Search by Drug Name or NDC

    NDC 16729-0224-05 Decitabine 50 mg/20mL Details

    Decitabine 50 mg/20mL

    Decitabine is a INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Accord Healthcare Inc.. The primary component is DECITABINE.

    Product Information

    NDC 16729-0224
    Product ID 16729-224_df80c0a9-9560-8219-e053-2995a90ad683
    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 Generic
    Proprietary Name Decitabine
    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 Accord Healthcare Inc.
    Pharmaceutical Class Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA203475
    Listing Certified Through 2024-12-31

    Package

    NDC 16729-0224-05 (16729022405)

    NDC Package Code 16729-224-05
    Billing NDC 16729022405
    Package 1 VIAL in 1 CARTON (16729-224-05) / 20 mL in 1 VIAL
    Marketing Start Date 2017-03-08
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL b46df7d7-d98e-4c7e-b1ee-e03e258781c4 Details

    Revised: 5/2022