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    NDC 00480-3686-01 dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate 12.5; 12.5; 12.5; 12.5 mg/1; mg/1; mg/1; mg/1 Details

    dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate 12.5; 12.5; 12.5; 12.5 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 Teva Pharmaceuticals, Inc.. The primary component is AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE.

    Product Information

    NDC 00480-3686
    Product ID 0480-3686_474c1435-76cc-4db0-872d-e6c20aea41a9
    Associated GPIs
    GCN Sequence Number 077501
    GCN Sequence Number Description dextroamphetamine/amphetamine CPTP 24HR 50 MG ORAL
    HIC3 J5B
    HIC3 Description ADRENERGICS, AROMATIC, NON-CATECHOLAMINE
    GCN 43543
    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 12.5; 12.5; 12.5; 12.5
    Active Ingredient Units mg/1; mg/1; mg/1; mg/1
    Substance Name AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
    Labeler Name Teva Pharmaceuticals, Inc.
    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 ANDA210876
    Listing Certified Through 2024-12-31

    Package

    NDC 00480-3686-01 (00480368601)

    NDC Package Code 0480-3686-01
    Billing NDC 00480368601
    Package 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0480-3686-01)
    Marketing Start Date 2023-10-10
    NDC Exclude Flag N
    Pricing Information N/A