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    NDC 63323-0374-20 Ondansetron 2 mg/mL Details

    Ondansetron 2 mg/mL

    Ondansetron is a INTRAMUSCULAR; INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Fresenius Kabi USA, LLC. The primary component is ONDANSETRON HYDROCHLORIDE.

    Product Information

    NDC 63323-0374
    Product ID 63323-374_83824969-e116-40d6-8940-ff134a4f16c0
    Associated GPIs 50250065052030
    GCN Sequence Number 015869
    GCN Sequence Number Description ondansetron HCl VIAL 2 MG/ML INTRAVEN
    HIC3 H6J
    HIC3 Description ANTIEMETIC/ANTIVERTIGO AGENTS
    GCN 20011
    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 INJECTION
    Route INTRAMUSCULAR; INTRAVENOUS
    Active Ingredient Strength 2
    Active Ingredient Units mg/mL
    Substance Name ONDANSETRON HYDROCHLORIDE
    Labeler Name Fresenius Kabi USA, LLC
    Pharmaceutical Class Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA076974
    Listing Certified Through 2024-12-31

    Package

    NDC 63323-0374-20 (63323037420)

    NDC Package Code 63323-374-20
    Billing NDC 63323037420
    Package 1 VIAL in 1 BOX (63323-374-20) / 20 mL in 1 VIAL
    Marketing Start Date 2009-11-18
    NDC Exclude Flag N
    Pricing Information N/A