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    NDC 55700-0627-20 Ondansetron Hydrochloride 8 mg/1 Details

    Ondansetron Hydrochloride 8 mg/1

    Ondansetron Hydrochloride is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Quality Care Products LLC. The primary component is ONDANSETRON HYDROCHLORIDE.

    Product Information

    NDC 55700-0627
    Product ID 55700-627_42375fc5-e0f8-4aef-acce-d1374118e800
    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 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 8
    Active Ingredient Units mg/1
    Substance Name ONDANSETRON HYDROCHLORIDE
    Labeler Name Quality Care Products LLC
    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 55700-0627-20 (55700062720)

    NDC Package Code 55700-627-20
    Billing NDC 55700062720
    Package 20 TABLET, FILM COATED in 1 BOTTLE (55700-627-20)
    Marketing Start Date 2018-05-18
    NDC Exclude Flag N
    Pricing Information N/A