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    NDC 63629-1975-01 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate 5; 5; 5; 5 mg/1; mg/1; mg/1; mg/1 Details

    Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate 5; 5; 5; 5 mg/1; mg/1; mg/1; mg/1

    Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate is a ORAL CAPSULE, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE.

    Product Information

    NDC 63629-1975
    Product ID 63629-1975_5d0090ce-5984-422c-b3e2-360639e25855
    Associated GPIs 61109902107020
    GCN Sequence Number 048702
    GCN Sequence Number Description dextroamphetamine/amphetamine CAP ER 24H 20 MG ORAL
    HIC3 J5B
    HIC3 Description ADRENERGICS, AROMATIC, NON-CATECHOLAMINE
    GCN 14636
    HICL Sequence Number 013449
    HICL Sequence Number Description DEXTROAMPHETAMINE SULF-SACCHARATE/AMPHETAMINE SULF-ASPARTATE
    Brand/Generic Generic
    Proprietary Name Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate
    Proprietary Name Suffix n/a
    Non-Proprietary Name Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form CAPSULE, EXTENDED RELEASE
    Route ORAL
    Active Ingredient Strength 5; 5; 5; 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 Bryant Ranch Prepack
    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 ANDA205401
    Listing Certified Through 2025-12-31

    Package

    NDC 63629-1975-01 (63629197501)

    NDC Package Code 63629-1975-1
    Billing NDC 63629197501
    Package 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-1975-1)
    Marketing Start Date 2021-12-21
    NDC Exclude Flag N
    Pricing Information N/A