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    NDC 70860-0785-05 Palonosetron Hydrochloride 0.05 mg/mL Details

    Palonosetron Hydrochloride 0.05 mg/mL

    Palonosetron Hydrochloride is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Athenex Pharmaceutical Division, LLC.. The primary component is PALONOSETRON HYDROCHLORIDE.

    Product Information

    NDC 70860-0785
    Product ID 70860-785_e1a9e1d6-12c6-44d5-8cec-b923e0d7e171
    Associated GPIs
    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, SOLUTION
    Route INTRAVENOUS
    Active Ingredient Strength 0.05
    Active Ingredient Units mg/mL
    Substance Name PALONOSETRON HYDROCHLORIDE
    Labeler Name Athenex Pharmaceutical Division, LLC.
    Pharmaceutical Class Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA202951
    Listing Certified Through n/a

    Package

    NDC 70860-0785-05 (70860078505)

    NDC Package Code 70860-785-05
    Billing NDC 70860078505
    Package 1 VIAL, SINGLE-DOSE in 1 CARTON (70860-785-05) / 5 mL in 1 VIAL, SINGLE-DOSE
    Marketing Start Date 2022-10-01
    NDC Exclude Flag N
    Pricing Information N/A