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    NDC 00407-2707-18 Optison 10; .22 mg/mL; mg/mL Details

    Optison 10; .22 mg/mL; mg/mL

    Optison is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by GE Healthcare Inc.. The primary component is HUMAN ALBUMIN MICROSPHERES; PERFLUTREN.

    Product Information

    NDC 00407-2707
    Product ID 0407-2707_63524386-08e9-49e4-aafd-91057f33ebf4
    Associated GPIs 94500075401820
    GCN Sequence Number 064507
    GCN Sequence Number Description perflutren protein-A microsphr VIAL 0.22MG/ML INTRAVEN
    HIC3 A6V
    HIC3 Description CARDIOVASCULAR DIAGNOSTICS,NON-RADIOPAQUE AGENTS
    GCN 14454
    HICL Sequence Number 021754
    HICL Sequence Number Description PERFLUTREN PROTEIN-A MICROSPHR
    Brand/Generic Brand
    Proprietary Name Optison
    Proprietary Name Suffix Perflutren Protein-Type A Microspheres
    Non-Proprietary Name Human Albumin Microspheres and Perflutren
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION, SOLUTION
    Route INTRAVENOUS
    Active Ingredient Strength 10; .22
    Active Ingredient Units mg/mL; mg/mL
    Substance Name HUMAN ALBUMIN MICROSPHERES; PERFLUTREN
    Labeler Name GE Healthcare Inc.
    Pharmaceutical Class Contrast Agent for Ultrasound Imaging [EPC], Contrast Agent for Ultrasound Imaging [EPC], Ultrasound Contrast Activity [MoA], Ultrasound Contrast Activity [MoA]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA020899
    Listing Certified Through 2025-12-31

    Package

    NDC 00407-2707-18 (00407270718)

    NDC Package Code 0407-2707-18
    Billing NDC 00407270718
    Package 18 VIAL, SINGLE-USE in 1 CARTON (0407-2707-18) / 3 mL in 1 VIAL, SINGLE-USE
    Marketing Start Date 2002-01-02
    NDC Exclude Flag N
    Pricing Information N/A