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donepezil hydrochloride 10 mg Tablet, Film Coated, 1,000-count — NDC 29300-0249-10 package photo
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donepezil hydrochloride 10 mg Tablet, Film Coated, 1,000-count — NDC 29300-249-10 (Billing 29300-0249-10)

by Unichem Pharmaceuticals (USA), Inc. · 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

This is a package of 1,000 tablets of donepezil hydrochloride 10 mg Tablet, Film Coated from Unichem Pharmaceuticals (USA), Inc., marketed since Jun 2016 and currently FDA-listed.

NDC 29300-0249-10
🏷️ FDA NDC (as labeled) 29300-249-10 billing pads the product segment with a zero
This package
Contains1,000-count Pack sizes4 compare ↓
Also priced by: Part D plans $0.1339/unit — full pricing hub ↓
Product page 29300-0249-01 Also comes in: 30 tablets 29300-249-13 90 tablets 29300-249-19 100 tablets 29300-249-01
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 29300-249-10
Product NDC 29300-249
11-digit billing NDC 29300024910
RxCUI 997220, 997223, 997226, 997229
UNII 3O2T2PJ89D
Application # ANDA203656
SPL Set ID 1a8906ce-96dc-4bc8-81c1-5db67a187aac
Established class (EPC) Cholinesterase Inhibitor
Mechanism of action Cholinesterase Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-06-23
Route ORAL
Dosage form TABLET, FILM COATED
Substance DONEPEZIL HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 997220
Why two NDCs? The FDA registers this code as 29300-249-10 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 29300-0249-10. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Cholinesterase Inhibitor class.

Pharmacologic class Cholinesterase Inhibitor
Drug family (ATC) Anticholinesterases
How it works Cholinesterase Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📗 Our plain-language guide HelloPharmacist
  • Unfortunately, no — donepezil doesn't cure Alzheimer's disease, and it won't stop the disease from progressing over time. What it can do is help manage symptoms like memory and thi...
  • Will donepezil cure my family member's Alzheimer's disease?
  • You should take donepezil once a day in the evening, just before going to bed. Food doesn't affect how well it's absorbed, so you can take it with or without a meal — whatever work...
  • When should I take donepezil, and does it matter if I take it with food?
📖 Read our full Donepezil guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.1339 $133.90 / 1000 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
29300-0249-01 29300-249-01 Main listing 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2018-02-28 — Active
29300-0249-10 You're viewing this 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2018-02-28 — Active
29300-0249-13 29300-249-13 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2018-02-28 — Active
29300-0249-19 29300-249-19 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2018-02-28 — Active

You're viewing the largest of 4 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 1,000-count package — 1000 tablet, film coated in 1 bottle, plastic.
How does this package differ from NDC 29300-0249-13?
Both are donepezil hydrochloride 10 mg Tablet, Film Coated — the drug itself is identical. This page's package is the 1,000-count one, while NDC 29300-0249-13 is the 30 tablets package.
What NDC number is used to bill for this package of donepezil hydrochloride 10 mg Tablet, Film Coated?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Donepezil hydrochloride 10 mg 55111-0357-05 Dr. 500 tablets $0.048 AB Discontinued —
Donepezil Hydrochloride 10 mg 00904-6478-61 Major 1 tablet $0.048 AB Availability likely —
Donepezil Hydrochloride 10 mg 16571-0779-03 Rising 30 tablets $0.048 AB Availability likely —
Donepezil Hydrochloride 10 mg 33342-0028-07 Macleods 30 tablets $0.048 AB Availability likely —
donepezil hydrochloride 10 mg 43547-0276-03 Solco 30 tablets $0.048 AB Availability likely —
Donepezil 10 mg 60687-0303-01 American 100 tablets $0.048 AB Availability likely —
Donepezil Hydrochloride 10 mg 71093-0128-01 ACI 30 tablets $0.048 — Discontinued —
Donepezil 10 mg 82009-0120-05 Quallent 500 tablets $0.048 AB Availability likely —
Aricept 10 mg 62856-0246-30 Eisai 30 tablets $16.197 AB FDA listed —
Donepezil Hydrochloride 10 mg 00615-8313-05 NCS 15 tablets — AB FDA listed —
Donepezil Hydrochloride 10 mg 13668-0103-05 Torrent 500 tablets — AB FDA listed —
donepezil hydrochloride 10 mgthis 29300-0249-10 Unichem 1000 tablets — — FDA listed —
Donepezil 10 mg 31722-0738-01 Camber 100 tablets — AB FDA listed —
donepezil hydrochloride 10 mg 43547-0879-03 Solco 30 tablets — AB FDA listed —
Donepezil Hydrochloride 10 mg 46708-0296-10 Alembic 100 tablets — AB FDA listed —
Donepezil 10 mg 50090-2627-00 A-S 90 tablets — AB FDA listed —
Donepezil Hydrochloride 10 mg 50228-0140-10 ScieGen 1000 tablets — AB FDA listed —
Donepezil Hydrochloride 10 mg 55154-7882-00 Cardinal 1 tablet — AB FDA listed —
Donepezil Hydrochloride 10 mg 60429-0322-10 Golden 1000 tablets — AB FDA listed —
Donepezil Hydrochloride 10 mg 62332-0093-10 Alembic 100 tablets — AB FDA listed —
Donepezil Hydrochloride 10 mg 65862-0326-01 Aurobindo 100 tablets — — FDA listed —
donepezil hydrochloride 10 mg 70518-1666-00 REMEDYREPACK 90 tablets — AB FDA listed —
Donepezil Hydrochloride 10 mg 71209-0020-01 Cadila 30 tablets — AB FDA listed —
Donepezil Hydrochloride 10 mg 71335-0416-01 Bryant 30 tablets — AB FDA listed —
donepezil hydrochloride 10 mg 71335-0900-01 Bryant 30 tablets — AB FDA listed —
Donepezil Hydrochloride 10 mg 71335-2346-01 Bryant 30 tablets — AB FDA listed —
Donepezil Hydrochloride 10 mg 71335-2436-01 Bryant 30 tablets — — Discontinued —
Donepezil Hydrochloride 10 mg 72162-2137-00 Bryant 1000 tablets — — Discontinued —
Donepezil Hydrochloride 10 mg 72189-0265-90 DirectRx 90 tablets — AB FDA listed —
donepezil hydrochloride 10 mg 87063-0304-01 ASCLEMED 100 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2016
On the market since
Jun 2016
📍
2026
Currently FDA-listed
10 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color White / Yellow
ShapeRound
ImprintU;251
Size1 mm
ScoringNot scored
FlavorOrange
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerUnichem Pharmaceuticals (USA), Inc.
Application holderUNICHEM LABORATORIES LTD
FDA applicationANDA203656 (ANDA)
Labeler code29300
First marketedJun 2016
Product typeHuman Prescription Drug
Portfolio210 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 62 words ▾

1 INDICATIONS AND USAGE Donepezil hydrochloride 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 ( 1 ) Donepezil hydrochloride 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.

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION Mild to Moderate Alzheimer's Disease: 5 mg to 10 mg once daily ( 2.1 ) Moderate to Severe Alzheimer's Disease: 10 mg to 23 mg once daily ( 2.2 )

2.1Dosing in Mild to Moderate Alzheimer's Disease The recommended starting dosage of donepezil hydrochloride is 5 mg administered once per day in the evening, just prior to retiring. The maximum recommended dosage of donepezil hydrochloride in patients with mild to moderate Alzheimer's disease is 10 mg per day. A dose of 10 mg should not be administered until patients have been on a daily dose of 5 mg for 4 to 6 weeks

2.2Dosing in Moderate to Severe Alzheimer's Disease The recommended starting dosage of donepezil hydrochloride is 5 mg administered once per day in the evening, just prior to retiring. The maximum recommended dosage of donepezil hydrochloride in patients with moderate to severe Alzheimer's disease is 23 mg per day. A dose of 10 mg should not be administered until patients have been on a daily dose of 5 mg for 4 to 6 weeks.

A dose of 23 mg per day should not be administered until patients have been on a daily dose of 10 mg for at least 3 months.

2.3Administration Information Donepezil hydrochloride tablet should be taken in the evening, just prior to retiring. Donepezil hydrochloride tablet can be taken with or without food. Allow donepezil hydrochloride ODT to dissolve on the tongue and follow with water.

💊 Dosage Forms and Strengths 154 words ▾

3 DOSAGE FORMS AND STRENGTHS Tablets: 5 mg and 10 mg ( 3 ) Orally Disintegrating Tablets (ODT): 5 mg and 10 mg Donepezil hydrochloride tablets USP are supplied as film-coated, round tablets containing 5 mg or 10 mg of donepezil hydrochloride. The 5 mg tablets are white, round, biconvex, film-coated tablets with '248' debossed on one side and 'U' on other side. The 10 mg tablets are yellow, round, biconvex, film-coated tablets with '249' debossed on one side and 'U' on other side.

Donepezil hydrochloride orally disintegrating tablets USP are supplied as round tablets containing 5 mg or 10 mg of donepezil hydrochloride. The 5 mg orally disintegrating tablets are white, round, flat faced beveled edged tablets debossed with '250' on one side and 'U' on other side. The 10 mg orally disintegrating tablets are yellow, round, flat faced beveled edged tablets debossed with '251' on one side and 'U' on other side.

⛔ Contraindications 30 words ▾

4 CONTRAINDICATIONS Known hypersensitivity to donepezil hydrochloride or to piperidine derivatives ( 4 ) Donepezil hydrochloride is contraindicated in patients with known hypersensitivity to donepezil hydrochloride or to piperidine derivatives.

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Cholinesterase inhibitors are likely to exaggerate succinylcholine-type muscle relaxation during anesthesia ( 5.1 ) Cholinesterase inhibitors may have vagotonic effects on the sinoatrial and trioventricular nodes manifesting as bradycardia or heart block ( 5.2 ) Donepezil hydrochloride can cause vomiting. Patients should be observed closely at initiation of treatment and after dose increases ( 5.3 ) Patients should be monitored closely for symptoms of active or occult gastrointestinal (GI) bleeding, especially those at increased risk for developing ulcers ( 5.4 ) The use of donepezil hydrochloride in a dose of 23 mg once daily is associated with weight loss ( 5.5 ) Cholinomimetics may cause bladder outflow obstructions ( 5.6 ) Cholinomimetics are believed to have some potential to cause generalized convulsions ( 5.7 ) Cholinesterase inhibitors should be prescribed with care to patients with a history of asthma or obstructive pulmonary disease ( 5.8 )

5.1Anesthesia Donepezil hydrochloride, as a cholinesterase inhibitor, is likely to exaggerate succinylcholine type muscle relaxation during anesthesia.

5.2Cardiovascular Conditions Because of their pharmacological action, cholinesterase inhibitors may have vagotonic effects on the sinoatrial and atrioventricular nodes. This effect may manifest as bradycardia or heart block in patients both with and without known underlying cardiac conduction abnormalities. Syncopal episodes have been reported in association with the use of donepezil hydrochloride.

5.3Nausea and Vomiting Donepezil hydrochloride, as a predictable consequence of its pharmacological properties, has been shown to produce diarrhea, nausea, and vomiting. These effects, when they occur, appear more frequently with the 10 mg/day dose than with the 5 mg/day dose, and more frequently with the 23 mg dose than with the 10 mg dose. Specifically, in a controlled trial that compared a dose of 23 mg/day to 10 mg/day in patients who had been treated with donepezil 10 mg/day for at least three months, the incidence of nausea in the 23 mg group was markedly greater than in the patients who continued on 10 mg/day (11.8% vs.

3.4%, respectively), and the incidence of vomiting in the 23 mg group was markedly greater than in the 10 mg group (9.2% vs. 2.5%, respectively). The percent of patients who discontinued treatment due to vomiting in the 23 mg group was markedly higher than in the 10 mg group (2.9% vs.

0.4%, respectively). Although in most cases, these effects have been transient, sometimes lasting one to three weeks, and have resolved during continued use of donepezil hydrochloride, patients should be observed closely at the initiation of treatment and after dose increases.

5.4Peptic Ulcer Disease and GI Bleeding Through their primary action, cholinesterase inhibitors may be expected to increase gastric acid secretion due to increased cholinergic activity. Therefore, patients should be monitored closely for symptoms of active or occult gastrointestinal bleeding, especially those at increased risk for developing ulcers, e.g., those with a history of ulcer disease or those receiving concurrent nonsteroidal anti-inflammatory drugs (NSAIDs). Clinical studies of donepezil hydrochloride in a dose of 5 mg/day to 10 mg/day have shown no increase, relative to placebo, in the incidence of either peptic ulcer disease or gastrointestinal bleeding.

Results of a controlled clinical study with 23 mg/day showed an increase, relative to 10 mg/day, in the incidence of peptic ulcer disease (0.4% vs. 0.2%) and gastrointestinal bleeding from any site (1.1% vs. 0.6%).

5.5Weight Loss Weight loss was reported as an adverse reaction in 4.7% of patients assigned to donepezil hydrochloride in a dose of 23 mg/day compared to 2.5% of patients assigned to 10 mg/day. Compared to their baseline weights, 8.4% of patients taking 23 mg/day were found to have a weight decrease of ≥ 7% by the end of the study, while 4.9% of patients tak…

⚠️ Warnings ~3 min read ▾

PATIENT PACKAGE INSERT Donepezil Hydrochloride Tablets USP (doe nep' e zil hye'' droe klor' ide) Tablets: 5 mg and 10 mg Donepezil Hydrochloride Orally Disintegrating Tablets USP (doe nep' e zil hye'' droe klor' ide oh-dee-tee) ODT Tablets: 5 mg and 10 mg Read this Patient Information that comes with donepezil hydrochloride tablets and donepezil hydrochloride ODT before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about Alzheimer's disease or treatment for it.

If you have questions, ask the doctor or pharmacist. What is donepezil hydrochloride? Donepezil hydrochloride comes as donepezil hydrochloride film-coated tablets in dosage strengths of 5 mg and 10 mg, and as donepezil hydrochloride orally disintegrating tablets (ODT; 5 mg and 10 mg).

Except where indicated, all the information about donepezil hydrochloride tablets in this leaflet also applies to donepezil hydrochloride ODT. Donepezil hydrochloride is a prescription medicine to treat mild, moderate, and severe Alzheimer's disease. Donepezil hydrochloride can help with mental function and with doing daily tasks.

Donepezil hydrochloride does not work the same in all people. Some people may: Seem much better Get better in small ways or stay the same Get worse over time but slower than expected Not change and then get worse as expected Donepezil hydrochloride does not cure Alzheimer's disease. All patients with Alzheimer's disease get worse over time, even if they take donepezil hydrochloride.

Donepezil hydrochloride has not been approved as a treatment for any medical condition in children. Who should not take donepezil hydrochloride? Do not take donepezil hydrochloride if you are allergic to any of the ingredients in donepezil hydrochloride tablets and donepezil hydrochloride ODT or to medicines that contain piperidines.

Ask your doctor if you are not sure. See the end of this leaflet for a list of ingredients in donepezil hydrochloride tablets and donepezil hydrochloride ODT. What should I tell my doctor before taking donepezil hydrochloride?

Tell the doctor about all of your present or past health problems and conditions. Include: Any heart problems including problems with irregular, slow, or fast heartbeats Asthma or lung problems A seizure Stomach ulcers Difficulty passing urine Liver or kidney problems Trouble swallowing tablets Present pregnancy or plans to become pregnant. It is not known if donepezil hydrochloride can harm an unborn baby.

Present breast-feeding. It is not known if donepezil hydrochloride passes into breast milk. Talk to your doctor about the best way to feed your baby if you take donepezil hydrochloride.

Tell the doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal products. Donepezil hydrochloride and other medicines may affect each other. Be particularly sure to tell the doctor if you take aspirin or medicines called nonsteroidal anti-inflammatory drugs (NSAIDs).

There are many NSAID medicines, both prescription and non-prescription. Ask the doctor or pharmacist if you are not sure if any of your medicines are NSAIDs. Taking NSAIDs and donepezil hydrochloride together may make you more likely to get stomach ulcers.

Donepezil hydrochloride taken with certain medicines used for anesthesia may cause side effects. Tell the responsible doctor or dentist that you take donepezil hydrochloride before you have: surgery medical procedures dental surgery or procedures. Know the medicines that you take.

Keep a list of all your medicines. Show it to your doctor or pharmacist before you start a new medicine. How should you take donepezil hydrochloride?

Take donepezil hydrochloride exactly as prescribed by the doctor. Do not stop donepezil hydrochloride or change the dose yourself. Talk with your doctor first.

Take donepezil hydrochloride one time each day. Donepezil hydrochloride can be taken with…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS Most common adverse reactions in clinical studies of donepezil hydrochloride are nausea, diarrhea, insomnia, vomiting, muscle cramps, fatigue, and anorexia ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Unichem Pharmaceuticals (USA) Inc. at 1-866-562-4616 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The following serious adverse reactions are described below and elsewhere in the labeling: Cardiovascular Conditions [see Warnings and Precautions ( 5.2 )] Nausea and Vomiting [see Warnings and Precautions ( 5.3 )] Peptic Ulcer Disease and GI Bleeding [see Warnings and Precautions ( 5.4 )] Weight Loss [see Warnings and Precautions ( 5.5 )] Genitourinary Conditions [see Warnings and Precautions ( 5.6 )] Neurological Conditions: Seizures [see Warnings and Precautions ( 5.7 )] Pulmonary Conditions [see Warnings and Precautions ( 5.8 )]

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Donepezil hydrochloride has been administered to over 1,700 individuals during clinical trials worldwide. Approximately 1200 of these patients have been treated for at least 3 months and more than 1,000 patients have been treated for at least 6 months.

Controlled and uncontrolled trials in the United States included approximately 900 patients. In regards to the highest dose of 10 mg/day, this population includes 650 patients treated for 3 months, 475 patients treated for 6 months, and 116 patients treated for over 1 year. The range of patient exposure is from 1 to 1,214 days.

Mild to Moderate Alzheimer's Disease Adverse Reactions Leading to Discontinuation The rates of discontinuation from controlled clinical trials of donepezil hydrochloride due to adverse reactions for the donepezil hydrochloride 5 mg/day treatment groups were comparable to those of placebo treatment groups at approximately 5%. The rate of discontinuation of patients who received 7-day escalations from 5 mg/day to 10 mg/day was higher at 13%. The most common adverse reactions leading to discontinuation, defined as those occurring in at least 2% of patients and at twice or more the incidence seen in placebo patients, are shown in Table 1.

Table 1 . Most Common Adverse Reactions Leading to Discontinuation in Patients with Mild to Moderate Alzheimer’s Disease Adverse Reaction Placebo ( n = 355 ) % 5 mg / day Donepezil hydrochloride ( n = 350 ) % 10 mg / day Donepezil hydrochloride ( n = 315 ) % Nausea 1 1 3 Diarrhea 0 <1 3 Vomiting <1 <1 2 Most Common Adverse Reactions The most common adverse reactions, defined as those occurring at a frequency of at least 5% in patients receiving 10 mg/day and twice the placebo rate, are largely predicted by donepezil hydrochloride's cholinomimetic effects.

These include nausea, diarrhea, insomnia, vomiting, muscle cramp, fatigue, and anorexia. These adverse reactions were often transient, resolving during continued donepezil hydrochloride treatment without the need for dose modification. There is evidence to suggest that the frequency of these common adverse reactions may be affected by the rate of titration.

An open-label study was conducted with 269 patients who received placebo in the 15-and 30-week studies. These patients were titrated to a dose of 10 mg/day over a 6-week period. The rates of common adverse reactions were lower than those seen in patients titrated to 10 mg/day over one week in the controlled clinical trials and were comparable to those seen in patients on 5 mg/day.

See Table 2 for a comparison of the most common adverse reactions following one and six week titration regimens. Table 2. Comparison of Rates of Adverse Reactions in Mild to Moderate Patients Titrated to 10 mg/day over 1 and 6 Weeks No titration One week titration Six week titration Adverse Reaction…

🔄 Drug Interactions 95 words ▾

7 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 ( 7.2 )

7.1Use with Anticholinergics Because of their mechanism of action, cholinesterase inhibitors have the potential to interfere with the activity of anticholinergic medications.

7.2Use with 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.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm ( 8.1 )

8.1Pregnancy Risk Summary There are no adequate data on the developmental risks associated with the use of donepezil hydrochloride in pregnant women. In animal studies, developmental toxicity was not observed when donepezil was administered to pregnant rats and rabbits during organogenesis, but administration to rats during the latter part of pregnancy and throughout lactation resulted in increased stillbirths and decreased offspring survival at clinically relevant doses [see Data]. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively.

The background risks of major birth defects and miscarriage for the indicated population are unknown. Data Animal Data Oral administration of donepezil to pregnant rats and rabbits during the period of organogenesis did not produce any teratogenic effects at doses up to 16 mg/kg/day (approximately 6 times the maximum recommended human dose [MRHD] of 23 mg/day on a mg/m 2 basis) and 10 mg/kg/day (approximately 7 times the MRHD on a mg/m 2 basis), respectively. Oral administration of donepezil (1, 3, 10 mg/kg/day) to rats during late gestation and throughout lactation to weaning produced an increase in stillbirths and reduced offspring survival through postpartum day 4 at the highest dose.

The no-effect dose of 3 mg/kg/day is approximately equal to the MRHD on a mg/m 2 basis.

8.2Lactation Risk Summary There are no data on the presence of donepezil or its metabolites in human milk, the effects on the breastfed infant, or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for donepezil hydrochloride and any potential adverse effects on the breastfed infant from donepezil hydrochloride or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness in pediatric patients have not been established.

8.5Geriatric Use Alzheimer's disease is a disorder occurring primarily in individuals over 55 years of age. The mean age of patients enrolled in the clinical studies with donepezil hydrochloride was 73 years; 80% of these patients were between 65 and 84 years old, and 49% of patients were at or above the age of 75. The efficacy and safety data presented in the clinical trials section were obtained from these patients.

There were no clinically significant differences in most adverse reactions reported by patient groups ≥ 65 years old and < 65 years old.

8.6Lower Weight Individuals In the controlled clinical trial, among patients in the donepezil hydrochloride 23 mg treatment group, those patients weighing < 55 kg reported more nausea, vomiting, and decreased weight than patients weighing 55 kg or more. There were more withdrawals due to adverse reactions as well. This finding may be related to higher plasma exposure associated with lower weight.

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary There are no adequate data on the developmental risks associated with the use of donepezil hydrochloride in pregnant women. In animal studies, developmental toxicity was not observed when donepezil was administered to pregnant rats and rabbits during organogenesis, but administration to rats during the latter part of pregnancy and throughout lactation resulted in increased stillbirths and decreased offspring survival at clinically relevant doses [see Data]. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively.

The background risks of major birth defects and miscarriage for the indicated population are unknown. Data Animal Data Oral administration of donepezil to pregnant rats and rabbits during the period of organogenesis did not produce any teratogenic effects at doses up to 16 mg/kg/day (approximately 6 times the maximum recommended human dose [MRHD] of 23 mg/day on a mg/m 2 basis) and 10 mg/kg/day (approximately 7 times the MRHD on a mg/m 2 basis), respectively. Oral administration of donepezil (1, 3, 10 mg/kg/day) to rats during late gestation and throughout lactation to weaning produced an increase in stillbirths and reduced offspring survival through postpartum day 4 at the highest dose.

The no-effect dose of 3 mg/kg/day is approximately equal to the MRHD on a mg/m 2 basis.

🧒 Pediatric Use 14 words ▾

8.4Pediatric Use The safety and effectiveness in pediatric patients have not been established.

🧓 Geriatric Use 95 words ▾

8.5Geriatric Use Alzheimer's disease is a disorder occurring primarily in individuals over 55 years of age. The mean age of patients enrolled in the clinical studies with donepezil hydrochloride was 73 years; 80% of these patients were between 65 and 84 years old, and 49% of patients were at or above the age of 75. The efficacy and safety data presented in the clinical trials section were obtained from these patients.

There were no clinically significant differences in most adverse reactions reported by patient groups ≥ 65 years old and < 65 years old.

🆘 Overdosage 195 words ▾

10 OVERDOSAGE Because strategies for the management of overdose are continually evolving, it is advisable to contact a Poison Control Center to determine the latest recommendations for the management of an overdose of any drug. As in any case of overdose, general supportive measures should be utilized. Overdosage with cholinesterase inhibitors can result in cholinergic crisis characterized by severe nausea, vomiting, salivation, sweating, bradycardia, hypotension, respiratory depression, collapse, and convulsions.

Increasing muscle weakness is a possibility and may result in death if respiratory muscles are involved. Tertiary anticholinergics such as atropine may be used as an antidote for donepezil hydrochloride overdosage. Intravenous atropine sulfate titrated to effect is recommended: an initial dose of 1.0 to 2.0 mg IV with subsequent doses based upon clinical response.

Atypical responses in blood pressure and heart rate have been reported with other cholinomimetics when co-administered with quaternary anticholinergics such as glycopyrrolate. It is not known whether donepezil hydrochloride and/or its metabolites can be removed by dialysis (hemodialysis, peritoneal dialysis, or hemofiltration). Dose-related signs of toxicity in animals included reduced spontaneous movement, prone position, staggering gait, lacrimation, clonic convulsions, depressed respiration, salivation, miosis, tremors, fasciculation, and lower body surface temperature.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Current theories on the pathogenesis of the cognitive signs and symptoms of Alzheimer's disease attribute some of them to a deficiency of cholinergic neurotransmission. Donepezil hydrochloride is postulated to exert its therapeutic effect by enhancing cholinergic function. This is accomplished by increasing the concentration of acetylcholine through reversible inhibition of its hydrolysis by acetylcholinesterase.

There is no evidence that donepezil alters the course of the underlying dementing process.

12.3Pharmacokinetics Pharmacokinetics of donepezil are linear over a dose range of 1-10 mg given once daily. The rate and extent of absorption of donepezil hydrochloride tablets are not influenced by food. Based on population pharmacokinetic analysis of plasma donepezil concentrations measured in patients with Alzheimer's disease, following oral dosing, peak plasma concentration is achieved for donepezil hydrochloride 23 mg tablets in approximately 8 hours, compared with 3 hours for donepezil hydrochloride 10 mg tablets.

Peak plasma concentrations were about 2-fold higher for donepezil hydrochloride 23 mg tablets than donepezil hydrochloride 10 mg tablets. Donepezil hydrochloride ODT 5 mg and 10 mg are bioequivalent to donepezil hydrochloride 5 mg and 10 mg tablets, respectively. A food effect study has not been conducted with donepezil hydrochloride ODT; however, the effect of food with donepezil hydrochloride ODT is expected to be minimal.

Donepezil hydrochloride ODT can be taken without regard to meals. The elimination half life of donepezil is about 70 hours, and the mean apparent plasma clearance (Cl/F) is 0.13-0.19 L/hr/kg. Following multiple dose administration, donepezil accumulates in plasma by 4-7 fold, and steady state is reached within 15 days.

The steady state volume of distribution is 12-16 L/kg. Donepezil is approximately 96% bound to human plasma proteins, mainly to albumins (about 75%) and alpha 1 - acid glycoprotein (about 21%) over the concentration range of 2-1000 ng/mL. Donepezil is both excreted in the urine intact and extensively metabolized to four major metabolites, two of which are known to be active, and a number of minor metabolites, not all of which have been identified.

Donepezil is metabolized by CYP 450 isoenzymes 2D6 and 3A4 and undergoes glucuronidation. Following administration of 14 C-labeled donepezil, plasma radioactivity, expressed as a percent of the administered dose, was present primarily as intact donepezil (53%) and as 6-O-desmethyl donepezil (11%), which has been reported to inhibit AChE to the same extent as donepezil in vitro and was found in plasma at concentrations equal to about 20% of donepezil. Approximately 57% and 15% of the total radioactivity was recovered in urine and feces, respectively, over a period of 10 days, while 28% remained unrecovered, with about 17% of the donepezil dose recovered in the urine as unchanged drug.

Examination of the effect of CYP2D6 genotype in Alzheimer's patients showed differences in clearance values among CYP2D6 genotype subgroups. When compared to the extensive metabolizers, poor metabolizers had a 31.5% slower clearance and ultra-rapid metabolizers had a 24% faster clearance. Hepatic Disease In a study of 10 patients with stable alcoholic cirrhosis, the clearance of donepezil hydrochloride was decreased by 20% relative to 10 healthy age-and sex-matched subjects.

Renal Disease In a study of 11 patients with moderate to severe renal impairment (Cl C < 18 mL/min/1.73 m 2 ) the clearance of donepezil hydrochloride did not differ from 11 age-and sex-matched healthy subjects. Age No formal pharmacokinetic study was conducted to examine age-related differences in the pharmacokinetics of donepezil hydrochloride. Population pharmacokinetic analysis suggested that the clearance of donepezil in patients decreases with increasing age.

When compared with 65-year old subjects, 90-year old subjects have a…

🧬 Mechanism of Action 72 words ▾

12.1Mechanism of Action Current theories on the pathogenesis of the cognitive signs and symptoms of Alzheimer's disease attribute some of them to a deficiency of cholinergic neurotransmission. Donepezil hydrochloride is postulated to exert its therapeutic effect by enhancing cholinergic function. This is accomplished by increasing the concentration of acetylcholine through reversible inhibition of its hydrolysis by acetylcholinesterase.

There is no evidence that donepezil alters the course of the underlying dementing process.

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1Donepezil Hydrochloride Tablets USP Supplied as film-coated, round tablets containing 5 mg or 10 mg of donepezil hydrochloride. The 5 mg tablets are white, round, biconvex, film-coated tablets with '248' debossed on one side and 'U' on the other side. Bottles of 30 (NDC# 29300-248-13) Bottles of 90 (NDC# 29300-248-19) Bottles of 100 (NDC# 29300-248-01) Bottles of 1000 (NDC# 29300-248-10) The 10 mg tablets are yellow, round, biconvex, film-coated tablets with '249' debossed on one side and 'U' on the other side.

Bottles of 30 (NDC# 29300-249-13) Bottles of 90 (NDC# 29300-249-19) Bottles of 100 (NDC# 29300-249-01) Bottles of 1000 (NDC# 29300-249-10)

16.2Donepezil Hydrochloride Orally Disintegrating Tablets USP Supplied as round tablets containing either 5 mg or 10 mg of donepezil hydrochloride. The 5 mg orally disintegrating tablets are white, round, flat faced beveled edged tablets debossed with '250' on one side and 'U' on other side. Carton containing 3 blister cards of 10 tablets each (3 x 10's) (NDC 29300-250-87) The 10 mg orally disintegrating tablets are yellow, round, flat faced beveled edged tablets debossed with '251' on one side and 'U' on other side.

Carton containing 3 blister cards of 10 tablets each (3 x 10's) (NDC 29300-251-87) Storage Store at 20 o to 25 o C (68 o to 77 o F) [see USP Controlled Room Temperature].

📋 Description 207 words ▾

11 DESCRIPTION Donepezil hydrochloride is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2, 3-dihydro-5, 6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1 H -inden-1-one hydrochloride. Donepezil hydrochloride is commonly referred to in the pharmacological literature as E2020. It has a molecular formula of C 24 H 29 NO 3 HCl and a molecular weight of 415.96.

Donepezil hydrochloride is a white crystalline powder and is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrile, and practically insoluble in ethyl acetate and in n-hexane. Donepezil hydrochloride is available for oral administration in film-coated tablets containing 5 and 10 mg of donepezil hydrochloride. Inactive ingredients in 5 mg and 10 mg tablets are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate.

The film coating contains talc, polyethylene glycol, polyvinyl alcohol and titanium dioxide. Additionally, the 10 mg tablet contains yellow iron oxide as a coloring agent. Donepezil hydrochloride orally disintegrating tablets USP are available for oral administration.

Each Donepezil hydrochloride orally disintegrating tablet USP contains 5 or 10 mg of donepezil hydrochloride. Inactive ingredients are mannitol, silicified microcrystalline cellulose, low substituted hydroxypropyl cellulose, sucralose, orange flavor,sodium stearyl fumarate. Additionally, the 10 mg tablet contains iron oxide yellow as a coloring agent.

Molecular Structure

💬 Information for Patients 99 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Instruct patients and caregivers to take donepezil hydrochloride only once per day, as prescribed. Instruct patients and caregivers that donepezil hydrochloride can be taken with or without food.

Donepezil hydrochloride ODT should not be swallowed whole, but be allowed to dissolve on the tongue and followed with water. Advise patients and caregivers that donepezil hydrochloride may cause nausea, diarrhea, insomnia, vomiting, muscle cramps, fatigue, and decreased appetite. Advise patients to notify their healthcare provider if they are pregnant or plan to become pregnant.

06-R-01/2023

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
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Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Unichem Pharmaceuticals (USA), Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 30 tablets (29300-0249-13), 90 tablets (29300-0249-19), 100 tablets (29300-0249-01). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Unichem Pharmaceuticals (USA), Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 29300-0248-01 · Unichem 29300-0250-87 · Unichem →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.