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    NDC 65862-0154-01 Paroxetine 10 mg/1 Details

    Paroxetine 10 mg/1

    Paroxetine is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Aurobindo Pharma Limited. The primary component is PAROXETINE HYDROCHLORIDE HEMIHYDRATE.

    Product Information

    NDC 65862-0154
    Product ID 65862-154_905f7b97-d2fb-4414-a571-1629a86d52e9
    Associated GPIs
    GCN Sequence Number 046222
    GCN Sequence Number Description paroxetine HCl TABLET 10 MG ORAL
    HIC3 H2S
    HIC3 Description SELECTIVE SEROTONIN REUPTAKE INHIBITOR (SSRIS)
    GCN 16364
    HICL Sequence Number 007344
    HICL Sequence Number Description PAROXETINE HCL
    Brand/Generic Generic
    Proprietary Name Paroxetine
    Proprietary Name Suffix n/a
    Non-Proprietary Name Paroxetine Hydrochloride
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 10
    Active Ingredient Units mg/1
    Substance Name PAROXETINE HYDROCHLORIDE HEMIHYDRATE
    Labeler Name Aurobindo Pharma Limited
    Pharmaceutical Class Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA078406
    Listing Certified Through 2024-12-31

    Package

    NDC 65862-0154-01 (65862015401)

    NDC Package Code 65862-154-01
    Billing NDC 65862015401
    Package 100 TABLET, FILM COATED in 1 BOTTLE (65862-154-01)
    Marketing Start Date 2007-07-25
    NDC Exclude Flag N
    Pricing Information N/A