NDC 0270-7097 Lumason

Sulfur Hexafluoride Injection, Powder, Lyophilized, For Suspension Intravenous; - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0270-7097
Proprietary Name:
Lumason
Non-Proprietary Name: [1]
Sulfur Hexafluoride
Substance Name: [2]
Distearoylphosphatidylcholine, Dl-; Sodium 1,2-dipalmitoyl-sn-glycero-3-phospho-(1'-rac-glycerol); Sulfur Hexafluoride
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Injection, Powder, Lyophilized, For Suspension - A liquid preparation, intended for parenteral use that contains solids suspended in a suitable fluid medium and conforms in all respects to the requirements for Sterile Suspensions; the medicinal agents intended for the suspension are prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures.
Administration Route(s): [4]
  • Intravenous - Administration within or into a vein or veins.
  • Intravesical - Administration within the bladder.
  • Intravenous - Administration within or into a vein or veins.
  • Intravesical - Administration within the bladder.
  • Labeler Name: [5]
    Bracco Diagnostics Inc
    Labeler Code:
    0270
    FDA Application Number: [6]
    NDA203684
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    04-01-2021
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 0270-7097-07

    Package Description: 20 VIAL in 1 BOX / 25 mg in 1 VIAL

    NDC Code 0270-7097-08

    Package Description: 20 VIAL in 1 BOX / 25 mg in 1 VIAL

    Product Details

    What is NDC 0270-7097?

    The NDC code 0270-7097 is assigned by the FDA to the product Lumason which is a human prescription drug product labeled by Bracco Diagnostics Inc. The generic name of Lumason is sulfur hexafluoride. The product's dosage form is injection, powder, lyophilized, for suspension and is administered via intravenous; intravesical form. The product is distributed in 2 packages with assigned NDC codes 0270-7097-07 20 vial in 1 box / 25 mg in 1 vial, 0270-7097-08 20 vial in 1 box / 25 mg in 1 vial. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Lumason?

    EchocardiographyLumason is indicated for use in adult and pediatric patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.Ultrasonography of the LiverLumason is indicated for use with ultrasound of the liver in adult and pediatric patients to characterize focal liver lesions.Ultrasonography of the Urinary TractLumason is indicated for use in ultrasonography of the urinary tract in pediatric patients for the evaluation of suspected or known vesicoureteral reflux.

    What are Lumason Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    Which are the Pharmacologic Classes for Lumason?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

    [8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

    [12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".