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    NDC 55150-0393-01 AZACITIDINE 100 mg/4mL Details

    AZACITIDINE 100 mg/4mL

    AZACITIDINE is a INTRAVENOUS; SUBCUTANEOUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Eugia US LLC. The primary component is AZACITIDINE.

    Product Information

    NDC 55150-0393
    Product ID 55150-393_23509cbb-fa31-4369-98d1-2ce454828db9
    Associated GPIs
    GCN Sequence Number 054660
    GCN Sequence Number Description azacitidine VIAL 100 MG INJECTION
    HIC3 V1B
    HIC3 Description ANTINEOPLASTIC - ANTIMETABOLITES
    GCN 22663
    HICL Sequence Number 026361
    HICL Sequence Number Description AZACITIDINE
    Brand/Generic Generic
    Proprietary Name AZACITIDINE
    Proprietary Name Suffix n/a
    Non-Proprietary Name AZACITIDINE
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
    Route INTRAVENOUS; SUBCUTANEOUS
    Active Ingredient Strength 100
    Active Ingredient Units mg/4mL
    Substance Name AZACITIDINE
    Labeler Name Eugia US LLC
    Pharmaceutical Class Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA215066
    Listing Certified Through 2024-12-31

    Package

    NDC 55150-0393-01 (55150039301)

    NDC Package Code 55150-393-01
    Billing NDC 55150039301
    Package 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-393-01) / 4 mL in 1 VIAL, SINGLE-DOSE
    Marketing Start Date 2023-01-03
    NDC Exclude Flag N
    Pricing Information N/A