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    NDC 70594-0066-01 Daptomycin 350 mg/7mL Details

    Daptomycin 350 mg/7mL

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

    Product Information

    NDC 70594-0066
    Product ID 70594-066_77b4504d-ddb3-40eb-9885-5c7c46a36dad
    Associated GPIs
    GCN Sequence Number 060477
    GCN Sequence Number Description daptomycin VIAL 350 MG INTRAVEN
    HIC3 W9B
    HIC3 Description CYCLIC LIPOPEPTIDES
    GCN 26638
    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 350
    Active Ingredient Units mg/7mL
    Substance Name DAPTOMYCIN
    Labeler Name Xellia Pharmaceuticals USA LLC
    Pharmaceutical Class Lipopeptide Antibacterial [EPC], Lipopeptides [CS]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA217415
    Listing Certified Through 2024-12-31

    Package

    NDC 70594-0066-01 (70594006601)

    NDC Package Code 70594-066-01
    Billing NDC 70594006601
    Package 1 VIAL, SINGLE-USE in 1 CARTON (70594-066-01) / 7 mL in 1 VIAL, SINGLE-USE
    Marketing Start Date 2023-11-03
    NDC Exclude Flag N
    Pricing Information N/A