Medicine
Ropinirole 2 mg extended-release tablet
Ropinirole 2 mg extended-release tablet is a generic prescription medicine for oral use, made by 7 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 at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C…
Key facts
- Active ingredient (INN)
- Ropinirole
- Brand
- Sold under the generic name
- Strength
- 2 mg
- Dosage form
- Extended-release tablet
- Route
- Oral
- Packs
- 100 tablets, 30 tablets, 500 tablets and 19 more
- Manufacturers
- Alembic PharmaceuticalsIndiaDr. Reddy's LaboratoriesIndiaActavis PharmaBryant Ranch PrepackAvKAREElite LaboratoriesSolco Healthcare
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N04BC04 Ropinirole
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 6 June 2012
- Identifiers
- RxCUI 799054, 799055, 799056 +2DailyMed set ID 213dd2f4-4a71-456c-b3c7-b709c7bd7445, 2e01dbdd-f439-45d7-9085-2d92a1a1fee2, 300946bf-2f83-471d-868d-9820b65c52bb +5NDC 43547-554, 46708-262, 0228-3658 +5Application ANDA204413, ANDA202786, ANDA090869 +2
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 |
|---|---|---|---|
| 100 tablet, film coated, extended release in 1 carton | 46708-262-10 | Alembic PharmaceuticalsIndia | 14 March 2013 |
| 30 tablet, film coated, extended release in 1 bottle | 46708-262-30 | Alembic PharmaceuticalsIndia | 14 March 2013 |
| 100 tablet, film coated, extended release in 1 bottle | 46708-262-31 | Alembic PharmaceuticalsIndia | 14 March 2013 |
| 500 tablet, film coated, extended release in 1 bottle | 46708-262-71 | Alembic PharmaceuticalsIndia | 14 March 2013 |
| 90 tablet, film coated, extended release in 1 bottle | 46708-262-90 | Alembic PharmaceuticalsIndia | 14 March 2013 |
| 1000 tablet, film coated, extended release in 1 bottle | 46708-262-91 | Alembic PharmaceuticalsIndia | 14 March 2013 |
| 100 tablet, film coated, extended release in 1 carton | 62332-107-10 | Alembic PharmaceuticalsIndia | 20 June 2020 |
| 30 tablet, film coated, extended release in 1 bottle | 62332-107-30 | Alembic PharmaceuticalsIndia | 20 June 2020 |
| 100 tablet, film coated, extended release in 1 bottle | 62332-107-31 | Alembic PharmaceuticalsIndia | 20 June 2020 |
| 500 tablet, film coated, extended release in 1 bottle | 62332-107-71 | Alembic PharmaceuticalsIndia | 20 June 2020 |
| 90 tablet, film coated, extended release in 1 bottle | 62332-107-90 | Alembic PharmaceuticalsIndia | 20 June 2020 |
| 1000 tablet, film coated, extended release in 1 bottle | 62332-107-91 | Alembic PharmaceuticalsIndia | 20 June 2020 |
| 500 tablet, film coated, extended release in 1 bottle | 55111-659-05 | Dr. Reddy's LaboratoriesIndia | 6 June 2012 |
| 30 tablet, film coated, extended release in 1 bottle | 55111-659-30 | Dr. Reddy's LaboratoriesIndia | 6 June 2012 |
| 90 tablet, film coated, extended release in 1 bottle | 55111-659-90 | Dr. Reddy's LaboratoriesIndia | 6 June 2012 |
| 30 tablet, film coated, extended release in 1 bottle | 0228-3658-03 | Actavis Pharma | 23 August 2012 |
| 90 tablet, film coated, extended release in 1 bottle | 0228-3658-09 | Actavis Pharma | 23 August 2012 |
| 30 tablet, extended release in 1 bottle | 64850-250-30 | Elite Laboratories | 10 November 2025 |
| 30 tablet, extended release in 1 bottle | 43547-554-03 | Solco Healthcare | 22 March 2022 |
| 30 tablet, film coated, extended release in 1 bottle | 42291-713-30 | AvKARE | 1 November 2023 |
| 30 tablet, extended release in 1 bottle | 72162-2602-3 | Bryant Ranch Prepack | 17 April 2026 |
| 90 tablet, extended release in 1 bottle | 72162-2602-9 | Bryant Ranch Prepack | 17 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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 19 September 1997 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
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
Other strengths and forms of Ropinirole
Clinical summary
Ropinirole is a nonergot dopamine agonist indicated for the treatment of Parkinson’s disease (PD) and moderate-to-severe primary Restless Legs Syndrome (RLS), among other approved uses. It is available as tablets and extended-release tablets for oral use. MedsAcross supplies Ropinirole 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 RopiniroleFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- ROPINIROLE prescribing information (Alembic Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Ropinirole 2 mg extended-release tablet for your hospital or patient?
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