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United States · US · US:72385-002_45245ace-7b4e-290f-e063-6394a90a8c7e

GENOSYL

Orange BookUNIISPLATC R07AX01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerVERO BIOTECH, INC.
CountryUS (United States)
ATC codeR07AX01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7238500201
    216 L in 1 CARTRIDGE (72385-002-01)

Annotations

UNII (FDA Substance ID)
31C4KY9ESH
NITRIC OXIDE
RxCUI 7442
Orange Book
N202860
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "31C4KY9ESH",
    "rxcui": "7442",
    "inchikey": "MWUXSHHQAYIFBG-UHFFFAOYSA-N",
    "display_name": "NITRIC OXIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "RESPIRATORY (INHALATION)",
  "spl_meta": {
    "c9560c54-9e28-4039-a4e5-5000c41c6c85": {
      "match": "brand_token",
      "title": "GENOSYL (NITRIC OXIDE) GAS [VERO BIOTECH, INC.]",
      "spl_version": "9",
      "published_date": "2025-12-12"
    }
  },
  "productid": "72385-002_45245ace-7b4e-290f-e063-6394a90a8c7e",
  "productndc": "72385-002",
  "dosage_form": "GAS",
  "orange_book": {
    "appl_no": "202860",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "800PPM",
        "product_no": "001",
        "approval_date": "Dec 20, 2019"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NITRIC OXIDE",
  "proprietary_name": "GENOSYL",
  "active_ingred_unit": "mg/L",
  "application_number": "NDA202860",
  "marketing_category": "NDA",
  "nonproprietary_name": "nitric oxide",
  "start_marketing_date": "20221228",
  "active_numerator_strength": ".98"
}

Related drugs

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