Medicine
Ongentys 50 mg capsule
Ongentys 50 mg capsule is a prescription medicine containing Opicapone for oral use, marketed by Amneal Pharmaceuticals, 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 between 15° to 30°C…
Key facts
- Active ingredient (INN)
- Opicapone
- Brand
- Ongentys
- Strength
- 50 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 30 capsules
- Marketing authorisation holder
- Amneal Pharmaceuticals
- Manufacturer
- Amneal Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C (59° to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N04BX04 Opicapone
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 5 April 2024
- Identifiers
- RxCUI 2362172, 2362178, 2362180 +1DailyMed set ID a511a531-112e-43f8-a43f-5334b0efe979NDC 64896-403Application NDA212489
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 30 capsule in 1 bottle | 64896-403-01 | Amneal Pharmaceuticals | 5 April 2024 |
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 Opicapone
Clinical summary
Opicapone is a catechol-O-methyltransferase inhibitor indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “off” episodes. It is available as capsules for oral use. MedsAcross supplies Opicapone 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 OpicaponeFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- ONGENTYS prescribing information (Amneal Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Ongentys: European public assessment report (EPAR) · European Medicines Agency
Need Ongentys 50 mg capsule 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.