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Medicine

Amantadine 100 mg capsule

Amantadine · Oral
Available on requestPrescription onlyUS FDAGeneric name

Amantadine 100 mg capsule is a generic prescription medicine for oral use, made by 22 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

Available on request

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).

Key facts

Active ingredient (INN)
Amantadine
Brand
Sold under the generic name
Strength
100 mg
Dosage form
Capsule
Route
Oral
Packs
30 capsules, 100 capsules, 500 capsules and 87 more
Manufacturers
Alembic PharmaceuticalsIndiaZydus LifesciencesIndiaStrides PharmaIndiaAvet PharmaceuticalsIndiaAdvagen PharmaBryant Ranch PrepackBionpharmaEpic PharmaRising Pharma HoldingsUpsher-Smith Laboratories22 labelers on the register
Origin register
US FDA, United States
Storage
Store at 20° to 25°C (68° to 77°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
18 February 1987
Identifiers
RxCUI 849389, 849395DailyMed set ID c3b9e7f0-be6d-4f37-9277-54bb0ba8b158, b2f7da34-ad78-4db3-9af1-bdd341e09f16, d8887814-3e56-447e-8bc3-add1861e0cf7 +32NDC 72888-033, 0904-7042, 46708-246 +32Application ANDA212044, ANDA209171, ANDA208966 +8

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

A sample of 40 packs from 22 labelers. The register lists 90 packs for this generic presentation, and we confirm the exact pack on the quote.

PackCodeLabelerMarketed since
30 capsule in 1 bottle46708-246-30Alembic PharmaceuticalsIndia22 June 2017
100 capsule in 1 bottle46708-246-31Alembic PharmaceuticalsIndia22 June 2017
500 capsule in 1 bottle46708-246-71Alembic PharmaceuticalsIndia22 June 2017
1000 capsule in 1 bottle46708-246-91Alembic PharmaceuticalsIndia22 June 2017
30 capsule in 1 bottle62332-246-30Alembic PharmaceuticalsIndia22 June 2017
100 capsule in 1 bottle62332-246-31Alembic PharmaceuticalsIndia22 June 2017
500 capsule in 1 bottle62332-246-71Alembic PharmaceuticalsIndia22 June 2017
1000 capsule in 1 bottle62332-246-91Alembic PharmaceuticalsIndia22 June 2017
100 capsule in 1 bottle42543-493-01Strides PharmaIndia31 July 2017
500 capsule in 1 bottle42543-493-05Strides PharmaIndia31 July 2017
100 capsule, liquid filled in 1 bottle64380-862-06Strides PharmaIndia1 December 2022
500 capsule, liquid filled in 1 bottle64380-862-07Strides PharmaIndia1 December 2022
100 capsule in 1 bottle65841-835-01Zydus LifesciencesIndia4 August 2016
500 capsule in 1 bottle65841-835-05Zydus LifesciencesIndia4 August 2016
30 capsule in 1 bottle65841-835-06Zydus LifesciencesIndia4 August 2016
10 blister pack in 1 carton / 10 capsule in 1 blister pack65841-835-77Zydus LifesciencesIndia4 August 2016
100 capsule in 1 bottle68382-512-01Zydus LifesciencesIndia4 August 2016
500 capsule in 1 bottle68382-512-05Zydus LifesciencesIndia4 August 2016
30 capsule in 1 bottle68382-512-06Zydus LifesciencesIndia4 August 2016
10 blister pack in 1 carton / 10 capsule in 1 blister pack68382-512-77Zydus LifesciencesIndia4 August 2016
100 capsule in 1 bottle23155-362-01Avet PharmaceuticalsIndia12 June 2017
30 capsule in 1 bottle23155-362-03Avet PharmaceuticalsIndia12 June 2017
500 capsule in 1 bottle23155-362-05Avet PharmaceuticalsIndia12 June 2017
1000 capsule in 1 bottle72888-033-00Advagen Pharma21 May 2020
100 capsule in 1 bottle72888-033-01Advagen Pharma21 May 2020
500 capsule in 1 bottle72888-033-05Advagen Pharma21 May 2020
30 capsule in 1 bottle72888-033-30Advagen Pharma21 May 2020
100 capsule, liquid filled in 1 bottle69452-142-20Bionpharma15 August 2016
500 capsule, liquid filled in 1 bottle69452-142-30Bionpharma15 August 2016
90 capsule in 1 bottle62135-609-90Chartwell RX29 June 2023
500 capsule in 1 bottle42806-716-05Epic Pharma17 June 2021
10 capsule in 1 bottle42806-716-11Epic Pharma17 June 2021
100 capsule in 1 bottle16571-834-01Rising Pharma Holdings5 September 2022
500 capsule in 1 bottle16571-834-50Rising Pharma Holdings5 September 2022
100 capsule, gelatin coated in 1 bottle0832-1015-00Upsher-Smith Laboratories15 September 2011
500 capsule, gelatin coated in 1 bottle0832-1015-50Upsher-Smith Laboratories15 September 2011
20 capsule in 1 bottle71335-0469-1Bryant Ranch Prepack27 December 2021
30 capsule in 1 bottle71335-0469-2Bryant Ranch Prepack30 August 2021
10 capsule in 1 bottle71335-0469-3Bryant Ranch Prepack27 December 2021
14 capsule in 1 bottle71335-0469-4Bryant Ranch Prepack22 October 2018

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.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 14 February 1968Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS 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 Amantadine

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Amantadine 100 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.