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    NDC 00143-9280-01 Mitomycin 40 mg/80mL Details

    Mitomycin 40 mg/80mL

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

    Product Information

    NDC 00143-9280
    Product ID 0143-9280_643836ac-d4dc-426c-96fa-44ef273198bc
    Associated GPIs 21200050002120
    GCN Sequence Number 008821
    GCN Sequence Number Description mitomycin VIAL 40 MG INTRAVEN
    HIC3 V1D
    HIC3 Description ANTIBIOTIC ANTINEOPLASTICS
    GCN 38602
    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 40
    Active Ingredient Units mg/80mL
    Substance Name MITOMYCIN
    Labeler Name Hikma Pharmaceuticals USA Inc.
    Pharmaceutical Class Alkylating Activity [MoA], Alkylating Drug [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA064117
    Listing Certified Through 2024-12-31

    Package

    NDC 00143-9280-01 (00143928001)

    NDC Package Code 0143-9280-01
    Billing NDC 00143928001
    Package 1 VIAL in 1 BOX, UNIT-DOSE (0143-9280-01) / 80 mL in 1 VIAL
    Marketing Start Date 1999-09-01
    NDC Exclude Flag N
    Pricing Information N/A