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    NDC 71288-0101-20 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 Meitheal Pharmaceuticals Inc.. The primary component is OXALIPLATIN.

    Product Information

    NDC 71288-0101
    Product ID 71288-101_e40ef463-a621-42ca-98fa-4a00c2779695
    Associated GPIs 21100028002025 21100028002030
    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 Meitheal Pharmaceuticals Inc.
    Pharmaceutical Class Platinum-based Drug [EPC], Platinum-containing Compounds [EXT]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA207325
    Listing Certified Through 2025-12-31

    Package

    NDC 71288-0101-20 (71288010120)

    NDC Package Code 71288-101-20
    Billing NDC 71288010120
    Package 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-101-20) / 20 mL in 1 VIAL, SINGLE-DOSE
    Marketing Start Date 2017-10-01
    NDC Exclude Flag N
    Pricing Information N/A