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    NDC 65862-0187-99 Ondansetron Hydrochloride 4 mg/1 Details

    Ondansetron Hydrochloride 4 mg/1

    Ondansetron Hydrochloride 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 ONDANSETRON HYDROCHLORIDE.

    Product Information

    NDC 65862-0187
    Product ID 65862-187_23292a95-b91b-426f-aeb9-bfea73f156f2
    Associated GPIs 50250065050310
    GCN Sequence Number 016392
    GCN Sequence Number Description ondansetron HCl TABLET 4 MG ORAL
    HIC3 H6J
    HIC3 Description ANTIEMETIC/ANTIVERTIGO AGENTS
    GCN 20041
    HICL Sequence Number 006055
    HICL Sequence Number Description ONDANSETRON HCL
    Brand/Generic Generic
    Proprietary Name Ondansetron Hydrochloride
    Proprietary Name Suffix n/a
    Non-Proprietary Name Ondansetron Hydrochloride
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 4
    Active Ingredient Units mg/1
    Substance Name ONDANSETRON HYDROCHLORIDE
    Labeler Name Aurobindo Pharma Limited
    Pharmaceutical Class Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA078539
    Listing Certified Through 2024-12-31

    Package

    NDC 65862-0187-99 (65862018799)

    NDC Package Code 65862-187-99
    Billing NDC 65862018799
    Package 1000 TABLET, FILM COATED in 1 BOTTLE (65862-187-99)
    Marketing Start Date 2007-07-31
    NDC Exclude Flag N
    Pricing Information N/A