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    NDC 63629-8527-01 Paroxetine Hydrochloride 25 mg/1 Details

    Paroxetine Hydrochloride 25 mg/1

    Paroxetine Hydrochloride is a ORAL TABLET, FILM COATED, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is PAROXETINE HYDROCHLORIDE HEMIHYDRATE.

    Product Information

    NDC 63629-8527
    Product ID 63629-8527_d72b03fa-f81e-4eab-95aa-00c6c48ebf37
    Associated GPIs 58160060007530
    GCN Sequence Number 050136
    GCN Sequence Number Description paroxetine HCl TAB ER 24H 25 MG ORAL
    HIC3 H2S
    HIC3 Description SELECTIVE SEROTONIN REUPTAKE INHIBITOR (SSRIS)
    GCN 17077
    HICL Sequence Number 007344
    HICL Sequence Number Description PAROXETINE HCL
    Brand/Generic Generic
    Proprietary Name Paroxetine Hydrochloride
    Proprietary Name Suffix n/a
    Non-Proprietary Name Paroxetine Hydrochloride
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
    Route ORAL
    Active Ingredient Strength 25
    Active Ingredient Units mg/1
    Substance Name PAROXETINE HYDROCHLORIDE HEMIHYDRATE
    Labeler Name Bryant Ranch Prepack
    Pharmaceutical Class Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA204744
    Listing Certified Through 2025-12-31

    Package

    NDC 63629-8527-01 (63629852701)

    NDC Package Code 63629-8527-1
    Billing NDC 63629852701
    Package 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-8527-1)
    Marketing Start Date 2014-10-31
    NDC Exclude Flag N
    Pricing Information N/A