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Last Updated: December 30, 2025

Details for New Drug Application (NDA): 205269

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NDA 205269 describes DONEPEZIL HYDROCHLORIDE, which is a drug marketed by Aiping Pharm Inc, Chartwell Rx, Hisun Pharm Hangzhou, Macleods Pharms Ltd, Sun Pharm Industries, Unichem, Zydus Pharms Usa Inc, Accord Hlthcare, Actavis Elizabeth, Alembic Pharms Ltd, Apotex, Aurobindo, Cadila Pharms Ltd, Cipla Ltd, Dexcel, Dr Reddys, Dr Reddys Labs Ltd, Heritage Pharma, Hetero Labs Ltd V, Hikma Pharms, Indicus Pharma, Jubilant Generics, Lupin Ltd, Natco Pharma, Novitium Pharma, Osmotica Pharm Us, Ph Health, Prinston Inc, Rising, Sciegen Pharms Inc, Strides Pharma, Sun Pharm, Sun Pharm Inds, Sun Pharm Inds Ltd, Torrent Pharms, Twi Pharms, Wockhardt, Zydus Lifesciences, and Zydus Pharms, and is included in forty-seven NDAs. It is available from thirty-four suppliers. Additional details are available on the DONEPEZIL HYDROCHLORIDE profile page.

The generic ingredient in DONEPEZIL HYDROCHLORIDE is donepezil hydrochloride. There are thirty-two drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the donepezil hydrochloride profile page.

Summary for 205269

Tradename:	DONEPEZIL HYDROCHLORIDE
Applicant:	Hisun Pharm Hangzhou
Ingredient:	donepezil hydrochloride
Patents:	0

Pharmacology for NDA: 205269

Mechanism of Action	Cholinesterase Inhibitors

Suppliers and Packaging for NDA: 205269

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	205269	ANDA	Hisun Pharmaceuticals USA, Inc.	42658-119	42658-119-01	30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (42658-119-01)
DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	205269	ANDA	Hisun Pharmaceuticals USA, Inc.	42658-119	42658-119-04	90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (42658-119-04)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	5MG
Approval Date:	Jul 27, 2018	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	10MG
Approval Date:	Jul 27, 2018	TE:	AB	RLD:	No

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