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    NDC 00378-0315-93 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 Mylan Pharmaceuticals Inc.. The primary component is ONDANSETRON HYDROCHLORIDE.

    Product Information

    NDC 00378-0315
    Product ID 0378-0315_f80f6db7-f367-4a60-8347-cbb96adb5f34
    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
    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 Mylan Pharmaceuticals Inc.
    Pharmaceutical Class Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA076930
    Listing Certified Through 2023-12-31

    Package

    NDC 00378-0315-93 (00378031593)

    NDC Package Code 0378-0315-93
    Billing NDC 00378031593
    Package 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0315-93)
    Marketing Start Date 2007-06-25
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL a8e652d8-f4ad-4a55-857b-6ec70a71c07b Details

    Revised: 11/2022