Search by Drug Name or NDC

    NDC 55289-0053-45 Paroxetine 40 mg/1 Details

    Paroxetine 40 mg/1

    Paroxetine is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by PD-Rx Pharmaceuticals, Inc.. The primary component is PAROXETINE HYDROCHLORIDE HEMIHYDRATE.

    Product Information

    NDC 55289-0053
    Product ID 55289-053_01526f56-261d-ec88-e063-6394a90ac7c9
    Associated GPIs 58160060000340
    GCN Sequence Number 046225
    GCN Sequence Number Description paroxetine HCl TABLET 40 MG ORAL
    HIC3 H2S
    HIC3 Description SELECTIVE SEROTONIN REUPTAKE INHIBITOR (SSRIS)
    GCN 16368
    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 hemihydrate
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 40
    Active Ingredient Units mg/1
    Substance Name PAROXETINE HYDROCHLORIDE HEMIHYDRATE
    Labeler Name PD-Rx Pharmaceuticals, Inc.
    Pharmaceutical Class Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA078902
    Listing Certified Through 2024-12-31

    Package

    NDC 55289-0053-45 (55289005345)

    NDC Package Code 55289-053-45
    Billing NDC 55289005345
    Package 45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-053-45)
    Marketing Start Date 2010-04-01
    NDC Exclude Flag N
    Pricing Information N/A