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    NDC 00115-5445-13 Bupropion Hydrochloride 200 mg/1 Details

    Bupropion Hydrochloride 200 mg/1

    Bupropion Hydrochloride is a ORAL TABLET, FILM COATED, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amneal Pharmaceuticals of New York LLC. The primary component is BUPROPION HYDROCHLORIDE.

    Product Information

    NDC 00115-5445
    Product ID 0115-5445_5fed6a81-828f-4e98-b001-a379b7551fb7
    Associated GPIs 58300040107440
    GCN Sequence Number 050496
    GCN Sequence Number Description bupropion HCl TAB SR 12H 200 MG ORAL
    HIC3 H7D
    HIC3 Description NOREPINEPHRINE AND DOPAMINE REUPTAKE INHIB (NDRIS)
    GCN 17573
    HICL Sequence Number 001653
    HICL Sequence Number Description BUPROPION HCL
    Brand/Generic Generic
    Proprietary Name Bupropion Hydrochloride
    Proprietary Name Suffix n/a
    Non-Proprietary Name BUPROPION HYDROCHLORIDE
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
    Route ORAL
    Active Ingredient Strength 200
    Active Ingredient Units mg/1
    Substance Name BUPROPION HYDROCHLORIDE
    Labeler Name Amneal Pharmaceuticals of New York LLC
    Pharmaceutical Class Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA076711
    Listing Certified Through 2024-12-31

    Package

    NDC 00115-5445-13 (00115544513)

    NDC Package Code 0115-5445-13
    Billing NDC 00115544513
    Package 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-5445-13)
    Marketing Start Date 2004-12-03
    NDC Exclude Flag N
    Pricing Information N/A