Medicine
Amantadine 50 mg/5 mL oral solution
Amantadine 50 mg/5 mL oral solution is a generic prescription medicine for oral use, made by 10 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). *Dyazide is a registered trademark of…
Key facts
- Active ingredient (INN)
- Amantadine
- Brand
- Sold under the generic name
- Strength
- 50 mg/5 mL
- Dosage form
- Oral solution
- Route
- Oral
- Packs
- 473 mL, 2 trays, 10 trays and 12 more
- Manufacturers
- Atlantic BiologicalsChartwell RXPAI PharmaPatrin PharmaXttrium LaboratoriesAmerican Health PackagingAvPAKBajaj MedicalCardinal HealthChartwell Governmental & Specialty RX
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F). *Dyazide is a registered trademark of GlaxoSmithKline.
- 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
- 28 June 1993
- Identifiers
- RxCUI 849385DailyMed set ID 5a8f16cc-e5d5-4097-8297-10c8166c7a0e, 52aa093c-82cc-4d81-b072-86a2b8adc9c5, 48c949e3-86e0-c639-e063-6294a90acdba +7NDC 60687-797, 62135-011, 50268-036 +8Application ANDA074509, ANDA074028, ANDA075060 +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 |
|---|---|---|---|
| 473 mL in 1 bottle | 62135-010-47 | Chartwell RX | 13 December 2022 |
| 2 tray in 1 box / 10 cup, unit-dose in 1 tray / 10 mL in 1 cup, unit-dose | 62135-011-24 | Chartwell RX | 28 June 1993 |
| 473 mL in 1 bottle | 61037-484-03 | Bajaj Medical | 31 July 2025 |
| 2 tray in 1 box / 10 cup, unit-dose in 1 tray / 10 mL in 1 cup, unit-dose | 68999-011-24 | Chartwell Governmental & Specialty RX | 17 December 2025 |
| 10 tray in 1 case / 10 cup, unit-dose in 1 tray / 10 mL in 1 cup, unit-dose | 0121-0646-10 | PAI Pharma | 17 July 1995 |
| 473 mL in 1 bottle | 0121-0646-16 | PAI Pharma | 17 July 1995 |
| 473 mL in 1 bottle, plastic | 39328-530-16 | Patrin Pharma | 11 August 2023 |
| 10 tray in 1 case / 10 cup, unit-dose in 1 tray / 10 mL in 1 cup, unit-dose | 39328-530-99 | Patrin Pharma | 8 May 2024 |
| 473 mL in 1 bottle | 0116-4010-16 | Xttrium Laboratories | 5 November 2024 |
| 100 tray in 1 case / 10 cup, unit-dose in 1 tray / 10 mL in 1 cup, unit-dose | 0116-4010-41 | Xttrium Laboratories | 5 November 2024 |
| 10 tray in 1 case / 10 cup, unit-dose in 1 tray / 10 mL in 1 cup, unit-dose | 60687-797-56 | American Health Packaging | 26 February 2024 |
| 72 cup, unit-dose in 1 box, unit-dose / 10 mL in 1 cup, unit-dose | 17856-0646-1 | Atlantic Biologicals | 8 April 2024 |
| 72 cup, unit-dose in 1 package / 5 mL in 1 cup, unit-dose | 17856-0646-2 | Atlantic Biologicals | 8 April 2024 |
| 40 tray in 1 case / 10 cup, unit-dose in 1 tray / 10 mL in 1 cup, unit-dose | 50268-036-14 | AvPAK | 19 January 2026 |
| 5 cup, unit-dose in 1 bag / 10 mL in 1 cup, unit-dose | 55154-9444-5 | Cardinal Health | 17 July 1995 |
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 50 mg/5 mL oral solution 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.