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    NDC 00143-9513-01 Palonosetron Hydrochloride 0.25 mg/2mL Details

    Palonosetron Hydrochloride 0.25 mg/2mL

    Palonosetron Hydrochloride is a INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by West-Ward Pharmaceuticals Corp. The primary component is PALONOSETRON HYDROCHLORIDE.

    Product Information

    NDC 00143-9513
    Product ID 0143-9513_7dc05b1a-344a-410b-a7b3-171727713cf1
    Associated GPIs 50250070102030
    GCN Sequence Number 076512
    GCN Sequence Number Description palonosetron HCl VIAL 0.25MG/2ML INTRAVEN
    HIC3 H6J
    HIC3 Description ANTIEMETIC/ANTIVERTIGO AGENTS
    GCN 42097
    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/2mL
    Substance Name PALONOSETRON HYDROCHLORIDE
    Labeler Name West-Ward Pharmaceuticals Corp
    Pharmaceutical Class Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA207963
    Listing Certified Through 2024-12-31

    Package

    NDC 00143-9513-01 (00143951301)

    NDC Package Code 0143-9513-01
    Billing NDC 00143951301
    Package 2 mL in 1 VIAL (0143-9513-01)
    Marketing Start Date 2017-09-01
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL bb20ba9b-aa8c-4b24-8124-aff0cb6c956b Details

    Revised: 12/2018