LumaSon
These highlights do not include all the information needed to use LUMASON safely and effectively. See full prescribing information for LUMASON. LUMASON (sulfur hexafluoride lipid-type A microspheres) for injectable suspension, for intravenous use or intravesical useInitial U.S. Approval: 2014
Approved
Approval ID
7c679424-c3f7-ed02-892f-20ca0d775089
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 10, 2023
Manufacturers
FDA
BRACCO DIAGNOSTICS INC
DUNS: 849234661
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
SULFUR HEXAFLUORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0270-7099
Application NumberNDA203684
Product Classification
M
Marketing Category
C73594
G
Generic Name
SULFUR HEXAFLUORIDE
Product Specifications
Effective DateJanuary 10, 2021
FDA Product Classification
SULFUR HEXAFLUORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0270-7097
Application NumberNDA203684
Product Classification
M
Marketing Category
C73594
G
Generic Name
SULFUR HEXAFLUORIDE
Product Specifications
Route of AdministrationINTRAVESICAL, INTRAVENOUS
Effective DateJanuary 10, 2021
FDA Product Classification
INGREDIENTS (5)
SULFUR HEXAFLUORIDEActive
Quantity: 60.7 mg in 1 mg
Code: WS7LR3I1D6
Classification: ACTIB
POLYETHYLENE GLYCOL 4000Inactive
Quantity: 24.56 mg in 1 mg
Code: 4R4HFI6D95
Classification: IACT
SODIUM 1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHO-(1'-RAC-GLYCEROL)Active
Quantity: .19 mg in 1 mg
Code: 841B886EJ7
Classification: ACTIB
DISTEAROYLPHOSPHATIDYLCHOLINE, DL-Active
Quantity: .19 mg in 1 mg
Code: EAG959U971
Classification: ACTIB
PALMITIC ACIDInactive
Quantity: .04 mg in 1 mg
Code: 2V16EO95H1
Classification: IACT