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    NDC 59148-0046-70 Dacogen 50 mg/20mL Details

    Dacogen 50 mg/20mL

    Dacogen is a INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Otsuka America Pharmaceutical, Inc.. The primary component is DECITABINE.

    Product Information

    NDC 59148-0046
    Product ID 59148-046_cb51f321-5384-4486-bcc5-8d86550cae3e
    Associated GPIs 21300015002120
    GCN Sequence Number 060839
    GCN Sequence Number Description decitabine VIAL 50 MG INTRAVEN
    HIC3 V1B
    HIC3 Description ANTINEOPLASTIC - ANTIMETABOLITES
    GCN 27027
    HICL Sequence Number 033712
    HICL Sequence Number Description DECITABINE
    Brand/Generic Brand
    Proprietary Name Dacogen
    Proprietary Name Suffix n/a
    Non-Proprietary Name decitabine
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
    Route INTRAVENOUS
    Active Ingredient Strength 50
    Active Ingredient Units mg/20mL
    Substance Name DECITABINE
    Labeler Name Otsuka America Pharmaceutical, Inc.
    Pharmaceutical Class Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA021790
    Listing Certified Through n/a

    Package

    NDC 59148-0046-70 (59148004670)

    NDC Package Code 59148-046-70
    Billing NDC 59148004670
    Package 1 VIAL in 1 CARTON (59148-046-70) / 20 mL in 1 VIAL
    Marketing Start Date 2006-05-02
    NDC Exclude Flag N
    Pricing Information N/A