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    NDC 00781-9315-70 Oxaliplatin 5 mg/mL Details

    Oxaliplatin 5 mg/mL

    Oxaliplatin is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Sandoz Inc. The primary component is OXALIPLATIN.

    Product Information

    NDC 00781-9315
    Product ID 0781-9315_01167ee3-8eca-428d-a822-7a7e41c40f60
    Associated GPIs 21100028002025
    GCN Sequence Number 059162
    GCN Sequence Number Description oxaliplatin VIAL 50 MG/10ML INTRAVEN
    HIC3 V1A
    HIC3 Description ANTINEOPLASTIC - ALKYLATING AGENTS
    GCN 24699
    HICL Sequence Number 016687
    HICL Sequence Number Description OXALIPLATIN
    Brand/Generic Generic
    Proprietary Name Oxaliplatin
    Proprietary Name Suffix n/a
    Non-Proprietary Name Oxaliplatin
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION, SOLUTION
    Route INTRAVENOUS
    Active Ingredient Strength 5
    Active Ingredient Units mg/mL
    Substance Name OXALIPLATIN
    Labeler Name Sandoz Inc
    Pharmaceutical Class Platinum-based Drug [EPC], Platinum-containing Compounds [EXT]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA078817
    Listing Certified Through 2024-12-31

    Package

    NDC 00781-9315-70 (00781931570)

    NDC Package Code 0781-9315-70
    Billing NDC 00781931570
    Package 1 VIAL, SINGLE-USE in 1 CARTON (0781-9315-70) / 10 mL in 1 VIAL, SINGLE-USE
    Marketing Start Date 2016-07-01
    NDC Exclude Flag N
    Pricing Information N/A