xenoview

Generic: xenon xe 129 hyperpolarized

Labeler: polarean, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name xenoview
Generic Name xenon xe 129 hyperpolarized
Labeler polarean, inc.
Dosage Form GAS
Routes
RESPIRATORY (INHALATION)
Active Ingredients

helium 5651.5 L/1, nitrogen 635 L/1, xenon xe-129 63.5 L/1

Manufacturer
Polarean, Inc.

Identifiers & Regulatory

Product NDC 80534-6350
Product ID 80534-6350_2d171c31-4d16-4bc1-9b90-b69631feadd5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA214375
Listing Expiration 2026-12-31
Marketing Start 2022-12-23

Pharmacologic Class

Established (EPC)
hyperpolarized contrast agent [epc]
Mechanism of Action
magnetic resonance contrast activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 805346350
Hyphenated Format 80534-6350

Supplemental Identifiers

UNII
206GF3GB41 N762921K75 9C7571UDT5 726Q6M95ZA
NUI
N0000194089 N0000175862

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 xenoview (source: ndc)
Generic Name xenon xe 129 hyperpolarized (source: ndc)
Application Number NDA214375 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 5651.5 L/1
  • 635 L/1
  • 63.5 L/1
source: ndc
Packaging
  • 1 GAS in 1 CYLINDER (80534-6350-1)
source: ndc

Packages (1)

80534-6350-1 1 GAS in 1 CYLINDER (80534-6350-1)

Ingredients (3)

helium (5651.5 L/1) nitrogen (635 L/1) xenon xe-129 (63.5 L/1)

Linked Drug Pages (1)

XENOVIEW ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "2d171c31-4d16-4bc1-9b90-b69631feadd5", "openfda": {"nui": ["N0000194089", "N0000175862"], "unii": ["206GF3GB41", "N762921K75", "9C7571UDT5", "726Q6M95ZA"], "spl_set_id": ["70e33fe3-c722-439b-b3db-c2a22f229c8a"], "pharm_class_epc": ["Hyperpolarized Contrast Agent [EPC]"], "pharm_class_moa": ["Magnetic Resonance Contrast Activity [MoA]"], "manufacturer_name": ["Polarean, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 GAS in 1 CYLINDER (80534-6350-1)", "package_ndc": "80534-6350-1", "marketing_start_date": "20221223"}], "brand_name": "XENOVIEW", "product_id": "80534-6350_2d171c31-4d16-4bc1-9b90-b69631feadd5", "dosage_form": "GAS", "product_ndc": "80534-6350", "generic_name": "xenon Xe 129 hyperpolarized", "labeler_name": "Polarean, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "XENOVIEW", "active_ingredients": [{"name": "HELIUM", "strength": "5651.5 L/1"}, {"name": "NITROGEN", "strength": "635 L/1"}, {"name": "XENON XE-129", "strength": "63.5 L/1"}], "application_number": "NDA214375", "marketing_category": "NDA", "marketing_start_date": "20221223", "listing_expiration_date": "20261231"}