Medicine
Amantadine 100 mg tablet
Amantadine 100 mg tablet is a generic prescription medicine for oral use, made by 9 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°C to 25°C (68°F to 77°F). Excursions permitted to 15°C to 30°C…
Key facts
- Active ingredient (INN)
- Amantadine
- Brand
- Sold under the generic name
- Strength
- 100 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 2 blister pack and 14 more
- Manufacturers
- Alembic PharmaceuticalsIndiaStrides PharmaIndiaCouplerDirect_RxMarlex PharmaceuticalsUpsher-Smith LaboratoriesProficient RxVangard LabsZhejiang Jutai Pharmaceutical
- 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
- 15 December 2011
- Identifiers
- RxCUI 849395, 849389DailyMed set ID 9a99bb98-82a4-4b9e-9216-554dade72a3c, 48fa07c8-8b95-40d7-a0f5-132577dfb2c8, da1837b5-fda2-48e0-91ba-d6eb2b991b55 +8NDC 42543-497, 46708-586, 62332-586 +8Application ANDA209035, ANDA214284, ANDA218598 +2
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 in 1 bottle | 46708-586-31 | Alembic PharmaceuticalsIndia | 20 October 2020 |
| 500 tablet in 1 bottle | 46708-586-71 | Alembic PharmaceuticalsIndia | 20 October 2020 |
| 100 tablet in 1 bottle | 62332-586-31 | Alembic PharmaceuticalsIndia | 20 October 2020 |
| 500 tablet in 1 bottle | 62332-586-71 | Alembic PharmaceuticalsIndia | 20 October 2020 |
| 100 tablet in 1 bottle | 42543-497-01 | Strides PharmaIndia | 4 August 2017 |
| 500 tablet in 1 bottle | 42543-497-05 | Strides PharmaIndia | 8 August 2017 |
| 100 tablet in 1 bottle | 0832-0111-00 | Upsher-Smith Laboratories | 15 December 2011 |
| 500 tablet in 1 bottle | 0832-0111-50 | Upsher-Smith Laboratories | 15 December 2011 |
| 2 blister pack in 1 box / 12 tablet in 1 blister pack | 71765-009-01 | Zhejiang Jutai Pharmaceutical | 26 September 2024 |
| 30 tablet in 1 blister pack | 67046-1452-3 | Coupler | 7 February 2025 |
| 30 tablet in 1 blister pack | 67046-1531-3 | Coupler | 13 March 2025 |
| 30 tablet in 1 bottle | 72189-535-30 | Direct_Rx | 23 February 2024 |
| 90 tablet in 1 bottle | 72189-535-90 | Direct_Rx | 23 February 2024 |
| 100 tablet in 1 bottle | 10135-692-01 | Marlex Pharmaceuticals | 1 March 2020 |
| 500 tablet in 1 bottle | 10135-692-05 | Marlex Pharmaceuticals | 1 March 2020 |
| 20 tablet in 1 bottle | 82804-267-20 | Proficient Rx | 18 February 2026 |
| 30 tablet in 1 blister pack | 0615-8605-39 | Vangard Labs | 20 January 2026 |
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 Amantadine 100 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.