Medicine
Umeclidinium Ellipta 62.5 mcg inhalation powder
Umeclidinium Ellipta 62.5 mcg inhalation powder is a prescription medicine containing Umeclidinium for oral use, marketed by Prasco Laboratories, 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
Store at room temperature between 68°F and 77°F (20°C and 25°C), excursions…
Key facts
- Active ingredient (INN)
- Umeclidinium
- Brand
- Umeclidinium Ellipta
- Strength
- 62.5 mcg
- Dosage form
- Inhalation powder
- Route
- Oral
- Packs
- 1 tray
- Marketing authorisation holder
- Prasco Laboratories
- Manufacturer
- Prasco Laboratories
- Origin register
- US FDA, United States
- Storage
- Store at room temperature between 68°F and 77°F (20°C and 25°C), excursions permitted from 59°F to 86°F (15°C to 30°C). Store in a dry place away from direct heat or sunlight. Umeclidinium ELLIPTA should be stored inside the unopened moisture-protective foil tray and only removed from the tray immediately before initial use.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- R03BB07 Umeclidinium
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 6 April 2026
- Identifiers
- RxCUI 1539251DailyMed set ID 763388a5-cc89-4c25-8562-521df679b7e8NDC 66993-189Application NDA205382
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 |
|---|---|---|---|
| 1 tray in 1 carton / 1 inhaler in 1 tray / 30 aerosol, powder in 1 inhaler | 66993-189-97 | Prasco Laboratories | 6 April 2026 |
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
Alternatives
Other makers and brands of Umeclidinium 62.5 mcg inhalation powder.
Clinical summary
Umeclidinium is an anticholinergic indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). It is available as inhalation powder for oral use. MedsAcross supplies Umeclidinium 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 UmeclidiniumFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Umeclidinium Ellipta prescribing information (Prasco Laboratories) · U.S. National Library of Medicine, DailyMed
- Incruse Ellipta (previously Incruse): European public assessment report (EPAR) · European Medicines Agency
- Rolufta Ellipta (previously Rolufta): European public assessment report (EPAR) · European Medicines Agency
Need Umeclidinium Ellipta 62.5 mcg inhalation powder 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.