Quick answers
- What is Nitric oxide used for?
- The FDA-approved label (Inomax, INO Therapeutics LLC, December 12, 2025) says: “INOmax ® 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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Nitric oxide have a boxed warning?
- No. None of the 8 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Nitric oxide?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Nitric oxide been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Nitric oxide?
- 4 companies list prescription products of Nitric oxide in the FDA NDC Directory, including Vero Biotech, Inc., Airgas Therapeutics, LLC and INO Therapeutics LLC.
What Nitric oxide is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
INOmax ® 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 label: Inomax, INO Therapeutics LLC, effective December 12, 2025. Read the full label on DailyMed →
The FDA has 8 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 8 FDA labels for this medicine have a boxed warning.
Forms and how it is given
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Vero Biotech, Inc.4 products
- Airgas Therapeutics, LLC2 products
- INO Therapeutics LLC2 products
- Linde Gas & Equipment Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020845 INOMAX | Mallinckrodt Ireland | December 23, 1999 | 12, latest January 17, 2023 2023: Manufacturing (CMC) · 2019: Labeling · 2016: Labeling |
| NDA202860 GENOSYL | Vero Biotech Inc | December 20, 2019 | — |
Generic approvals (2)
- ANDA207141Vero Biotech Inc · October 2, 2018
- ANDA203144Airgas Therap · July 27, 2023
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 582608, 827693, 2702871, 2743256 |
|---|---|
| SPL set ID of the quoted label | 762b51be-1893-4cd1-9511-e645fc420d3a |
| FDA labels (SPL) | 8 |
| FDA applications | NDA020845, NDA202860, 2 ANDA |
| Active ingredients (FDA) | NITRIC OXIDE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Inomax, INO Therapeutics LLC, effective December 12, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →