Medicine
Ohtuvayre 3 mg/2.5 mL inhalation suspension
Ohtuvayre 3 mg/2.5 mL inhalation suspension is a prescription medicine containing Ensifentrine for inhalation use, marketed by Merck Sharp & Dohme, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Do not freeze. Store at controlled room temperature (68°F to 77°F [20°C to…
Key facts
- Active ingredient (INN)
- Ensifentrine
- Brand
- Ohtuvayre
- Strength
- 3 mg/2.5 mL
- Dosage form
- Inhalation suspension
- Route
- Inhalation
- Packs
- 60 pouches
- Marketing authorisation holder
- Merck Sharp & Dohme
- Manufacturer
- Merck Sharp & Dohme
- Origin register
- US FDA, United States
- Storage
- Do not freeze. Store at controlled room temperature (68°F to 77°F [20°C to 25°C], excursions permitted from 59ºF to 86ºF [15ºC to 30ºC]). Store OHTUVAYRE in the protective foil pouch. Protect from direct sunlight and excessive heat. Do not store upside down.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- R03BX Asthma and COPD medicines, subgroup R03B, subgroup R03BX
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 26 June 2024
- Identifiers
- RxCUI 2687221, 2687226DailyMed set ID e6433c98-41a0-4f99-8f7f-d0e9db6e3f40NDC 83034-003Application NDA217389
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 60 pouch in 1 carton / 1 ampule in 1 pouch / 2.5 mL in 1 ampule | 83034-003-60 | Merck Sharp & Dohme | 26 June 2024 |
| 60 pouch in 1 carton / 5 ampule in 1 pouch / 2.5 mL in 1 ampule | 83034-003-65 | Merck Sharp & Dohme | 26 June 2024 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Clinical summary
Ensifentrine is a phosphodiesterase 3 inhibitor indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. It is available as inhalation suspension. MedsAcross supplies Ensifentrine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about EnsifentrineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Ohtuvayre prescribing information (Merck Sharp & Dohme) · U.S. National Library of Medicine, DailyMed
Need Ohtuvayre 3 mg/2.5 mL inhalation suspension for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.