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    NDC 68180-0645-01 PAROXETINE 37.5 mg/1 Details

    PAROXETINE 37.5 mg/1

    PAROXETINE is a ORAL TABLET, FILM COATED, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Lupin Pharmaceuticals, Inc.. The primary component is PAROXETINE HYDROCHLORIDE HEMIHYDRATE.

    Product Information

    NDC 68180-0645
    Product ID 68180-645_1a9bc25c-db83-42a0-851a-30212ee10cc6
    Associated GPIs 58160060007540
    GCN Sequence Number 050138
    GCN Sequence Number Description paroxetine HCl TAB ER 24H 37.5 MG ORAL
    HIC3 H2S
    HIC3 Description SELECTIVE SEROTONIN REUPTAKE INHIBITOR (SSRIS)
    GCN 17079
    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 TABLET, FILM COATED, EXTENDED RELEASE
    Route ORAL
    Active Ingredient Strength 37.5
    Active Ingredient Units mg/1
    Substance Name PAROXETINE HYDROCHLORIDE HEMIHYDRATE
    Labeler Name Lupin Pharmaceuticals, Inc.
    Pharmaceutical Class Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA204134
    Listing Certified Through 2024-12-31

    Package

    NDC 68180-0645-01 (68180064501)

    NDC Package Code 68180-645-01
    Billing NDC 68180064501
    Package 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68180-645-01)
    Marketing Start Date 2017-03-06
    NDC Exclude Flag N
    Pricing Information N/A