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    NDC 70954-0319-10 Paroxetine 10 mg/5mL Details

    Paroxetine 10 mg/5mL

    Paroxetine is a ORAL SUSPENSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by ANI Pharmaceuticals, Inc.. The primary component is PAROXETINE HYDROCHLORIDE HEMIHYDRATE.

    Product Information

    NDC 70954-0319
    Product ID 70954-319_02316e52-539c-488e-888e-a12f541cb075
    Associated GPIs 58160060001820
    GCN Sequence Number 046226
    GCN Sequence Number Description paroxetine HCl ORAL SUSP 10 MG/5 ML ORAL
    HIC3 H2S
    HIC3 Description SELECTIVE SEROTONIN REUPTAKE INHIBITOR (SSRIS)
    GCN 16369
    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
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form SUSPENSION
    Route ORAL
    Active Ingredient Strength 10
    Active Ingredient Units mg/5mL
    Substance Name PAROXETINE HYDROCHLORIDE HEMIHYDRATE
    Labeler Name ANI Pharmaceuticals, Inc.
    Pharmaceutical Class Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA215003
    Listing Certified Through 2024-12-31

    Package

    NDC 70954-0319-10 (70954031910)

    NDC Package Code 70954-319-10
    Billing NDC 70954031910
    Package 250 mL in 1 BOTTLE (70954-319-10)
    Marketing Start Date 2021-09-03
    NDC Exclude Flag N
    Pricing Information N/A