FDA — authorised 18 October 2004
- Application: NDA021720
- Marketing authorisation holder: EISAI INC
- Local brand name: ARICEPT ODT
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
🇺🇸 DONEPEZIL HYDROCHLORIDE in United States
FDA authorised DONEPEZIL HYDROCHLORIDE on 18 October 2004 · 2,683 US adverse-event reports
Marketing authorisations
FDA — authorised 11 December 2009
- Application: ANDA077975
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: DONEPEZIL HYDROCHLORIDE
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 29 June 2010
- Application: ANDA077344
- Marketing authorisation holder: HERITAGE PHARMA
- Local brand name: DONEPEZIL HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 November 2010
- Application: ANDA076786
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: DONEPEZIL HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 May 2011
- Application: ANDA090175
- Marketing authorisation holder: ZYDUS PHARMS USA INC
- Local brand name: DONEPEZIL HYDROCHLORIDE
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 10 May 2011
- Application: ANDA091198
- Marketing authorisation holder: AIPING PHARM INC
- Local brand name: DONEPEZIL HYDROCHLORIDE
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 31 May 2011
- Application: ANDA090290
- Marketing authorisation holder: AIPING PHARM INC
- Local brand name: DONEPEZIL HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 May 2011
- Application: ANDA090686
- Marketing authorisation holder: TORRENT PHARMS
- Status: approved
FDA — authorised 31 May 2011
- Application: ANDA090425
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: DONEPEZIL HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 May 2011
- Application: ANDA090768
- Marketing authorisation holder: JUBILANT GENERICS
- Local brand name: DONEPEZIL HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 May 2011
- Application: ANDA090493
- Marketing authorisation holder: SUN PHARM INDS
- Local brand name: DONEPEZIL HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 May 2011
- Application: ANDA090521
- Marketing authorisation holder: NATCO PHARMA
- Local brand name: DONEPEZIL HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 May 2011
- Application: ANDA090551
- Marketing authorisation holder: NOVITIUM PHARMA
- Local brand name: DONEPEZIL HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 May 2011
- Application: ANDA090247
- Marketing authorisation holder: HIKMA PHARMS
- Local brand name: DONEPEZIL HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 May 2011
- Application: ANDA201001
- Marketing authorisation holder: DR REDDYS LABS LTD
- Local brand name: DONEPEZIL HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 May 2011
- Application: ANDA091267
- Marketing authorisation holder: WOCKHARDT
- Local brand name: DONEPEZIL HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 May 2011
- Application: ANDA078662
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: DONEPEZIL HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 May 2011
- Application: ANDA200292
- Marketing authorisation holder: PRINSTON INC
- Indication: Labeling
- Status: approved
FDA — authorised 2 June 2011
- Application: ANDA078841
- Marketing authorisation holder: APOTEX
- Local brand name: DONEPEZIL HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 June 2011
- Application: ANDA201634
- Marketing authorisation holder: INDICUS PHARMA
- Local brand name: DONEPEZIL HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 August 2012
- Application: ANDA201146
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Indication: Not Applicable
- Status: approved
FDA — authorised 24 October 2012
- Application: ANDA090100
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Local brand name: DONEPEZIL HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 December 2012
- Application: ANDA201787
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: DONEPEZIL HYDROCHLORIDE
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 25 February 2013
- Application: ANDA201724
- Marketing authorisation holder: ALEMBIC PHARMS LTD
- Local brand name: DONEPEZIL HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 July 2013
- Application: ANDA202114
- Marketing authorisation holder: RISING
- Local brand name: DONEPEZIL HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 July 2013
- Application: ANDA202542
- Marketing authorisation holder: PH HEALTH
- Local brand name: DONEPEZIL HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 July 2013
- Application: ANDA202723
- Marketing authorisation holder: DR REDDYS
- Status: supplemented
FDA — authorised 22 January 2014
- Application: ANDA202631
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: DONEPEZIL HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 December 2014
- Application: NDA206439
- Marketing authorisation holder: ABBVIE
- Local brand name: NAMZARIC
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 19 February 2016
- Application: ANDA203713
- Marketing authorisation holder: DEXCEL
- Local brand name: DONEPEZIL HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 June 2016
- Application: ANDA203656
- Marketing authorisation holder: UNICHEM
- Local brand name: DONEPEZIL HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 November 2016
- Application: ANDA204831
- Marketing authorisation holder: UNICHEM
- Local brand name: DONEPEZIL HYDROCHLORIDE
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 27 January 2017
- Application: ANDA208328
- Marketing authorisation holder: AMNEAL
- Local brand name: MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 31 August 2017
- Application: ANDA203162
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: DONEPEZIL HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 September 2017
- Application: ANDA204609
- Marketing authorisation holder: CADILA PHARMS LTD
- Status: supplemented
FDA — authorised 27 July 2018
- Application: ANDA205269
- Marketing authorisation holder: HISUN PHARM HANGZHOU
- Local brand name: DONEPEZIL HYDROCHLORIDE
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 15 July 2025
- Application: ANDA216901
- Marketing authorisation holder: XIAMEN LP PHARM CO
- Local brand name: MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 15 July 2025
- Application: ANDA208672
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 2,683
Most-reported reactions
- Fall — 434 reports (16.18%)
- Diarrhoea — 299 reports (11.14%)
- Dizziness — 281 reports (10.47%)
- Fatigue — 280 reports (10.44%)
- Drug Interaction — 268 reports (9.99%)
- Death — 242 reports (9.02%)
- Nausea — 241 reports (8.98%)
- Confusional State — 222 reports (8.27%)
- Vomiting — 211 reports (7.86%)
- Asthenia — 205 reports (7.64%)
DONEPEZIL HYDROCHLORIDE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is DONEPEZIL HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 18 October 2004; FDA authorised it on 11 December 2009; FDA authorised it on 29 June 2010.
Who is the marketing authorisation holder for DONEPEZIL HYDROCHLORIDE in United States?
EISAI INC holds the US marketing authorisation.