Active ingredient
Nitric Oxide
9 finished FDA listings contain Nitric Oxide as their only active ingredient; 1 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- NITRIC OXIDE
- Dosage forms
- Gas
- Routes
- Respiratory (Inhalation)
- Manufacturers / labelers
- 4
- Strengths listed
- .8 ml/100l · .98 mg/l · 6 mg/l · 800 mg/l
- Brand names in FDA listings
- Genosyl, Inomax, Noxivent, Ulspira
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 7442
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 020845 | MALLINCKRODT IRELAND | 1999-12-23 | 2 |
| ANDA 207141 | VERO BIOTECH INC | 2018-10-02 | 2 |
| NDA 202860 | VERO BIOTECH INC | 2019-12-20 | 3 |
| ANDA 203144 | AIRGAS THERAP | 2023-07-27 | 2 |
Official labeling on DailyMed
- NOXIVENT (NITRIC OXIDE) GAS [VERO BIOTECH, INC.] · version 1 · 2026-05-15
- INOMAX (NITRIC OXIDE) GAS [INO THERAPEUTICS LLC] · version 19 · 2025-12-15
- GENOSYL (NITRIC OXIDE) GAS [VERO BIOTECH, INC.] · version 9 · 2025-12-12
- GENOSYL (NITRIC OXIDE) GAS [VERO BIOTECH, INC.] · version 1 · 2025-12-12
- GENOSYL (NITRIC OXIDE) GAS [VERO BIOTECH, INC.] · version 6 · 2025-12-05
- NOXIVENT 102 GAS [LINDE GAS & EQUIPMENT INC] · version 9 · 2025-11-18
- ULSPIRA (NITRIC OXIDE) GAS [AIRGAS THERAPEUTICS, LLC] · version 15 · 2025-11-17
- ULSPIRA GAS [AIRGAS THERAPEUTICS, LLC] · version 32 · 2025-07-18
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.