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Medicine

Memantine 5 mg tablet

Memantine · Oral
Available on requestPrescription onlyUS FDAGeneric name

Memantine 5 mg tablet is a generic prescription medicine for oral use, made by 29 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°C to 25°C (68°F to 77°F).

Key facts

Active ingredient (INN)
Memantine
Brand
Sold under the generic name
Strength
5 mg
Dosage form
Tablet
Route
Oral
Packs
100 tablets, 20 tablets, 30 tablets and 87 more
Manufacturers
Alembic PharmaceuticalsIndiaDr. Reddy's LaboratoriesIndiaAurobindo PharmaIndiaSun Pharmaceutical IndustriesIndiaCamber PharmaceuticalsIndiaMacleods PharmaceuticalsIndiaAjanta PharmaIndiaUnichem LaboratoriesIndiaLupinIndiaViona PharmaceuticalsIndia29 labelers on the register
Origin register
US FDA, United States
Storage
Store at 20°C to 25°C (68°F to 77°F).
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
N06DX01 Memantine
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
1 April 2015
Identifiers
RxCUI 996561, 996571, 996572DailyMed set ID dcbdb62a-a4e2-4058-b73c-46005f2a5d51, 72973b46-f307-4a9e-8fb1-ad2cbccfd736, d1963395-3cf7-4433-bf2c-06295bb1c5b0 +35NDC 72578-003, 0591-3870, 47335-321 +35Application ANDA090961, NDA021487, ANDA090058 +12

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 29 labelers. The register lists 90 packs for this generic presentation, and we confirm the exact pack on the quote.

PackCodeLabelerMarketed since
100 tablet, coated in 1 carton46708-451-10Alembic PharmaceuticalsIndia13 October 2015
20 tablet, coated in 1 bottle46708-451-20Alembic PharmaceuticalsIndia13 October 2015
30 tablet, coated in 1 bottle46708-451-30Alembic PharmaceuticalsIndia13 October 2015
100 tablet, coated in 1 bottle46708-451-31Alembic PharmaceuticalsIndia13 October 2015
3000 tablet, coated in 1 bottle46708-451-42Alembic PharmaceuticalsIndia13 October 2015
60 tablet, coated in 1 bottle46708-451-60Alembic PharmaceuticalsIndia13 October 2015
1000 tablet, coated in 1 bottle46708-451-91Alembic PharmaceuticalsIndia13 October 2015
100 tablet, coated in 1 carton62332-075-10Alembic PharmaceuticalsIndia13 October 2015
20 tablet, coated in 1 bottle62332-075-20Alembic PharmaceuticalsIndia13 October 2015
30 tablet, coated in 1 bottle62332-075-30Alembic PharmaceuticalsIndia13 October 2015
100 tablet, coated in 1 bottle62332-075-31Alembic PharmaceuticalsIndia13 October 2015
3000 tablet, coated in 1 bottle62332-075-42Alembic PharmaceuticalsIndia13 October 2015
60 tablet, coated in 1 bottle62332-075-60Alembic PharmaceuticalsIndia13 October 2015
1000 tablet, coated in 1 bottle62332-075-91Alembic PharmaceuticalsIndia13 October 2015
500 tablet in 1 bottle27241-070-05Ajanta PharmaIndia27 August 2015
60 tablet in 1 bottle27241-070-06Ajanta PharmaIndia27 August 2015
3 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack65862-652-03Aurobindo PharmaIndia13 October 2015
60 tablet, film coated in 1 bottle65862-652-60Aurobindo PharmaIndia13 October 2015
10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack65862-652-78Aurobindo PharmaIndia13 October 2015
1000 tablet, film coated in 1 bottle65862-652-99Aurobindo PharmaIndia13 October 2015
200 tablet in 1 bottle31722-807-02Camber PharmaceuticalsIndia26 September 2022
10 blister pack in 1 carton / 10 tablet in 1 blister pack31722-807-32Camber PharmaceuticalsIndia26 September 2022
60 tablet in 1 bottle31722-807-60Camber PharmaceuticalsIndia26 September 2022
100 tablet, film coated in 1 bottle55111-596-01Dr. Reddy's LaboratoriesIndia11 July 2015
500 tablet, film coated in 1 bottle55111-596-05Dr. Reddy's LaboratoriesIndia11 July 2015
30 tablet, film coated in 1 bottle55111-596-30Dr. Reddy's LaboratoriesIndia11 July 2015
60 tablet, film coated in 1 bottle55111-596-60Dr. Reddy's LaboratoriesIndia11 July 2015
10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack55111-596-78Dr. Reddy's LaboratoriesIndia11 July 2015
1 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack55111-596-79Dr. Reddy's LaboratoriesIndia11 July 2015
60 tablet, film coated in 1 bottle68180-229-07LupinIndia13 July 2015
60 tablet in 1 bottle33342-297-09Macleods PharmaceuticalsIndia13 October 2015
10 blister pack in 1 carton / 10 tablet in 1 blister pack33342-297-12Macleods PharmaceuticalsIndia13 October 2015
500 tablet in 1 bottle33342-297-15Macleods PharmaceuticalsIndia13 October 2015
100 tablet, film coated in 1 bottle47335-321-08Sun Pharmaceutical IndustriesIndia11 July 2015
1000 tablet, film coated in 1 bottle47335-321-18Sun Pharmaceutical IndustriesIndia11 July 2015
60 tablet, film coated in 1 bottle47335-321-86Sun Pharmaceutical IndustriesIndia11 July 2015
100 tablet, film coated in 1 bottle47335-321-88Sun Pharmaceutical IndustriesIndia11 July 2015
500 tablet, film coated in 1 bottle, plastic29300-171-05Unichem LaboratoriesIndia1 November 2015
60 tablet, film coated in 1 bottle, plastic29300-171-16Unichem LaboratoriesIndia1 November 2015
100 tablet in 1 bottle72578-003-01Viona PharmaceuticalsIndia28 February 2019

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 16 October 2003Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
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 Memantine

Clinical summary

Memantine is a N-methyl-D-aspartate receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer’s type. It is available as tablets, extended-release capsules and oral solution. MedsAcross supplies Memantine 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 Memantine

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

Data sources

Need Memantine 5 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.