Medicine
Donepezil 23 mg tablet
Donepezil 23 mg tablet is a generic prescription medicine for oral use, made by 9 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 20º - 25ºC (68º - 77ºF), excursions permitted to 15º - 30ºC (59º -…
Key facts
- Active ingredient (INN)
- Donepezil
- Brand
- Sold under the generic name
- Strength
- 23 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 30 tablets, 90 tablets, 10 blister pack and 19 more
- Manufacturers
- Macleods PharmaceuticalsIndiaSun Pharmaceutical IndustriesIndiaDr. Reddy's LaboratoriesIndiaLupinIndiaProficient RxBryant Ranch PrepackEdenbridge PharmaceuticalsUpsher-Smith LaboratoriesGolden State Medical Supply
- Origin register
- US FDA, United States
- Storage
- Store at 20º - 25ºC (68º - 77ºF), excursions permitted to 15º - 30ºC (59º - 86ºF).
- 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
- 23 January 2014
- Identifiers
- RxCUI 1100184, 997223, 997229 +2DailyMed set ID 11404dc3-1bde-4d4e-8386-006b67ee19dd, 7c0d3bcb-157d-0414-64ee-055bc614d190, 12a755c5-1ad9-43d1-832a-eb2ff17bd693 +7NDC 42799-954, 55111-302, 24979-004 +7Application ANDA203713, ANDA202723, ANDA203104 +3
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 |
|---|---|---|---|
| 30 tablet, film coated in 1 bottle | 55111-302-30 | Dr. Reddy's LaboratoriesIndia | 20 August 2025 |
| 90 tablet, film coated in 1 bottle | 55111-302-90 | Dr. Reddy's LaboratoriesIndia | 20 August 2025 |
| 30 tablet in 1 bottle | 68180-527-06 | LupinIndia | 21 December 2015 |
| 90 tablet in 1 bottle | 68180-527-09 | LupinIndia | 21 December 2015 |
| 30 tablet, film coated in 1 bottle | 33342-061-07 | Macleods PharmaceuticalsIndia | 23 January 2014 |
| 90 tablet, film coated in 1 bottle | 33342-061-10 | Macleods PharmaceuticalsIndia | 23 January 2014 |
| 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 33342-061-12 | Macleods PharmaceuticalsIndia | 23 January 2014 |
| 1000 tablet, film coated in 1 bottle | 62756-194-18 | Sun Pharmaceutical IndustriesIndia | 17 June 2015 |
| 90 tablet, film coated in 1 bottle | 62756-194-81 | Sun Pharmaceutical IndustriesIndia | 17 June 2015 |
| 30 tablet, film coated in 1 bottle | 62756-194-83 | Sun Pharmaceutical IndustriesIndia | 17 June 2015 |
| 30 tablet, film coated in 1 bottle | 42799-954-01 | Edenbridge Pharmaceuticals | 5 December 2023 |
| 90 tablet, film coated in 1 bottle | 42799-954-02 | Edenbridge Pharmaceuticals | 5 December 2023 |
| 30 tablet, film coated in 1 bottle | 24979-004-06 | Upsher-Smith Laboratories | 1 March 2015 |
| 90 tablet, film coated in 1 bottle | 24979-004-07 | Upsher-Smith Laboratories | 22 September 2015 |
| 30 tablet, film coated in 1 bottle | 63629-8483-1 | Bryant Ranch Prepack | 18 May 2021 |
| 30 tablet, film coated in 1 bottle | 72162-1276-3 | Bryant Ranch Prepack | 5 February 2024 |
| 30 tablet, film coated in 1 bottle | 51407-320-30 | Golden State Medical Supply | 24 January 2020 |
| 100 tablet, film coated in 1 bottle | 71205-948-00 | Proficient Rx | 19 November 2020 |
| 30 tablet, film coated in 1 bottle | 71205-948-30 | Proficient Rx | 19 November 2020 |
| 500 tablet, film coated in 1 bottle | 71205-948-55 | Proficient Rx | 19 November 2020 |
| 60 tablet, film coated in 1 bottle | 71205-948-60 | Proficient Rx | 19 November 2020 |
| 90 tablet, film coated in 1 bottle | 71205-948-90 | Proficient Rx | 19 November 2020 |
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 23 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 23 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.