Medicine
Pramipexole 4.5 mg extended-release tablet
Pramipexole 4.5 mg extended-release tablet is a generic prescription medicine for oral use, made by 5 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° to 25°C (68° to 77°F). Protect from exposure to high humidity…
Key facts
- Active ingredient (INN)
- Pramipexole
- Brand
- Sold under the generic name
- Strength
- 4.5 mg
- Dosage form
- Extended-release tablet
- Route
- Oral
- Packs
- 30 tablets, 10 blister pack and 4 more
- Manufacturers
- Alembic PharmaceuticalsIndiaMacleods PharmaceuticalsIndiaDr. Reddy's LaboratoriesIndiaIngenus PharmaceuticalsNorthStar RxLLC
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F). Protect from exposure to high humidity. Store in a safe place out of the reach of children.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N04BC05 Pramipexole
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 14 August 2015
- Identifiers
- RxCUI 901534, 901541, 901546 +4DailyMed set ID 00699692-532a-68fd-8a51-3770a81b2208, b6935240-ee81-49ef-adad-fb900d7f5127, 1d2b1d2c-ae22-424a-bad7-ce24a817b042 +3NDC 55111-615, 46708-580, 50742-337 +3Application ANDA203354, ANDA204518, ANDA213444 +1
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, extended release in 1 bottle | 46708-580-30 | Alembic PharmaceuticalsIndia | 3 January 2019 |
| 30 tablet, extended release in 1 bottle | 62332-159-30 | Alembic PharmaceuticalsIndia | 3 January 2019 |
| 30 tablet, extended release in 1 bottle | 55111-615-30 | Dr. Reddy's LaboratoriesIndia | 14 August 2015 |
| 30 tablet, extended release in 1 bottle | 33342-214-07 | Macleods PharmaceuticalsIndia | 24 August 2020 |
| 10 blister pack in 1 carton / 10 tablet, extended release in 1 blister pack | 33342-214-12 | Macleods PharmaceuticalsIndia | 24 August 2020 |
| 30 tablet, extended release in 1 bottle | 50742-337-30 | Ingenus Pharmaceuticals | 10 March 2022 |
| 30 tablet, extended release in 1 bottle | 16714-922-01 | NorthStar RxLLC | 6 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.
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 Pramipexole
Clinical summary
Pramipexole is a nonergot dopamine agonist indicated for the treatment of parkinson's disease (PD), among other approved uses. It is available as tablets and extended-release tablets for oral use. MedsAcross supplies Pramipexole 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 PramipexoleFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Pramipexole Dihydrochloride prescribing information (Torrent Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Mirapexin: European public assessment report (EPAR) · European Medicines Agency
- Sifrol: European public assessment report (EPAR) · European Medicines Agency
Need Pramipexole 4.5 mg extended-release 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.