Medicine
Daliresp 500 mcg tablet
Daliresp 500 mcg tablet is a prescription medicine containing Roflumilast for oral use, marketed by AstraZeneca Pharmaceuticals, 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 DALIRESP tablets at 20° - 25°C (68° - 77°F), excursions permitted to 15°…
Key facts
- Active ingredient (INN)
- Roflumilast
- Brand
- Daliresp
- Strength
- 500 mcg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 30 tablets, 90 tablets
- Marketing authorisation holder
- AstraZeneca Pharmaceuticals
- Manufacturer
- AstraZeneca Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store DALIRESP tablets at 20° - 25°C (68° - 77°F), excursions permitted to 15° - 30°C (59° - 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- R03DX07 Roflumilast
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 July 2015
- Identifiers
- RxCUI 1091839, 1091843, 2001319 +1DailyMed set ID c9a1d0a8-581f-4f91-a2b8-f419192d0ebfNDC 0310-0095Application NDA022522
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 |
|---|---|---|---|
| 30 tablet in 1 bottle, plastic | 0310-0095-30 | AstraZeneca Pharmaceuticals | 1 July 2015 |
| 90 tablet in 1 bottle, plastic | 0310-0095-90 | AstraZeneca Pharmaceuticals | 1 July 2015 |
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 Roflumilast 500 mcg tablet.
Other strengths and forms of Roflumilast
Clinical summary
Roflumilast is a phosphodiesterase 4 inhibitor indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations, among other approved uses. MedsAcross supplies Roflumilast 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 RoflumilastFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Daliresp prescribing information (AstraZeneca Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Daxas: European public assessment report (EPAR) · European Medicines Agency
Need Daliresp 500 mcg tablet 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.