Medicine
Entacapone 200 mg tablet
Entacapone 200 mg tablet is a generic prescription medicine for oral use, made by 13 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), excursions permitted to 15° to 30°C (59°…
Key facts
- Active ingredient (INN)
- Entacapone
- Brand
- Sold under the generic name
- Strength
- 200 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 1000 tablets, 500 tablets and 15 more
- Manufacturers
- Alembic PharmaceuticalsIndiaAurobindo PharmaIndiaMacleods PharmaceuticalsIndiaAjanta PharmaIndiaSun Pharmaceutical IndustriesIndiaAmerican Health PackagingAphena Pharma Solutions - TennesseeAvPAKLannettMajor Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F) Manufactured for: Macleods Pharma USA, Inc.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N04BX02 Entacapone
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 April 2013
- Identifiers
- RxCUI 317094DailyMed set ID 56327e32-3b06-4144-91a0-bb1908842e33, 3d4ec829-7835-4d59-bc5b-6ce38811fba7, d9cc1327-5474-4136-970a-ec40c41975b2 +11NDC 33342-260, 60687-188, 65862-654 +11Application ANDA207210, ANDA203437, ANDA212601 +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 | 46708-478-31 | Alembic PharmaceuticalsIndia | 6 January 2022 |
| 1000 tablet, film coated in 1 bottle | 46708-478-91 | Alembic PharmaceuticalsIndia | 6 January 2022 |
| 100 tablet, film coated in 1 bottle | 62332-478-31 | Alembic PharmaceuticalsIndia | 6 January 2022 |
| 1000 tablet, film coated in 1 bottle | 62332-478-91 | Alembic PharmaceuticalsIndia | 6 January 2022 |
| 100 tablet in 1 bottle | 27241-049-10 | Ajanta PharmaIndia | 31 August 2017 |
| 100 tablet, film coated in 1 bottle | 65862-654-01 | Aurobindo PharmaIndia | 19 June 2015 |
| 1000 tablet, film coated in 1 bottle | 65862-654-99 | Aurobindo PharmaIndia | 19 June 2015 |
| 100 tablet in 1 bottle | 33342-260-11 | Macleods PharmaceuticalsIndia | 6 June 2017 |
| 500 tablet in 1 bottle | 33342-260-15 | Macleods PharmaceuticalsIndia | 6 June 2017 |
| 100 tablet, film coated in 1 bottle | 47335-007-88 | Sun Pharmaceutical IndustriesIndia | 1 April 2013 |
| 100 tablet, film coated in 1 bottle, plastic | 0527-1830-37 | Lannett | 20 December 2018 |
| 100 tablet, film coated in 1 bottle, plastic | 64980-722-01 | Rising Pharma Holdings | 23 April 2026 |
| 100 tablet, film coated in 1 bottle | 0781-5578-01 | Sandoz | 4 June 2014 |
| 30 blister pack in 1 box, unit-dose / 1 tablet, film coated in 1 blister pack | 60687-188-21 | American Health Packaging | 2 June 2016 |
| 3600 tablet, film coated in 1 bottle | 71610-247-83 | Aphena Pharma Solutions - Tennessee | 7 March 2019 |
| 50 blister pack in 1 box, unit-dose / 1 tablet, film coated in 1 blister pack | 50268-295-15 | AvPAK | 5 December 2016 |
| 30 blister pack in 1 carton / 1 tablet, film coated in 1 blister pack | 0904-6822-07 | Major Pharmaceuticals | 2 May 2024 |
| 30 tablet in 1 blister pack | 0615-8298-39 | Vangard Labs | 1 July 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
Clinical summary
Entacapone is a catechol-O-methyltransferase inhibitor indicated as an adjunct to levodopa and carbidopa to treat end-of-dose “wearing-off” in patients with Parkinson’s disease. It is available as tablets for oral use. MedsAcross supplies Entacapone 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 EntacaponeFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Entacapone prescribing information (Sun Pharmaceutical Industries) · U.S. National Library of Medicine, DailyMed
- Comtan: European public assessment report (EPAR) · European Medicines Agency
- Comtess: European public assessment report (EPAR) · European Medicines Agency
Need Entacapone 200 mg tablet for your hospital or patient?
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