product Information

    NDC 52343-0162
    Product ID 52343-162_d39eae2c-d9c8-4c31-96e9-e02e2b310def
    Associated GPIs 61109902100310
    GCN Sequence Number 005000
    GCN Sequence Number Description dextroamphetamine/amphetamine TABLET 10 MG ORAL
    HIC3 J5B
    HIC3 Description ADRENERGICS, AROMATIC, NON-CATECHOLAMINE
    GCN 56971
    HICL Sequence Number 013449
    HICL Sequence Number Description DEXTROAMPHETAMINE SULF-SACCHARATE/AMPHETAMINE SULF-ASPARTATE
    Brand/Generic Generic
    Proprietary Name Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate
    Proprietary Name Suffix n/a
    Non-Proprietary Name Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength 2.5; 2.5; 2.5; 2.5
    Active Ingredient Units mg/1; mg/1; mg/1; mg/1
    Substance Name AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
    Labeler Name ACETRIS HEALTH, LLC
    Pharmaceutical Class Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervo
    DEA Schedule CII
    Marketing Category ANDA
    Application Number ANDA202424
    Listing Certified Through 2023-12-31

    Package

    NDC 52343-0162-01 (52343016201)

    NDC Package Code 52343-162-01
    Billing NDC 52343016201
    Package 100 TABLET in 1 BOTTLE (52343-162-01)
    Marketing Start Date 2017-11-27
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 7a72e13a-33b1-48f2-b036-7e08cb7b65ff Details

    Revised: 1/2019