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United States · US · US:82605-006_3a136eac-7cc3-31ea-e063-6294a90afb91

Ulspira

Orange BookUNIISPLATC R07AX01

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

Identification

ManufacturerAirgas Therapeutics, LLC
CountryUS (United States)
ATC codeR07AX01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    8260500601
    2138 L in 1 CYLINDER (82605-006-01)
  • ndc11
    8260500602
    362 L in 1 CYLINDER (82605-006-02)

Annotations

UNII (FDA Substance ID)
31C4KY9ESH
NITRIC OXIDE
RxCUI 7442
Orange Book
A203144
AA
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": {
    "2c605fc0-82be-09e0-e063-6394a90a63e9": {
      "match": "brand_token",
      "title": "ULSPIRA (NITRIC OXIDE) GAS [AIRGAS THERAPEUTICS, LLC]",
      "spl_version": "15",
      "published_date": "2025-11-17"
    }
  },
  "productid": "82605-006_3a136eac-7cc3-31ea-e063-6294a90afb91",
  "productndc": "82605-006",
  "dosage_form": "GAS",
  "orange_book": {
    "appl_no": "203144",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "800PPM",
        "product_no": "001",
        "approval_date": "Jul 27, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NITRIC OXIDE",
  "proprietary_name": "Ulspira",
  "active_ingred_unit": "mL/100L",
  "application_number": "ANDA203144",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ulspira",
  "start_marketing_date": "20230804",
  "active_numerator_strength": ".8"
}

Related drugs

Other records sharing ATC code R07AX01.

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