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    NDC 72819-0152-05 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 Archis Pharma LLC. The primary component is MITOMYCIN.

    Product Information

    NDC 72819-0152
    Product ID 72819-152_fd60f15a-95d0-b4ae-e053-6394a90a355c
    Associated GPIs 21200050002105
    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 Archis Pharma LLC
    Pharmaceutical Class Alkylating Activity [MoA], Alkylating Drug [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA202670
    Listing Certified Through 2024-12-31

    Package

    NDC 72819-0152-05 (72819015205)

    NDC Package Code 72819-152-05
    Billing NDC 72819015205
    Package 1 VIAL in 1 CARTON (72819-152-05) / 10 mL in 1 VIAL
    Marketing Start Date 2022-04-25
    NDC Exclude Flag N
    Pricing Information N/A