Medicine
Donepezil 5 mg orally disintegrating tablet
Donepezil 5 mg orally disintegrating tablet is a generic prescription medicine for oral use, made by 2 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 o to 25 • C (68 o to 77 • F).
Key facts
- Active ingredient (INN)
- Donepezil
- Brand
- Sold under the generic name
- Strength
- 5 mg
- Dosage form
- Orally disintegrating tablet
- Route
- Oral
- Packs
- 3 blister pack, 30 tablets, 10 blister pack and 2 more
- Manufacturers
- Macleods PharmaceuticalsIndiaUnichem LaboratoriesIndia
- Origin register
- US FDA, United States
- Storage
- Store at 20 o to 25 • C (68 o to 77 • 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
- 14 December 2012
- Identifiers
- RxCUI 997220, 997223, 997226 +2DailyMed set ID 1a8906ce-96dc-4bc8-81c1-5db67a187aac, 06dd25a5-1bf2-446d-ad75-ff9d55117660NDC 29300-250, 33342-029Application ANDA204831, ANDA201787
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 |
|---|---|---|---|
| 3 blister pack in 1 carton / 10 tablet, orally disintegrating in 1 blister pack | 33342-029-06 | Macleods PharmaceuticalsIndia | 14 December 2012 |
| 30 tablet, orally disintegrating in 1 bottle | 33342-029-07 | Macleods PharmaceuticalsIndia | 14 December 2012 |
| 10 blister pack in 1 carton / 10 tablet, orally disintegrating in 1 blister pack | 33342-029-12 | Macleods PharmaceuticalsIndia | 14 December 2012 |
| 4 blister pack in 1 carton / 7 tablet, orally disintegrating in 1 blister pack | 33342-029-60 | Macleods PharmaceuticalsIndia | 14 December 2012 |
| 3 blister pack in 1 carton / 10 tablet, orally disintegrating in 1 blister pack | 29300-250-87 | Unichem LaboratoriesIndia | 28 February 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.
| 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
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 orally disintegrating 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.