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
NDC Product Code0270-7099
Application NumberNDA203684
Marketing CategoryC73594
Route of AdministrationN/A
Effective DateJanuary 10, 2021
Generic NameSULFUR HEXAFLUORIDE
SULFUR HEXAFLUORIDE
PRODUCT DETAILS
NDC Product Code0270-7097
Application NumberNDA203684
Marketing CategoryC73594
Route of AdministrationINTRAVESICAL, INTRAVENOUS
Effective DateJanuary 10, 2021
Generic NameSULFUR HEXAFLUORIDE
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