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    NDC 43063-0746-12 ondansetron 4 mg/1 Details

    ondansetron 4 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 43063-0746
    Product ID 43063-746_0658cf65-3934-06ac-e063-6394a90a2bb4
    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
    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 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 ANDA077851
    Listing Certified Through 2024-12-31

    Package

    NDC 43063-0746-12 (43063074612)

    NDC Package Code 43063-746-12
    Billing NDC 43063074612
    Package 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-746-12)
    Marketing Start Date 2017-02-17
    NDC Exclude Flag N
    Pricing Information N/A