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Active ingredient

Donepezil

73 finished FDA listings contain Donepezil as their only active ingredient; 14 combination products also contain it.

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FDA NDC Directory

Ingredient names as written by FDA
DONEPEZIL, DONEPEZIL HYDROCHLORIDE
Dosage forms
Tablet, Tablet, Film Coated, Tablet, Orally Disintegrating
Routes
Oral
Manufacturers / labelers
32
Strengths listed
10 mg/1 · 23 mg/1 · 5 mg/1
Brand names in FDA listings
Aricept, Donepezil

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 135447

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 020690EISAI INC1996-11-252
NDA 022568EISAI INC2010-07-231
ANDA 200292PRINSTON INC2011-05-3111
ANDA 090056AUROBINDO2011-05-3111
ANDA 090686TORRENT PHARMS2011-05-316
ANDA 078662STRIDES PHARMA2011-05-311
ANDA 201146MACLEODS PHARMS LTD2012-08-177
ANDA 201787MACLEODS PHARMS LTD2012-12-142
ANDA 201724ALEMBIC PHARMS LTD2013-02-254
ANDA 202723DR REDDYS2013-07-241
ANDA 202631MACLEODS PHARMS2014-01-221
ANDA 203907SCIEGEN PHARMS2014-10-294
ANDA 203104TWI PHARMS2014-10-295
ANDA 203034HETERO LABS LTD V2015-01-308
ANDA 204293SUN PHARM2015-06-051
ANDA 202782LUPIN2015-10-301
ANDA 203713DEXCEL2016-02-191
ANDA 203656UNICHEM2016-06-232
ANDA 204831UNICHEM2016-11-102
ANDA 204609CADILA PHARMS LTD2017-09-192

Official labeling on DailyMed

Showing the 12 most recent of 47 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.