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    NDC 00078-0690-61 ARZERRA 20 mg/mL Details

    ARZERRA 20 mg/mL

    ARZERRA is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is OFATUMUMAB.

    Product Information

    NDC 00078-0690
    Product ID 0078-0690_1358cb68-5521-4de1-9749-5ed66f293d3b
    Associated GPIs 21351845001360
    GCN Sequence Number 067553
    GCN Sequence Number Description ofatumumab VIAL 1000 MG/50 INTRAVEN
    HIC3 Z2W
    HIC3 Description ANTI-CD20 (B LYMPHOCYTE) MONOCLONAL ANTIBODY
    GCN 30137
    HICL Sequence Number 036708
    HICL Sequence Number Description OFATUMUMAB
    Brand/Generic Brand
    Proprietary Name ARZERRA
    Proprietary Name Suffix n/a
    Non-Proprietary Name ofatumumab
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION, SOLUTION
    Route INTRAVENOUS
    Active Ingredient Strength 20
    Active Ingredient Units mg/mL
    Substance Name OFATUMUMAB
    Labeler Name Novartis Pharmaceuticals Corporation
    Pharmaceutical Class CD20-directed Antibody Interactions [MoA], CD20-directed Cytolytic Antibody [EPC]
    DEA Schedule n/a
    Marketing Category BLA
    Application Number BLA125326
    Listing Certified Through 2024-12-31

    Package

    NDC 00078-0690-61 (00078069061)

    NDC Package Code 0078-0690-61
    Billing NDC 00078069061
    Package 50 mL in 1 VIAL, SINGLE-USE (0078-0690-61)
    Marketing Start Date 2016-02-01
    NDC Exclude Flag N
    Pricing Information N/A