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    NDC 43063-0770-06 Ondansetron 8 mg/1 Details

    Ondansetron 8 mg/1

    Ondansetron 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 ONDANSETRON HYDROCHLORIDE.

    Product Information

    NDC 43063-0770
    Product ID 43063-770_065a1b49-0374-2df7-e063-6394a90a5870
    Associated GPIs 50250065050320
    GCN Sequence Number 016393
    GCN Sequence Number Description ondansetron HCl TABLET 8 MG ORAL
    HIC3 H6J
    HIC3 Description ANTIEMETIC/ANTIVERTIGO AGENTS
    GCN 20042
    HICL Sequence Number 006055
    HICL Sequence Number Description ONDANSETRON HCL
    Brand/Generic Generic
    Proprietary Name Ondansetron
    Proprietary Name Suffix n/a
    Non-Proprietary Name Ondansetron
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 8
    Active Ingredient Units mg/1
    Substance Name ONDANSETRON HYDROCHLORIDE
    Labeler Name PD-Rx Pharmaceuticals, Inc.
    Pharmaceutical Class Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA077535
    Listing Certified Through 2024-12-31

    Package

    NDC 43063-0770-06 (43063077006)

    NDC Package Code 43063-770-06
    Billing NDC 43063077006
    Package 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-770-06)
    Marketing Start Date 2014-03-03
    NDC Exclude Flag N
    Pricing Information N/A