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    NDC 68001-0376-68 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 BluePoint Laboratories. The primary component is DAPTOMYCIN.

    Product Information

    NDC 68001-0376
    Product ID 68001-376_fd7800e8-666c-e036-e053-6394a90af158
    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 BluePoint Laboratories
    Pharmaceutical Class Lipopeptide Antibacterial [EPC], Lipopeptides [CS]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA208375
    Listing Certified Through 2024-12-31

    Package

    NDC 68001-0376-68 (68001037668)

    NDC Package Code 68001-376-68
    Billing NDC 68001037668
    Package 1 VIAL, SINGLE-DOSE in 1 CARTON (68001-376-68) / 10 mL in 1 VIAL, SINGLE-DOSE
    Marketing Start Date 2019-05-01
    NDC Exclude Flag N
    Pricing Information N/A