Prescription medicine
Nitric oxide Brand names: Genosyl, Inomax, Ulspira, Noxivent
Nitric oxide (Inomax) is a prescription medicine with an FDA approval on record since 1999. FDA's NDC Directory lists it from 3 generic labelers.
- Generic listed
Check it at the source: the nitric oxide FDA label on DailyMed (effective December 11, 2025, VERO BIOTECH, INC.); the NDA 20845 record on Drugs@FDA; every nitric oxide label on DailyMed.
Highlights of the record
FDA label of December 11, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageGENOSYL ® is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents.
Forms and strengths
- 0.98 mg
- 6 mg
- 800 mg
- 0.8 ml
Gas.
On the market
- Earliest approval on file
- December 23, 1999 Inomax, Mallinckrodt Ireland; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 2 first October 2, 2018; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 4 of which 3 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- November 3, 2036 Inomax gas; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 4,473 through July 30, 2026
What is nitric oxide used for?
From the label: indications and usageGENOSYL ® is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents. […]
FDA pharmacologic class: Vasodilator.
Source: FDA drug label (GENOSYL), VERO BIOTECH, INC., effective December 11, 2025 (SPL set c9560c54-9e28-4039-a4e5-5000c41c6c85), via openFDA; the full label on DailyMed
Is there a generic for nitric oxide (Inomax)?
The FDA approved the first generic nitric oxide on October 2, 2018. 2 generic applications are approved; 2 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists nitric oxide from 3 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 16 patents for Inomax gas: the compound patent runs to June 30, 2029 (pediatric exclusivity to December 30, 2029), and the last listed entry to November 3, 2036; a patent listed only for Genosyl gas runs to July 22, 2040. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1999 earliest approval on file
- 2018 first generic approved
- 2036 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the nitric oxide label say about other medicines?
The nitric oxide label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 22 other medicines name nitric oxide. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Prilocaine | drug interactions | Nitric oxide donor agents such as prilocaine, sodium nitroprusside and nitroglycerine may increase the risk of developing methemoglobinemia. |
| Sodium nitroprusside | drug interactions | Nitric oxide donor agents such as prilocaine, sodium nitroprusside and nitroglycerine may increase the risk of developing methemoglobinemia. |
Other labels that name nitric oxide
Source: FDA drug label (GENOSYL), VERO BIOTECH, INC., effective December 11, 2025 (SPL set c9560c54-9e28-4039-a4e5-5000c41c6c85), via openFDA; the full label on DailyMed
What do FAERS reports show for nitric oxide?
The FDA Adverse Event Reporting System holds 4,473 reports that list nitric oxide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,320 are coded as a death and 712 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other vasodilators
- the pharmacologic class, with prices and generics
- Nitric oxide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other