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    NDC 75826-0121-10 Dextroamphetamine Sulfate 5 mg/1 Details

    Dextroamphetamine Sulfate 5 mg/1

    Dextroamphetamine Sulfate is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Winder Laboratories LLC. The primary component is DEXTROAMPHETAMINE SULFATE.

    Product Information

    NDC 75826-0121
    Product ID 75826-121_dabda9d0-19c6-519e-e053-2a95a90adb5e
    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 Dextroamphetamine Sulfate
    Proprietary Name Suffix n/a
    Non-Proprietary Name Dextroamphetamine Sulfate
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength 5
    Active Ingredient Units mg/1
    Substance Name DEXTROAMPHETAMINE SULFATE
    Labeler Name Winder Laboratories LLC
    Pharmaceutical Class Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
    DEA Schedule CII
    Marketing Category ANDA
    Application Number ANDA212160
    Listing Certified Through 2024-12-31

    Package

    NDC 75826-0121-10 (75826012110)

    NDC Package Code 75826-121-10
    Billing NDC 75826012110
    Package 100 TABLET in 1 BOTTLE, PLASTIC (75826-121-10)
    Marketing Start Date 2021-12-06
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL ca1a8890-0675-4c9c-9716-6c28f975d827 Details

    Revised: 3/2022