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Medicine

Rivastigmine 4.5 mg capsule

Rivastigmine · Oral
Available on requestPrescription onlyUS FDAGeneric name

Rivastigmine 4.5 mg capsule is a generic prescription medicine for oral use, made by 8 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), excursions permitted between 15° and 30°C…

Key facts

Active ingredient (INN)
Rivastigmine
Brand
Sold under the generic name
Strength
4.5 mg
Dosage form
Capsule
Route
Oral
Packs
100 blister pack, 30 capsules, 60 capsules and 26 more
Manufacturers
Alembic PharmaceuticalsIndiaDr. Reddy's LaboratoriesIndiaMacleods PharmaceuticalsIndiaAurobindo PharmaIndiaSun Pharmaceutical IndustriesIndiaCadila PharmaceuticalsIndiaModavar PharmaceuticalsChartwell RX
Origin register
US FDA, United States
Storage
Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° and 30°C (59° and 86°F).
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
N06DA03 Rivastigmine
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
1 July 2010
Identifiers
RxCUI 312835, 312836, 314214 +1DailyMed set ID bac9ca81-db70-41aa-82af-6c5bb8496846, e7e641fe-39bd-4681-a430-6dedeb6d6af5, 0e20124c-725a-0145-996c-2ff908703162 +6NDC 62756-147, 71209-014, 55111-354 +6Application ANDA077131, ANDA203844, ANDA077130 +4

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.

PackCodeLabelerMarketed since
100 blister pack in 1 box, unit-dose / 10 capsule in 1 blister pack46708-065-10Alembic PharmaceuticalsIndia13 June 2012
30 capsule in 1 bottle46708-065-30Alembic PharmaceuticalsIndia13 June 2012
60 capsule in 1 bottle46708-065-60Alembic PharmaceuticalsIndia13 June 2012
500 capsule in 1 bottle46708-065-71Alembic PharmaceuticalsIndia13 June 2012
1000 capsule in 1 bottle46708-065-91Alembic PharmaceuticalsIndia13 June 2012
100 blister pack in 1 box, unit-dose / 10 capsule in 1 blister pack62332-065-10Alembic PharmaceuticalsIndia12 June 2022
30 capsule in 1 bottle62332-065-30Alembic PharmaceuticalsIndia12 June 2022
60 capsule in 1 bottle62332-065-60Alembic PharmaceuticalsIndia12 June 2022
500 capsule in 1 bottle62332-065-71Alembic PharmaceuticalsIndia12 June 2022
1000 capsule in 1 bottle62332-065-91Alembic PharmaceuticalsIndia12 June 2022
500 capsule in 1 bottle65862-650-05Aurobindo PharmaIndia25 March 2016
60 capsule in 1 bottle65862-650-60Aurobindo PharmaIndia25 March 2016
10 blister pack in 1 carton / 10 capsule in 1 blister pack65862-650-78Aurobindo PharmaIndia25 March 2016
60 capsule in 1 bottle71209-014-03Cadila PharmaceuticalsIndia11 February 2014
500 capsule in 1 bottle71209-014-10Cadila PharmaceuticalsIndia11 February 2014
100 capsule in 1 bottle55111-354-01Dr. Reddy's LaboratoriesIndia1 September 2011
500 capsule in 1 bottle55111-354-05Dr. Reddy's LaboratoriesIndia1 September 2011
30 capsule in 1 bottle55111-354-30Dr. Reddy's LaboratoriesIndia1 September 2011
60 capsule in 1 bottle55111-354-60Dr. Reddy's LaboratoriesIndia1 September 2011
3 blister pack in 1 box, unit-dose / 10 capsule in 1 blister pack33342-091-06Macleods PharmaceuticalsIndia2 September 2014
60 capsule in 1 bottle33342-091-09Macleods PharmaceuticalsIndia2 September 2014
10 blister pack in 1 box, unit-dose / 10 capsule in 1 blister pack33342-091-12Macleods PharmaceuticalsIndia2 September 2014
500 capsule in 1 bottle33342-091-15Macleods PharmaceuticalsIndia2 September 2014
500 capsule in 1 bottle62756-147-13Sun Pharmaceutical IndustriesIndia1 July 2010
100 blister pack in 1 box, unit-dose / 1 capsule in 1 blister pack62756-147-61Sun Pharmaceutical IndustriesIndia1 July 2010
60 capsule in 1 bottle62756-147-86Sun Pharmaceutical IndustriesIndia1 July 2010
60 capsule in 1 bottle62135-902-60Chartwell RX4 January 2023
60 capsule in 1 bottle72241-013-03Modavar Pharmaceuticals5 October 2021
500 capsule in 1 bottle72241-013-10Modavar Pharmaceuticals5 October 2021

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 21 April 2000Drugs@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 Rivastigmine

Clinical summary

Rivastigmine is a cholinesterase inhibitor indicated for treatment of mild, moderate, and severe dementia of the Alzheimer’s type (AD), among other approved uses. It is available as capsules and transdermal patches for oral use. MedsAcross supplies Rivastigmine 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 Rivastigmine

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

Data sources

Need Rivastigmine 4.5 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.