Medicine
Ropinirole 3 mg tablet
Ropinirole 3 mg 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 room temperature between 20°C and 25°C (68°F and 77°F), excursions…
Key facts
- Active ingredient (INN)
- Ropinirole
- Brand
- Sold under the generic name
- Strength
- 3 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 1000 tablets, 500 tablets and 9 more
- Manufacturers
- Alembic PharmaceuticalsIndiaGlenmark PharmaceuticalsIndiaAccord HealthcareIndiaSolco HealthcareBionpharmaCouplerMarlex Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at room temperature between 20°C and 25°C (68°F and 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light and moisture.
- 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
- 25 February 2010
- Identifiers
- RxCUI 283858, 312845, 312846 +4DailyMed set ID 7734ef0b-584f-42dd-a8b5-adbdf4e4df93, 4e6b070c-50a6-4742-af3c-59b45c45735e, 9a25f575-09ab-4d32-b73e-5426f08c00c4 +6NDC 43547-272, 69452-360, 46708-034 +6Application ANDA078110, ANDA079229, ANDA090429 +3
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 in 1 bottle | 46708-034-31 | Alembic PharmaceuticalsIndia | 12 September 2013 |
| 100 tablet, film coated in 1 bottle | 62332-034-31 | Alembic PharmaceuticalsIndia | 29 January 2016 |
| 100 tablet, film coated in 1 bottle | 16729-236-01 | Accord HealthcareIndia | 17 October 2018 |
| 100 tablet, film coated in 1 bottle | 68462-257-01 | Glenmark PharmaceuticalsIndia | 25 February 2010 |
| 1000 tablet, film coated in 1 bottle | 68462-257-10 | Glenmark PharmaceuticalsIndia | 25 February 2010 |
| 100 tablet, film coated in 1 bottle, plastic | 43547-272-10 | Solco Healthcare | 20 September 2011 |
| 500 tablet, film coated in 1 bottle, plastic | 43547-272-50 | Solco Healthcare | 20 September 2011 |
| 100 tablet, film coated in 1 bottle, plastic | 43547-599-10 | Solco Healthcare | 20 September 2011 |
| 500 tablet, film coated in 1 bottle, plastic | 43547-599-50 | Solco Healthcare | 20 September 2011 |
| 100 tablet, film coated in 1 bottle, plastic | 69452-360-20 | Bionpharma | 15 September 2022 |
| 30 tablet, film coated in 1 blister pack | 67046-1490-3 | Coupler | 29 January 2025 |
| 100 tablet, film coated in 1 bottle | 10135-677-01 | Marlex Pharmaceuticals | 15 March 2019 |
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 3 mg 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.