Medicine
Gocovri 68.5 mg capsule
Gocovri 68.5 mg capsule is a prescription medicine containing Amantadine for oral use, marketed by Supernus 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°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C…
Key facts
- Active ingredient (INN)
- Amantadine
- Brand
- Gocovri
- Strength
- 68.5 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 60 capsules
- Marketing authorisation holder
- Supernus Pharmaceuticals
- Manufacturers
- Supernus PharmaceuticalsAdamas Pharma
- 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
- N04BB01 Amantadine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 24 August 2017
- Identifiers
- RxCUI 1944370, 1944376, 1944380 +1DailyMed set ID 2bee0631-0028-1314-e063-6394a90aaaed, 82ff865f-78f3-4c94-b6a9-727a54944b28NDC 17772-085, 70482-085Application NDA208944
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 |
|---|---|---|---|
| 60 capsule, coated pellets in 1 bottle | 17772-085-60 | Supernus Pharmaceuticals | 24 August 2017 |
| 60 capsule, coated pellets in 1 bottle | 70482-085-60 | Adamas Pharma | 24 August 2017 |
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 14 February 1968 | 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 Amantadine
Clinical summary
Amantadine is an influenza A M2 protein inhibitor indicated for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy,, among other approved uses. It is available as capsules, oral solution and tablets. MedsAcross supplies Amantadine 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 AmantadineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- GOCOVRI prescribing information (Adamas Pharma) · U.S. National Library of Medicine, DailyMed
Need Gocovri 68.5 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.