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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

  • ndc11
    8053463501
    1 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"
}

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