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    NDC 00955-1731-10 OXALIPLATIN 5 mg/mL Details

    OXALIPLATIN 5 mg/mL

    OXALIPLATIN is a INTRAVENOUS INJECTION, SOLUTION, CONCENTRATE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Winthrop U.S, a business of sanofi-aventis U.S. LLC. The primary component is OXALIPLATIN.

    Product Information

    NDC 00955-1731
    Product ID 0955-1731_0bef8406-8dab-0ad0-e063-6394a90a60d0
    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, CONCENTRATE
    Route INTRAVENOUS
    Active Ingredient Strength 5
    Active Ingredient Units mg/mL
    Substance Name OXALIPLATIN
    Labeler Name Winthrop U.S, a business of sanofi-aventis U.S. LLC
    Pharmaceutical Class Platinum-based Drug [EPC], Platinum-containing Compounds [EXT]
    DEA Schedule n/a
    Marketing Category NDA AUTHORIZED GENERIC
    Application Number NDA021759
    Listing Certified Through 2024-12-31

    Package

    NDC 00955-1731-10 (00955173110)

    NDC Package Code 0955-1731-10
    Billing NDC 00955173110
    Package 1 VIAL, GLASS in 1 CARTON (0955-1731-10) / 10 mL in 1 VIAL, GLASS
    Marketing Start Date 2015-09-01
    NDC Exclude Flag N
    Pricing Information N/A