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    NDC 25021-0250-20 Mitomycin 5 mg/10mL Details

    Mitomycin 5 mg/10mL

    Mitomycin is a INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Sagent Pharmaceuticals. The primary component is MITOMYCIN.

    Product Information

    NDC 25021-0250
    Product ID 25021-250_865914d0-b74e-4beb-a7d1-e31a82b75c05
    Associated GPIs
    GCN Sequence Number 008822
    GCN Sequence Number Description mitomycin VIAL 5 MG INTRAVEN
    HIC3 V1D
    HIC3 Description ANTIBIOTIC ANTINEOPLASTICS
    GCN 38601
    HICL Sequence Number 003917
    HICL Sequence Number Description MITOMYCIN
    Brand/Generic Generic
    Proprietary Name Mitomycin
    Proprietary Name Suffix n/a
    Non-Proprietary Name Mitomycin
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
    Route INTRAVENOUS
    Active Ingredient Strength 5
    Active Ingredient Units mg/10mL
    Substance Name MITOMYCIN
    Labeler Name Sagent Pharmaceuticals
    Pharmaceutical Class Alkylating Activity [MoA], Alkylating Drug [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA215687
    Listing Certified Through 2024-12-31

    Package

    NDC 25021-0250-20 (25021025020)

    NDC Package Code 25021-250-20
    Billing NDC 25021025020
    Package 1 VIAL in 1 CARTON (25021-250-20) / 10 mL in 1 VIAL
    Marketing Start Date 2023-06-15
    NDC Exclude Flag N
    Pricing Information N/A