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Donepezil Hydrochloride

Prescription ANDA TE AB
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Donepezil Hydrochloride
Generic name
Donepezil Hydrochloride
Dosage form
Tablet, Orally Disintegrating
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Macleods Pharmaceuticals Limited
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
4
Packages
10
Data completeness
54% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Donepezil Hydrochloride 10 mg/1 997223 View
Donepezil Hydrochloride 5 mg/1 997223 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Orally Disintegrating
Route of administration
Oral
Presentations
14

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Cholinesterase Inhibitor [EPC] EPC All 24 members
Cholinesterase Inhibitors [MoA] MoA All 24 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
201787
Application type
ANDA · Abbreviated New Drug Application
Approval date
December 14, 2012
Sponsor
MACLEODS PHARMS LTD
Products on application
2
Submissions recorded
5
Products approved under application 201787.
Product Trade name Form Strength Ingredient Status TE Flags
201787-001 DONEPEZIL HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING DONEPEZIL HYDROCHLORIDE Prescription AB
201787-002 DONEPEZIL HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING DONEPEZIL HYDROCHLORIDE Prescription AB RS

Therapeutic equivalence

Source: Orange Book
TE code
AB
Reference Listed Drug
No
Reference Standard
Yes

What this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA
Most recent submissions on application 201787.
Type No. Action Status Date Review
Supplement 16 Labeling Approved June 7, 2023 Standard
Supplement 10 Labeling Approved November 13, 2020 Standard
Supplement 3 Labeling Approved November 8, 2016 Standard
Supplement 2 Manufacturing (CMC) Approved April 23, 2015 Unknown
Original application 1 Approved December 14, 2012 —

Adverse event reports

Source: openFDA FAERS
37,021
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: DONEPEZIL HYDROCHLORIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
33342-029-06 33342-029 Macleods Pharmaceuticals Limited 3 BLISTER PACK in 1 CARTON (33342-029-06) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK December 14, 2012
33342-029-07 33342-029 Macleods Pharmaceuticals Limited 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (33342-029-07) December 14, 2012
33342-029-12 33342-029 Macleods Pharmaceuticals Limited 10 BLISTER PACK in 1 CARTON (33342-029-12) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK December 14, 2012
33342-029-60 33342-029 Macleods Pharmaceuticals Limited 4 BLISTER PACK in 1 CARTON (33342-029-60) / 7 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK December 14, 2012
33342-030-06 33342-030 Macleods Pharmaceuticals Limited 3 BLISTER PACK in 1 CARTON (33342-030-06) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK December 14, 2012
33342-030-07 33342-030 Macleods Pharmaceuticals Limited 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (33342-030-07) December 14, 2012
33342-030-12 33342-030 Macleods Pharmaceuticals Limited 10 BLISTER PACK in 1 CARTON (33342-030-12) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK December 14, 2012
33342-030-60 33342-030 Macleods Pharmaceuticals Limited 4 BLISTER PACK in 1 CARTON (33342-030-60) / 7 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK December 14, 2012
29300-250-87 29300-250 Unichem Pharmaceuticals (USA), Inc. 3 BLISTER PACK in 1 CARTON (29300-250-87) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (29300-250-11) February 28, 2018
29300-251-87 29300-251 Unichem Pharmaceuticals (USA), Inc. 3 BLISTER PACK in 1 CARTON (29300-251-87) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (29300-251-11) February 28, 2018
33342-029 33342-029 Macleods Pharmaceuticals Limited — December 14, 2012
33342-030 33342-030 Macleods Pharmaceuticals Limited — December 14, 2012
29300-250 29300-250 Unichem Pharmaceuticals (USA), Inc. — November 10, 2016
29300-251 29300-251 Unichem Pharmaceuticals (USA), Inc. — November 10, 2016

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.