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    NDC 36000-0326-02 Palonosetron Hydrochloride 0.25 mg/5mL Details

    Palonosetron Hydrochloride 0.25 mg/5mL

    Palonosetron Hydrochloride is a INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Baxter Healthcare Corporation. The primary component is PALONOSETRON HYDROCHLORIDE.

    Product Information

    NDC 36000-0326
    Product ID 36000-326_0250c21a-fa1f-4f35-98a4-9620ada5231a
    Associated GPIs 50250070102020
    GCN Sequence Number 052943
    GCN Sequence Number Description palonosetron HCl VIAL 0.25MG/5ML INTRAVEN
    HIC3 H6J
    HIC3 Description ANTIEMETIC/ANTIVERTIGO AGENTS
    GCN 20228
    HICL Sequence Number 025512
    HICL Sequence Number Description PALONOSETRON HCL
    Brand/Generic Generic
    Proprietary Name Palonosetron Hydrochloride
    Proprietary Name Suffix n/a
    Non-Proprietary Name palonosetron hydrochloride
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION
    Route INTRAVENOUS
    Active Ingredient Strength 0.25
    Active Ingredient Units mg/5mL
    Substance Name PALONOSETRON HYDROCHLORIDE
    Labeler Name Baxter Healthcare Corporation
    Pharmaceutical Class Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA206916
    Listing Certified Through 2024-12-31

    Package

    NDC 36000-0326-02 (36000032602)

    NDC Package Code 36000-326-02
    Billing NDC 36000032602
    Package 1 VIAL in 1 CARTON (36000-326-02) / 5 mL in 1 VIAL (36000-326-01)
    Marketing Start Date 2021-11-12
    NDC Exclude Flag N
    Pricing Information N/A