Medicine
Donepezil 5 mg tablet
Donepezil 5 mg tablet is a generic prescription medicine for oral use, made by 23 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), excursions permitted to 15° to 30°C (59°…
Key facts
- Active ingredient (INN)
- Donepezil
- Brand
- Sold under the generic name
- Strength
- 5 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 30 tablets, 90 tablets and 82 more
- Manufacturers
- Alembic PharmaceuticalsIndiaAurobindo PharmaIndiaMacleods PharmaceuticalsIndiaCamber PharmaceuticalsIndiaTorrent PharmaceuticalsIndiaUnichem LaboratoriesIndiaCadila PharmaceuticalsIndiaSolco Healthcare23 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N06DA02 Donepezil
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 28 May 2011
- Identifiers
- RxCUI 997223, 997229, 997220 +2DailyMed set ID 6e9aacf9-abb6-4dec-9a8d-4eabf934d512, 9407258b-60ed-4884-a903-885aeedaddf8, c7e1f642-1bdc-4ed6-9b9e-c1af40b926cd +28NDC 50228-139, 62332-092, 82009-119 +28Application ANDA203907, ANDA201724, ANDA203034 +7
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 23 labelers. The register lists 85 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet, film coated in 1 carton | 46708-295-10 | Alembic PharmaceuticalsIndia | 29 January 2016 |
| 30 tablet, film coated in 1 bottle | 46708-295-30 | Alembic PharmaceuticalsIndia | 29 January 2016 |
| 90 tablet, film coated in 1 bottle | 46708-295-90 | Alembic PharmaceuticalsIndia | 29 January 2016 |
| 1000 tablet, film coated in 1 bottle | 46708-295-91 | Alembic PharmaceuticalsIndia | 29 January 2016 |
| 100 tablet, film coated in 1 carton | 62332-092-10 | Alembic PharmaceuticalsIndia | 29 January 2016 |
| 30 tablet, film coated in 1 bottle | 62332-092-30 | Alembic PharmaceuticalsIndia | 29 January 2016 |
| 90 tablet, film coated in 1 bottle | 62332-092-90 | Alembic PharmaceuticalsIndia | 29 January 2016 |
| 1000 tablet, film coated in 1 bottle | 62332-092-91 | Alembic PharmaceuticalsIndia | 29 January 2016 |
| 100 tablet, film coated in 1 bottle | 65862-325-01 | Aurobindo PharmaIndia | 31 May 2011 |
| 500 tablet, film coated in 1 bottle | 65862-325-05 | Aurobindo PharmaIndia | 31 May 2011 |
| 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 65862-325-10 | Aurobindo PharmaIndia | 31 May 2011 |
| 30 tablet, film coated in 1 bottle | 65862-325-30 | Aurobindo PharmaIndia | 31 May 2011 |
| 90 tablet, film coated in 1 bottle | 65862-325-90 | Aurobindo PharmaIndia | 31 May 2011 |
| 1000 tablet, film coated in 1 bottle | 65862-325-99 | Aurobindo PharmaIndia | 31 May 2011 |
| 30 tablet, film coated in 1 bottle | 71209-019-01 | Cadila PharmaceuticalsIndia | 24 November 2018 |
| 90 tablet, film coated in 1 bottle | 71209-019-04 | Cadila PharmaceuticalsIndia | 24 November 2018 |
| 1000 tablet, film coated in 1 bottle | 71209-019-11 | Cadila PharmaceuticalsIndia | 24 November 2018 |
| 100 tablet in 1 bottle | 31722-737-01 | Camber PharmaceuticalsIndia | 2 February 2015 |
| 500 tablet in 1 bottle | 31722-737-05 | Camber PharmaceuticalsIndia | 2 February 2015 |
| 30 tablet in 1 bottle | 31722-737-30 | Camber PharmaceuticalsIndia | 2 February 2015 |
| 100 tablet in 1 blister pack | 31722-737-31 | Camber PharmaceuticalsIndia | 2 February 2015 |
| 90 tablet in 1 bottle | 31722-737-90 | Camber PharmaceuticalsIndia | 2 February 2015 |
| 30 tablet, film coated in 1 bottle | 33342-027-07 | Macleods PharmaceuticalsIndia | 17 August 2012 |
| 90 tablet, film coated in 1 bottle | 33342-027-10 | Macleods PharmaceuticalsIndia | 17 August 2012 |
| 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 33342-027-12 | Macleods PharmaceuticalsIndia | 17 August 2012 |
| 500 tablet, film coated in 1 bottle | 33342-027-15 | Macleods PharmaceuticalsIndia | 6 November 2014 |
| 5 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 33342-027-31 | Macleods PharmaceuticalsIndia | 17 August 2012 |
| 1000 tablet, film coated in 1 bottle | 33342-027-44 | Macleods PharmaceuticalsIndia | 6 November 2014 |
| 500 tablet, film coated in 1 bottle | 13668-102-05 | Torrent PharmaceuticalsIndia | 31 May 2011 |
| 1000 tablet, film coated in 1 bottle | 13668-102-10 | Torrent PharmaceuticalsIndia | 31 May 2011 |
| 30 tablet, film coated in 1 bottle | 13668-102-30 | Torrent PharmaceuticalsIndia | 31 May 2011 |
| 4000 tablet, film coated in 1 bottle | 13668-102-40 | Torrent PharmaceuticalsIndia | 31 May 2011 |
| 90 tablet, film coated in 1 bottle | 13668-102-90 | Torrent PharmaceuticalsIndia | 31 May 2011 |
| 100 tablet, film coated in 1 bottle, plastic | 29300-248-01 | Unichem LaboratoriesIndia | 28 February 2018 |
| 1000 tablet, film coated in 1 bottle, plastic | 29300-248-10 | Unichem LaboratoriesIndia | 28 February 2018 |
| 30 tablet, film coated in 1 bottle, plastic | 29300-248-13 | Unichem LaboratoriesIndia | 28 February 2018 |
| 90 tablet, film coated in 1 bottle, plastic | 29300-248-19 | Unichem LaboratoriesIndia | 28 February 2018 |
| 30 tablet, film coated in 1 bottle, plastic | 43547-275-03 | Solco Healthcare | 1 November 2011 |
| 90 tablet, film coated in 1 bottle, plastic | 43547-275-09 | Solco Healthcare | 1 November 2011 |
| 1000 tablet, film coated in 1 bottle, plastic | 43547-275-11 | Solco Healthcare | 1 November 2011 |
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 25 November 1996 | 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
Alternatives
Other makers and brands of Donepezil 5 mg tablet.
Other strengths and forms of Donepezil
Clinical summary
Donepezil is a cholinesterase inhibitor indicated for the treatment of dementia of the Alzheimer’s type. It is available as tablets and orally disintegrating tablets. MedsAcross supplies Donepezil 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 DonepezilFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Aricept prescribing information (Eisai) · U.S. National Library of Medicine, DailyMed
Need Donepezil 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.