lumason

Generic: sulfur hexafluoride

Labeler: bracco diagnostics inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name lumason
Generic Name sulfur hexafluoride
Labeler bracco diagnostics inc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
Routes
INTRAVENOUS INTRAVESICAL
Active Ingredients

distearoylphosphatidylcholine, dl- .19 mg/mg, sodium 1,2-dipalmitoyl-sn-glycero-3-phospho-(1'-rac-glycerol) .19 mg/mg, sulfur hexafluoride 60.7 mg/mg

Manufacturer
BRACCO DIAGNOSTICS INC

Identifiers & Regulatory

Product NDC 0270-7097
Product ID 0270-7097_5407234f-5a9d-9a66-2e42-6629c0c74aec
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA203684
Listing Expiration 2026-12-31
Marketing Start 2021-04-01

Pharmacologic Class

Established (EPC)
contrast agent for ultrasound imaging [epc]
Mechanism of Action
ultrasound contrast activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 02707097
Hyphenated Format 0270-7097

Supplemental Identifiers

UNII
EAG959U971 841B886EJ7 WS7LR3I1D6
NUI
N0000175864 N0000010259

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name lumason (source: ndc)
Generic Name sulfur hexafluoride (source: ndc)
Application Number NDA203684 (source: ndc)
Routes
INTRAVENOUS INTRAVESICAL
source: ndc

Resolved Composition

Strengths
  • .19 mg/mg
  • 60.7 mg/mg
source: ndc
Packaging
  • 20 VIAL in 1 BOX (0270-7097-07) / 25 mg in 1 VIAL
source: ndc

Packages (1)

0270-7097-07 20 VIAL in 1 BOX (0270-7097-07) / 25 mg in 1 VIAL

Ingredients (3)

distearoylphosphatidylcholine, dl- (.19 mg/mg) sodium 1,2-dipalmitoyl-sn-glycero-3-phospho-(1'-rac-glycerol) (.19 mg/mg) sulfur hexafluoride (60.7 mg/mg)

Linked Drug Pages (2)

LumaSon ndc-match (0.9) Lumason, LumaSon ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS", "INTRAVESICAL"], "spl_id": "5407234f-5a9d-9a66-2e42-6629c0c74aec", "openfda": {"nui": ["N0000175864", "N0000010259"], "unii": ["EAG959U971", "841B886EJ7", "WS7LR3I1D6"], "spl_set_id": ["7c679424-c3f7-ed02-892f-20ca0d775089"], "pharm_class_epc": ["Contrast Agent for Ultrasound Imaging [EPC]"], "pharm_class_moa": ["Ultrasound Contrast Activity [MoA]"], "manufacturer_name": ["BRACCO DIAGNOSTICS INC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 VIAL in 1 BOX (0270-7097-07)  / 25 mg in 1 VIAL", "package_ndc": "0270-7097-07", "marketing_start_date": "20210401"}], "brand_name": "LumaSon", "product_id": "0270-7097_5407234f-5a9d-9a66-2e42-6629c0c74aec", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION", "pharm_class": ["Contrast Agent for Ultrasound Imaging [EPC]", "Ultrasound Contrast Activity [MoA]"], "product_ndc": "0270-7097", "generic_name": "SULFUR HEXAFLUORIDE", "labeler_name": "BRACCO DIAGNOSTICS INC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LumaSon", "active_ingredients": [{"name": "DISTEAROYLPHOSPHATIDYLCHOLINE, DL-", "strength": ".19 mg/mg"}, {"name": "SODIUM 1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHO-(1'-RAC-GLYCEROL)", "strength": ".19 mg/mg"}, {"name": "SULFUR HEXAFLUORIDE", "strength": "60.7 mg/mg"}], "application_number": "NDA203684", "marketing_category": "NDA", "marketing_start_date": "20210401", "listing_expiration_date": "20261231"}