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

xenon xe-129, hyperpolarized 75 mL/300mL

Manufacturer
Polarean, Inc.

Identifiers & Regulatory

Product NDC 80534-0300
Product ID 80534-0300_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 805340300
Hyphenated Format 80534-0300

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
  • 75 mL/300mL
source: ndc
Packaging
  • 50 BAG in 1 CARTON (80534-0300-1) / 300 mL in 1 BAG
source: ndc

Packages (1)

80534-0300-1 50 BAG in 1 CARTON (80534-0300-1) / 300 mL in 1 BAG

Ingredients (1)

xenon xe-129, hyperpolarized (75 mL/300mL)

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": "50 BAG in 1 CARTON (80534-0300-1)  / 300 mL in 1 BAG", "package_ndc": "80534-0300-1", "marketing_start_date": "20250530"}], "brand_name": "XENOVIEW", "product_id": "80534-0300_2d171c31-4d16-4bc1-9b90-b69631feadd5", "dosage_form": "GAS", "pharm_class": ["Hyperpolarized Contrast Agent [EPC]", "Magnetic Resonance Contrast Activity [MoA]"], "product_ndc": "80534-0300", "generic_name": "xenon Xe 129 hyperpolarized", "labeler_name": "Polarean, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "XENOVIEW", "active_ingredients": [{"name": "XENON XE-129, HYPERPOLARIZED", "strength": "75 mL/300mL"}], "application_number": "NDA214375", "marketing_category": "NDA", "marketing_start_date": "20221223", "listing_expiration_date": "20261231"}