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United States · US · US:80534-6350_2d171c31-4d16-4bc1-9b90-b69631feadd5
XENOVIEW
Orange BookUNIISPLATC V03AN
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPolarean, Inc.
CountryUS (United States)
ATC codeV03AN
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1180534635011 GAS in 1 CYLINDER (80534-6350-1)
Annotations
UNII (FDA Substance ID)
206GF3GB41
HELIUM
RxCUI 5140
Orange Book
N214375
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "206GF3GB41",
"rxcui": "5140",
"inchikey": "SWQJXJOGLNCZEY-UHFFFAOYSA-N",
"display_name": "HELIUM",
"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": "80534-6350_2d171c31-4d16-4bc1-9b90-b69631feadd5",
"productndc": "80534-6350",
"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": "HELIUM; NITROGEN; XENON XE-129",
"proprietary_name": "XENOVIEW",
"active_ingred_unit": "L/1; L/1; L/1",
"application_number": "NDA214375",
"marketing_category": "NDA",
"nonproprietary_name": "xenon Xe 129 hyperpolarized",
"start_marketing_date": "20221223",
"active_numerator_strength": "5651.5; 635; 63.5"
}Related drugs
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