FDA.reportPublic FDA data

Lumason

Product NDC
0270-7097
11-digit product format
002707097
Labeler code
0270
Product ID
0270-7097_47b0f2df-0b6c-a221-750d-763d5ece665b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SULFUR HEXAFLUORIDE
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
Route
INTRAVENOUS; INTRAVESICAL
Labeler
BRACCO DIAGNOSTICS INC
Application
NDA203684
Marketing category
NDA
Marketing start
2021-04-01
Substance
DISTEAROYLPHOSPHATIDYLCHOLINE, DL-; SODIUM 1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHO-(1'-RAC-GLYCEROL); SULFUR HEXAFLUORIDE
Active strength
.19; .19; 60.7 mg/mg; mg/mg; mg/mg
Pharmacologic classes
Contrast Agent for Ultrasound Imaging [EPC], Ultrasound Contrast Activity [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lumason
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DISTEAROYLPHOSPHATIDYLCHOLINE, DL-.19 mg/mg
SODIUM 1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHO-(1'-RAC-GLYCEROL).19 mg/mg
SULFUR HEXAFLUORIDE60.7 mg/mg

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEAG959U971, 841B886EJ7, WS7LR3I1D6

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f8f6af59-3ac0-4f91-bbb3-7b013673234dProduct name120170428

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0270-7097-072022-08-26C16284748780-1e4f33bdf-aec0-d8a0-e053-dadaa90a6e4eThese 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 use Initial U.S. Approval: 2014
0270-7097-082022-08-26C16284748780-1e4f33bdf-9d4d-d8a0-e053-dadaa90a6e4eThese 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 use Initial U.S. Approval: 2014
0270-7097-072022-07-29C16284748780-1e4f33bdf-aec0-d8a0-e053-dadaa90a6e4eThese 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 use Initial U.S. Approval: 2014
0270-7097-082022-07-29C16284748780-1e4f33bdf-9d4d-d8a0-e053-dadaa90a6e4eThese 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 use Initial U.S. Approval: 2014

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0270-7097-07LumaSon20 in 1 BOXINJECTION, POWDER, LYOPHILIZED,2019
0270-7097-07LumaSon25 mg in 1 VIALINJECTION, POWDER, LYOPHILIZED,2519
0270-7097-08Lumason20 in 1 BOXINJECTION, POWDER, LYOPHILIZED,2010
0270-7097-08Lumason25 mg in 1 VIALINJECTION, POWDER, LYOPHILIZED,2510

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0270-7097-07EA - Each0270-70975f9ed3f8-b290-480d-a0af-50b0e2764f1712021-06-02
0270-7097-08EA - Each0270-7097eb1f53fc-9f96-4ba8-8f2a-ef5d443ca17612021-06-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHO-(1'-RAC-GLYCEROL), SODIUM SALTACTIVE INGREDIENT841B886EJ7LUMASON (SULFUR HEXAFLUORIDE) KIT [BRACCO DIAGNOSTICS INC]1
DISTEAROYLPHOSPHATIDYLCHOLINE, DL-ACTIVE INGREDIENTEAG959U971LUMASON (SULFUR HEXAFLUORIDE) KIT [BRACCO DIAGNOSTICS INC]1
SULFUR HEXAFLUORIDEACTIVE INGREDIENTWS7LR3I1D6LUMASON (SULFUR HEXAFLUORIDE) KIT [BRACCO DIAGNOSTICS INC]1
1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHO-(1'-RAC-GLYCEROL), SODIUM SALTACTIVE MOIETY841B886EJ7LUMASON (SULFUR HEXAFLUORIDE) KIT [BRACCO DIAGNOSTICS INC]1
DISTEAROYLPHOSPHATIDYLCHOLINE, DL-ACTIVE MOIETYEAG959U971LUMASON (SULFUR HEXAFLUORIDE) KIT [BRACCO DIAGNOSTICS INC]1
SULFUR HEXAFLUORIDEACTIVE MOIETYWS7LR3I1D6LUMASON (SULFUR HEXAFLUORIDE) KIT [BRACCO DIAGNOSTICS INC]1
PALMITIC ACIDINACTIVE INGREDIENT2V16EO95H1LUMASON (SULFUR HEXAFLUORIDE) KIT [BRACCO DIAGNOSTICS INC]1
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95LUMASON (SULFUR HEXAFLUORIDE) KIT [BRACCO DIAGNOSTICS INC]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XLUMASON (SULFUR HEXAFLUORIDE) KIT [BRACCO DIAGNOSTICS INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0270-7097LUMASON (SULFUR HEXAFLUORIDE) KIT LUMASON (SULFUR HEXAFLUORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION [BRACCO DIAGNOSTICS INC]18Current NDC, Legacy NDC, 2 package rows20230817_7c679424-c3f7-ed02-892f-20ca0d775089.zip
0270-7097LUMASON (SULFUR HEXAFLUORIDE) KIT LUMASON (SULFUR HEXAFLUORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION [BRACCO DIAGNOSTICS INC]9Current NDC, Legacy NDC, 2 package rows20231128_69822a55-226c-f133-e3b8-2b5826667c5b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0270-7097-070027070970720 VIAL in 1 BOX (0270-7097-07) / 25 mg in 1 VIAL20 vial2021-04-010000-00-00NoNoCurrent
0270-7097-080027070970820 VIAL in 1 BOX (0270-7097-08) / 25 mg in 1 VIAL20 vial2021-04-010000-00-00NoNoCurrent