LumaSon

Product NDC
0270-7099
11-digit product format
002707099
Labeler code
0270
Product ID
0270-7099_47b0f2df-0b6c-a221-750d-763d5ece665b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SULFUR HEXAFLUORIDE
Dosage form
KIT
Labeler
BRACCO DIAGNOSTICS INC
Application
NDA203684
Marketing category
NDA
Marketing start
2020-01-15
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

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
0270-7099-162022-08-26C16284748780-1e4f33bdf-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
0270-7099-732022-08-26C16284748780-1e4f33bdf-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
0270-7099-162022-07-29C16284748780-1e4f33bdf-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
0270-7099-732022-07-29C16284748780-1e4f33bdf-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
0270-7099-16LumaSon1 in 1 KITKIT119
0270-7099-16LumaSon5 in 1 BOXKIT519
0270-7099-73LumaSon5 in 1 BOXKIT510
0270-7099-73LumaSon1 in 1 KITKIT110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0270-7099-16EA - Each0270-709944aa2562-72b7-4524-a338-06ba42fda7fd12015-09-10
0270-7099-73EA - Each0270-70998d471263-7eb8-410f-8898-7ebf6b52279212021-03-02

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
0270-7099LUMASON (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
0270-7099LUMASON (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
0270-7099-16002707099165 KIT in 1 BOX (0270-7099-16) / 1 KIT in 1 KIT * 25 mg in 1 VIAL * 5 mL in 1 SYRINGE5 kit2015-01-150000-00-00NoNoCurrent
0270-7099-73002707099735 KIT in 1 BOX (0270-7099-73) / 1 KIT in 1 KIT * 25 mg in 1 VIAL * 5 mL in 1 SYRINGE5 kit2020-01-150000-00-00NoNoCurrent