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United States · US · US:80534-1000_2d171c31-4d16-4bc1-9b90-b69631feadd5
XENOVIEW
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPolarean, Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11805341000150 BAG in 1 CARTON (80534-1000-1) / 1 L in 1 BAG
- ndc11805341000250 BAG in 1 CARTON (80534-1000-2) / 1 L in 1 BAG
Annotations
UNII (FDA Substance ID)
726Q6M95ZA
XENON XE-129, HYPERPOLARIZED
Orange Book
N214375
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "726Q6M95ZA",
"rxcui": null,
"inchikey": "FHNFHKCVQCLJFQ-YPZZEJLDSA-N",
"display_name": "XENON XE-129, HYPERPOLARIZED",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "RESPIRATORY (INHALATION)",
"spl_meta": {
"70e33fe3-c722-439b-b3db-c2a22f229c8a": {
"match": "brand_token",
"title": "XENOVIEW (XENON XE 129 HYPERPOLARIZED) GAS [POLAREAN, INC.]",
"spl_version": "5",
"published_date": "2025-06-18"
}
},
"productid": "80534-1000_2d171c31-4d16-4bc1-9b90-b69631feadd5",
"productndc": "80534-1000",
"dosage_form": "GAS",
"orange_book": {
"appl_no": "214375",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "N/A",
"product_no": "001",
"approval_date": "Dec 23, 2022"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "XENON XE-129, HYPERPOLARIZED",
"proprietary_name": "XENOVIEW",
"active_ingred_unit": "mL/L",
"application_number": "NDA214375",
"marketing_category": "NDA",
"nonproprietary_name": "xenon Xe 129 hyperpolarized",
"start_marketing_date": "20221223",
"active_numerator_strength": "75"
}Access this data programmatically
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