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    NDC 60505-6229-04 Daptomycin 500 mg/10mL Details

    Daptomycin 500 mg/10mL

    Daptomycin is a INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by APOTEX CORP.. The primary component is DAPTOMYCIN.

    Product Information

    NDC 60505-6229
    Product ID 60505-6229_0d64e4bc-6ac6-3e05-e063-6294a90aaa71
    Associated GPIs 16270030002140
    GCN Sequence Number 053190
    GCN Sequence Number Description daptomycin VIAL 500 MG INTRAVEN
    HIC3 W9B
    HIC3 Description CYCLIC LIPOPEPTIDES
    GCN 20569
    HICL Sequence Number 025673
    HICL Sequence Number Description DAPTOMYCIN
    Brand/Generic Generic
    Proprietary Name Daptomycin
    Proprietary Name Suffix n/a
    Non-Proprietary Name Daptomycin
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
    Route INTRAVENOUS
    Active Ingredient Strength 500
    Active Ingredient Units mg/10mL
    Substance Name DAPTOMYCIN
    Labeler Name APOTEX CORP.
    Pharmaceutical Class Lipopeptide Antibacterial [EPC], Lipopeptides [CS]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA215316
    Listing Certified Through 2024-12-31

    Package

    NDC 60505-6229-04 (60505622904)

    NDC Package Code 60505-6229-4
    Billing NDC 60505622904
    Package 1 VIAL, SINGLE-USE in 1 CARTON (60505-6229-4) / 10 mL in 1 VIAL, SINGLE-USE
    Marketing Start Date 2022-02-23
    NDC Exclude Flag N
    Pricing Information N/A