Noxivent

Noxivent is an FDA-registered drug product whose active ingredient is NITRIC OXIDE. It is labelled by VERO BIOTECH, INC. taken by respiratory (inhalation) and marketed as a human prescription drug product. Identifiers on file: NDC 72385-102, application ANDA207141, label effective 20260420. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing NITRIC OXIDE are most often described in connection with: usage noxivent, vasodilator indicated, improve oxygenation, extracorporeal membrane, near-term weeks, gestation neonates, hypoxic respiratory, failure associated. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

INDICATIONS AND USAGE Noxivent ™ is a vasodilator 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.

DOSAGE AND ADMINISTRATION The recommended dose is 20 ppm, maintained for up to 14 days or until the underlying oxygen desaturation has resolved ( 2.1 ). Doses greater than 20 ppm are not recommended ( 2.1 , 5.2 ) Administration: • Avoid abrupt discontinuation ( 2.2 , 5.1 ).

CONTRAINDICATIONS Neonates dependent on right-to-left shunting of blood ( 4 ).

ADVERSE REACTIONS The most common adverse reaction is hypotension. ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact contact Vero Biotech at 1-833-669-8368 and http://www.vero-biotech.com/ or FDA at 1-800-FDA-1088 or or www.fda.gov/medwatch .

What is Noxivent used for?
INDICATIONS AND USAGE Noxivent ™ is a vasodilator 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.

Who makes Noxivent?
VERO BIOTECH, INC. is the labeler of record for Noxivent.

What form does Noxivent come in?
administered by respiratory (inhalation). Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Noxivent prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has Noxivent been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.