Quick answers
- What is Donepezil hydrochloride used for?
- The FDA-approved label (Aricept, Eisai Inc., December 30, 2021) says: “ARICEPT is indicated for the treatment of dementia of the Alzheimer’s type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s disease. ARICEPT is an acetylcholinesterase inhibitor indicated for the treatment of dementia of the Alzheimer’s type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s Disease” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Donepezil hydrochloride have a boxed warning?
- No. None of the 47 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Donepezil hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Donepezil hydrochloride been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started January 26, 2022 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Donepezil hydrochloride?
- 32 companies list prescription products of Donepezil hydrochloride in the FDA NDC Directory, including Bryant Ranch Prepack, Macleods Pharmaceuticals Limited and Unichem Pharmaceuticals (USA), Inc..
What Donepezil hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ARICEPT is indicated for the treatment of dementia of the Alzheimer’s type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s disease. ARICEPT is an acetylcholinesterase inhibitor indicated for the treatment of dementia of the Alzheimer’s type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s Disease
— FDA label: Aricept, Eisai Inc., effective December 30, 2021. Read the full label on DailyMed →
The FDA has 47 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 47 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet · Tablet, orally disintegrating |
|---|---|
| Route | Oral |
| Prescription products | 73 in the FDA NDC Directory |
| Brand names | Aricept |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| donepezil hydrochloride 10 mg tablet | Generic | $0.0489 per tablet |
| donepezil hydrochloride 10 mg tablet, film coated | Generic | $0.0489 per tablet |
| donepezil hydrochloride 10 mg tablet, orally disintegrating | Generic | $0.3073 per tablet |
| donepezil hydrochloride 23 mg tablet, film coated | Generic | $0.7712 per tablet |
| donepezil hydrochloride 5 mg tablet | Generic | $0.0431 per tablet |
| donepezil hydrochloride 5 mg tablet, film coated | Generic | $0.0431 per tablet |
| donepezil hydrochloride 5 mg tablet, orally disintegrating | Generic | $0.2762 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack8 products
- Macleods Pharmaceuticals Limited5 products
- Unichem Pharmaceuticals (USA), Inc.4 products
- Solco Healthcare US, LLC4 products
- A-S Medication Solutions4 products
- Golden State Medical Supply, Inc.3 products
- Remedyrepack Inc.3 products
- Eisai Inc.3 products
- Rising Pharma Holdings, Inc.2 products
- Preferred Pharmaceuticals Inc.2 products
- Major Pharmaceuticals2 products
- Torrent Pharmaceuticals Limited2 products
- ScieGen Pharmaceuticals, Inc.2 products
- NCS HealthCare of KY, LLC dba Vangard Labs2 products
- Asclemed USA, Inc.2 products
- Alembic Pharmaceuticals Limited2 products
- Cardinal Health 107, LLC2 products
- American Health Packaging2 products
- Cadila Pharmaceuticals Limited2 products
- Alembic Pharmaceuticals Inc.2 products
- Quallent Pharmaceuticals Health LLC2 products
- Aurobindo Pharma Limited2 products
- Camber Pharmaceuticals, Inc.2 products
- Sun Pharmaceutical Industries, Inc.1 product
- Direct_Rx1 product
- Dr. Reddys Laboratories Limited1 product
- Lupin Pharmaceuticals, Inc.1 product
- Coupler LLC1 product
- Upsher-Smith Laboratories, LLC1 product
- Edenbridge Pharmaceuticals LLC.1 product
- Proficient Rx LP1 product
- DirectRx1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020690 ARICEPT | Eisai Inc | November 25, 1996 | 24, latest December 18, 2018 2018: Labeling · 2015: Labeling · 2013: Labeling |
| NDA022568 ARICEPT | Eisai Inc | July 23, 2010 | 6, latest December 18, 2018 2018: Labeling · 2015: Labeling · 2013: Labeling |
Generic approvals (18)
- ANDA078662Strides Pharma · May 31, 2011
- ANDA090056Aurobindo · May 31, 2011
- ANDA090686Torrent Pharms · May 31, 2011
- ANDA200292Prinston Inc · May 31, 2011
- ANDA201146Macleods Pharms Ltd · August 17, 2012
- ANDA201787Macleods Pharms Ltd · December 14, 2012
- ANDA201724Alembic Pharms Ltd · February 25, 2013
- ANDA202723DR Reddys · July 24, 2013
- ANDA202631Macleods Pharms · January 22, 2014
- ANDA203104Twi Pharms · October 29, 2014
- ANDA203907Sciegen Pharms · October 29, 2014
- ANDA203034Hetero Labs Ltd V · January 30, 2015
- ANDA204293Sun Pharm · June 5, 2015
- ANDA202782Lupin · October 30, 2015
- ANDA203713Dexcel · February 19, 2016
- ANDA203656Unichem · June 23, 2016
- ANDA204831Unichem · November 10, 2016
- ANDA204609Cadila Pharms Ltd · September 19, 2017
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
January 26, 2022 · Class II · Terminated · D-0176-2024
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Donepezil HCl Tablets, 10 mg, 90 Tablets, Rx only, Distributed by: Solco Healthcare U.S. LLC, Hurracao, Puerto Rico 00791. NDC: 43547-276-09 — CARDINAL HEALTHCARE
-
January 26, 2022 · Class II · Terminated · D-0177-2024
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Donepezil HCl Tablets, 5 mg, 90 Tablets, Rx only, Distributed by: Solco Healthcare U.S. LLC, Hurracao, Puerto Rico 00791. NDC: 43547-275-09 — CARDINAL HEALTHCARE
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Aricept, Eisai Inc., effective December 30, 2021; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →