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    NDC 63629-4023-07 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 Bryant Ranch Prepack. The primary component is ONDANSETRON HYDROCHLORIDE.

    Product Information

    NDC 63629-4023
    Product ID 63629-4023_d9d5dd5d-6101-46bf-ac11-b105f625c78c
    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 Bryant Ranch Prepack
    Pharmaceutical Class Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA077050
    Listing Certified Through 2023-12-31

    Package

    NDC 63629-4023-07 (63629402307)

    NDC Package Code 63629-4023-7
    Billing NDC 63629402307
    Package 90 TABLET, FILM COATED in 1 BOTTLE (63629-4023-7)
    Marketing Start Date 2013-04-12
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL d9d5dd5d-6101-46bf-ac11-b105f625c78c Details

    Revised: 2/2022