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    NDC 00270-7097-08 LumaSon .19; .19; 60.7 mg/mg; mg/mg; mg/mg Details

    LumaSon .19; .19; 60.7 mg/mg; mg/mg; mg/mg

    LumaSon is a INTRAVENOUS; INTRAVESICAL INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by BRACCO DIAGNOSTICS INC. The primary component is DISTEAROYLPHOSPHATIDYLCHOLINE, DL-; SODIUM 1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHO-(1'-RAC-GLYCEROL); SULFUR HEXAFLUORIDE.

    Product Information

    NDC 00270-7097
    Product ID 0270-7097_f2ac7c1e-74f0-9fb2-d158-5123798b89cc
    Associated GPIs
    GCN Sequence Number 059242
    GCN Sequence Number Description sulfur hexafluoride microsphr VIAL 25 MG INTRAVEN
    HIC3 Z9D
    HIC3 Description DIAGNOSTIC PREPARATIONS,MISCELLANEOUS
    GCN 24815
    HICL Sequence Number 032972
    HICL Sequence Number Description SULFUR HEXAFLUORIDE MICROSPHERES
    Brand/Generic Brand
    Proprietary Name LumaSon
    Proprietary Name Suffix n/a
    Non-Proprietary Name SULFUR HEXAFLUORIDE
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
    Route INTRAVENOUS; INTRAVESICAL
    Active Ingredient Strength .19; .19; 60.7
    Active Ingredient Units mg/mg; mg/mg; mg/mg
    Substance Name DISTEAROYLPHOSPHATIDYLCHOLINE, DL-; SODIUM 1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHO-(1'-RAC-GLYCEROL); SULFUR HEXAFLUORIDE
    Labeler Name BRACCO DIAGNOSTICS INC
    Pharmaceutical Class Contrast Agent for Ultrasound Imaging [EPC], Ultrasound Contrast Activity [MoA]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA203684
    Listing Certified Through 2024-12-31

    Package

    NDC 00270-7097-08 (00270709708)

    NDC Package Code 0270-7097-08
    Billing NDC 00270709708
    Package 20 VIAL in 1 BOX (0270-7097-08) / 25 mg in 1 VIAL
    Marketing Start Date 2021-04-01
    NDC Exclude Flag N
    Pricing Information N/A