Prescription medicine
Donepezil Brand names: Aricept
Donepezil (Aricept) is a prescription medicine with an FDA approval on record since 1996. FDA's NDC Directory lists it from 31 generic labelers, and pharmacies paid $0.0484 per donepezil HCl 10 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the donepezil FDA label on DailyMed (effective December 30, 2021, Eisai Inc.); the NDA 20690 record on Drugs@FDA; every donepezil label on DailyMed.
Highlights of the record
FDA label of December 30, 2021; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageARICEPT is indicated for the treatment of dementia of the Alzheimer’s type.
Forms and strengths
- 5 mg
- 10 mg
- 23 mg
Film-coated tablet; tablet; orally disintegrating tablet.
On the market
- Earliest approval on file
- November 25, 1996 Aricept, Eisai Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 47 first December 11, 2009; 22 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 32 of which 31 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- August 11, 2038 Adlarity system; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.0484 per tablet Donepezil HCl 10 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 5 since 2016 0 Class I among all firms' recalls; latest January 26, 2022
- FAERS reports
- 36,484 through July 30, 2026
What is donepezil used for?
From the label: indications and usageARICEPT 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
Conditions named in the indications of donepezil's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Cholinesterase Inhibitor.
Source: FDA drug label (Aricept), Eisai Inc., effective December 30, 2021 (SPL set 98e451e1-e4d7-4439-a675-c5457ba20975), via openFDA; the full label on DailyMed
Is there a generic for donepezil (Aricept)?
The FDA approved the first generic donepezil on December 11, 2009. 47 generic applications are approved; 22 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists donepezil from 31 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Aricept tablets; a patent listed only for Adlarity system runs to August 11, 2038. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1996 earliest approval on file
- 2009 first generic approved
- 2038 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for donepezil (Aricept)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0484 per Donepezil HCl 10 mg tablet, about the same as a year earlier. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Donepezil HCl 5 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Donepezil HCl 10 mg tablet | Generic | $0.0484 per tablet | $1.45 | -0.9% |
| Donepezil HCl 23 mg tablet | Generic | $0.735 per tablet | $22.06 | -13% |
| Donepezil HCl 5 mg tablet | Generic | $0.044 per tablet | $1.32 | +2% |
| Donepezil HCl ODT 10 mg tablet | Generic | $0.291 per tablet | $8.74 | -9% |
| Donepezil HCl ODT 5 mg tablet | Generic | $0.281 per tablet | $8.42 | +0.5% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has donepezil been recalled?
The FDA's Enforcement Report lists 5 recalls naming donepezil since 2016: 0 Class I (the most serious), 2 Class II, 3 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| January 26, 2022 | Class II | CARDINAL HEALTHCARE | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. |
| August 20, 2021 | Class III | Jubilant Cadista Pharmaceuticals, Inc. | Subpotent |
| January 4, 2017 | Class III | Mckesson Packaging Services | Supotent: Out of Specification result for assay test during routine stability testing. |
| December 13, 2016 | Class III | Sandoz Inc | Subpotent Drug: out of specification results for assay test. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the donepezil label say about other medicines?
The donepezil label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name donepezil. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Bethanechol | drug interactions | Cholinomimetics and Other Cholinesterase Inhibitors A synergistic effect may be expected when cholinesterase inhibitors are given concurrently with succinylcholine, similar neuromuscular blocking agents, or cholinergic agonists such as bethanechol. |
| Succinylcholine | drug interactions | DRUG INTERACTIONS Cholinesterase inhibitors have the potential to interfere with the activity of anticholinergic medications ( 7.1 ) A synergistic effect may be expected with concomitant administration of succinylcholine, similar neuromuscular blocking agents, or cholinergic agonists |
Other labels that name donepezil
Source: FDA drug label (Aricept), Eisai Inc., effective December 30, 2021 (SPL set 98e451e1-e4d7-4439-a675-c5457ba20975), via openFDA; the full label on DailyMed
What do FAERS reports show for donepezil?
The FDA Adverse Event Reporting System holds 36,484 reports that list donepezil among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 5,805 are coded as a death and 14,622 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as donepezil?
3 other medicines are given the same way (oral) and in the same FDA class as donepezil or labeled mainly for the same use (alzheimer's disease), the same class first. Alzheimer's disease lists all 7 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Rivastigmine | Alzheimer's disease | 11 labelers | $0.164 per capsule 1.5 mg capsule | A presentation being discontinued |
| Galantamine | Alzheimer's disease | 9 labelers | $0.294 per tablet 4 mg tablet | No current entry |
| Memantine | Alzheimer's disease | 38 labelers | $0.063 per tablet 10 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does donepezil compare with medicines for the same use?
3 side-by-side pages set donepezil beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to donepezil
- 3 medicines for the same use
- Other cholinesterase inhibitors
- the pharmacologic class, with prices and generics
- Donepezil side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other