Medicine
Roflumilast 500 mcg tablet
Roflumilast 500 mcg tablet is a generic prescription medicine for oral use, made by 14 labelers, 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 roflumilast tablets at 20° - 25°C (68° - 77°F), excursions permitted to…
Key facts
- Active ingredient (INN)
- Roflumilast
- Brand
- Sold under the generic name
- Strength
- 500 mcg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 30 tablets, 90 tablets, 500 tablets and 33 more
- Manufacturers
- Ascend LaboratoriesIndiaMicro LabsIndiaZydus LifesciencesIndiaCamber PharmaceuticalsIndiaJubilant Cadista PharmaceuticalsIndiaNovadoz PharmaceuticalsIndiaAurobindo PharmaIndiaMajor PharmaceuticalsAmici PharmaAvKARE
- Origin register
- US FDA, United States
- Storage
- Store roflumilast 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
- 10 May 2022
- Identifiers
- RxCUI 1091839, 2001319DailyMed set ID e87287bd-eae3-46c3-9072-04800aeabf40, aaa81c1b-f63d-4e61-8bfa-9d42d92043c7, 913f1b95-9c46-40d5-a6e9-cff2e5e07eaa +13NDC 70771-1674, 59746-802, 60687-786 +13Application ANDA208303, ANDA208236, ANDA208213 +6
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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 30 tablet in 1 bottle | 68382-969-06 | Zydus LifesciencesIndia | 3 October 2022 |
| 90 tablet in 1 bottle | 68382-969-16 | Zydus LifesciencesIndia | 3 October 2022 |
| 30 tablet in 1 bottle | 70771-1674-3 | Zydus LifesciencesIndia | 3 October 2022 |
| 90 tablet in 1 bottle | 70771-1674-9 | Zydus LifesciencesIndia | 3 October 2022 |
| 500 tablet in 1 bottle | 67877-480-05 | Ascend LaboratoriesIndia | 14 March 2025 |
| 30 tablet in 1 bottle | 67877-480-30 | Ascend LaboratoriesIndia | 14 March 2025 |
| 1 blister pack in 1 carton / 10 tablet in 1 blister pack | 67877-480-33 | Ascend LaboratoriesIndia | 14 March 2025 |
| 90 tablet in 1 bottle | 67877-480-90 | Ascend LaboratoriesIndia | 14 March 2025 |
| 30 tablet in 1 bottle | 59651-275-30 | Aurobindo PharmaIndia | 17 April 2023 |
| 90 tablet in 1 bottle | 59651-275-90 | Aurobindo PharmaIndia | 17 April 2023 |
| 30 tablet in 1 bottle | 31722-623-30 | Camber PharmaceuticalsIndia | 15 October 2022 |
| 100 blister pack in 1 carton / 10 tablet in 1 blister pack | 31722-623-32 | Camber PharmaceuticalsIndia | 15 October 2022 |
| 90 tablet in 1 bottle | 31722-623-90 | Camber PharmaceuticalsIndia | 15 October 2022 |
| 500 tablet in 1 bottle | 59746-802-05 | Jubilant Cadista PharmaceuticalsIndia | 2 February 2026 |
| 30 tablet in 1 bottle | 59746-802-30 | Jubilant Cadista PharmaceuticalsIndia | 2 February 2026 |
| 90 tablet in 1 bottle | 59746-802-90 | Jubilant Cadista PharmaceuticalsIndia | 2 February 2026 |
| 500 tablet in 1 bottle | 42571-259-05 | Micro LabsIndia | 19 October 2022 |
| 11 blister pack in 1 carton / 10 tablet in 1 blister pack | 42571-259-17 | Micro LabsIndia | 19 October 2022 |
| 30 tablet in 1 bottle | 42571-259-30 | Micro LabsIndia | 19 October 2022 |
| 90 tablet in 1 bottle | 42571-259-90 | Micro LabsIndia | 19 October 2022 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 72205-200-06 | Novadoz PharmaceuticalsIndia | 24 September 2022 |
| 30 tablet in 1 bottle | 72205-200-30 | Novadoz PharmaceuticalsIndia | 24 September 2022 |
| 90 tablet in 1 bottle | 72205-200-90 | Novadoz PharmaceuticalsIndia | 24 September 2022 |
| 30 tablet in 1 bottle | 69292-631-30 | Amici Pharma | 5 February 2026 |
| 90 tablet in 1 bottle | 69292-631-90 | Amici Pharma | 5 February 2026 |
| 30 tablet in 1 bottle | 43547-005-03 | Solco Healthcare | 10 May 2022 |
| 90 tablet in 1 bottle | 43547-005-09 | Solco Healthcare | 10 May 2022 |
| 30 tablet in 1 bottle | 0904-7399-46 | Major Pharmaceuticals | 26 December 2023 |
| 90 tablet in 1 bottle | 0904-7399-89 | Major Pharmaceuticals | 26 December 2023 |
| 30 tablet in 1 bottle | 0904-7483-03 | Major Pharmaceuticals | 22 May 2024 |
| 90 tablet in 1 bottle | 0904-7483-89 | Major Pharmaceuticals | 22 May 2024 |
| 30 blister pack in 1 carton / 1 tablet in 1 blister pack | 60687-786-21 | American Health Packaging | 7 December 2023 |
| 30 tablet in 1 bottle | 73190-087-30 | AvKARE | 24 June 2026 |
| 90 tablet in 1 bottle | 73190-087-90 | AvKARE | 24 June 2026 |
| 30 tablet in 1 bottle | 72162-2385-3 | Bryant Ranch Prepack | 15 August 2024 |
| 90 tablet in 1 bottle | 51407-975-90 | Golden State Medical Supply | 13 February 2025 |
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 Roflumilast 500 mcg tablet for your hospital or patient?
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