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Donepezil Hydrochloride 10 mg Tablet, Film Coated, 500-count — NDC 13668-0103-05 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Donepezil Hydrochloride 10 mg Tablet, Film Coated, 500-count — NDC 13668-103-05 (Billing 13668-0103-05)

by Torrent Pharmaceuticals Limited · 500 TABLET, FILM COATED in 1 BOTTLE

This is a package of 500 tablets of Donepezil Hydrochloride 10 mg Tablet, Film Coated from Torrent Pharmaceuticals Limited, marketed since May 2011 and currently FDA-listed.

NDC 13668-0103-05
🏷️ FDA NDC (as labeled) 13668-103-05 billing pads the product segment with a zero
This package
Contains500-count Pack sizes5 compare ↓
Also priced by: Part D plans $0.1339/unit — full pricing hub ↓
Product page 13668-0103-90 Also comes in: 30 tablets 13668-103-30 90 tablets 13668-103-90 1000 tablets 13668-103-10 2650 tablets 13668-103-26
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) 13668-103-05
Product NDC 13668-103
11-digit billing NDC 13668010305
NCPDP billing unit EA — each (per item)
RxCUI 997223, 997229
UNII 3O2T2PJ89D
UPC 0313668102307, 0313668103304
Application # ANDA090686
SPL Set ID 76bf638e-dbde-418e-8977-1caf009990bc
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 2011-05-31
Route ORAL
Dosage form TABLET, FILM COATED
Substance DONEPEZIL HYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 62051025100320
GPI class Donepezil HCl
GCN Seq No 029334
GCN 04300
HICL code 012259
Ingredient (HICL) Donepezil Hcl
HIC1 code J
Therapeutic class — broad (HIC1) Autonomic Nervous System
HIC2 code J1
Therapeutic class — intermediate (HIC2) Cholinergics
HIC3 code J1B
Therapeutic class — specific (HIC3) Cholinesterase Inhibitors
AHFS code 12:04.00.00
AHFS class Parasympathomimetic (Cholinergic Agents)
FDB label name DONEPEZIL HCL 10 MG TABLET
FDB brand name Donepezil Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 029334
  • GCN: 04300
  • GPI-14 (Medi-Span): 62051025100320
  • HICL (First Databank): 012259
  • AHFS class code: 12:04.00.00
  • RxCUI (RxNorm): 997223
Why two NDCs? The FDA registers this code as 13668-103-05 — 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 → 13668-0103-05. 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

Label name DONEPEZIL HCL 10 MG TABLET Ingredient Donepezil Hcl
📖 What it is MedlinePlus · NLM

Donepezil is used to treat Alzheimer's disease (AD; a brain disease that affects memory, thinking, and behavior). Donepezil is in a class of medications called cholinesterase inhibitors. It works by increasing the amount of a certain naturally occurring substance in the brain that play a role in mental function.

Read the full MedlinePlus article ↗
📗 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 $66.95 / 500 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 Per unit Per pack Marketing startMarketing endStatus
13668-0103-05 You're viewing this 500 TABLET, FILM COATED in 1 BOTTLE — — 2011-05-31 — Active
13668-0103-10 13668-103-10 1000 TABLET, FILM COATED in 1 BOTTLE $0.0484 / ea $48.43 2011-05-31 — Active
13668-0103-26 13668-103-26 2650 TABLET, FILM COATED in 1 BOTTLE $0.0492 / ea $130.49 2011-05-31 — Active
13668-0103-30 13668-103-30 30 TABLET, FILM COATED in 1 BOTTLE $0.0484 / ea $1.45 2011-05-31 — Active
13668-0103-90 13668-103-90 Main listing 90 TABLET, FILM COATED in 1 BOTTLE $0.0484 / ea $4.36 2011-05-31 — Active

You're viewing one of 5 pack sizes for this product.

This pack shows little to no recent Medicaid volume — the 90 tablets pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This is a 500-count package — 500 tablet, film coated in 1 bottle.
How does this package differ from NDC 13668-0103-30?
Both are Donepezil Hydrochloride 10 mg Tablet, Film Coated — the drug itself is identical. This page's package is the 500-count one, while NDC 13668-0103-30 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.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

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 mgthis 13668-0103-05 Torrent 500 tablets — AB FDA listed —
donepezil hydrochloride 10 mg 29300-0249-01 Unichem 100 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

🏛️
2011
On the market since
May 2011
📍
2026
Currently FDA-listed
15 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
Imprint10
Size9 mm
ScoringNot scored
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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII 0WZ8WG20P6
    Hypromellose 2910 is a plant-based cellulose derivative that acts as a thickener, binder, and film-coating agent. It helps control how quickly the medicine dissolves and protects the tablet or capsule from moisture and light.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 30IQX730WE
    Polyethylene glycol 6000 is a synthetic polymer made from ethylene glycol units. It acts as a binder, filler, and solubilizer in medicines to help hold ingredients together, add bulk, and improve how well active drugs dissolve and absorb.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

10 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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

LabelerTorrent Pharmaceuticals Limited
Application holderTORRENT PHARMACEUTICALS LTD
FDA applicationANDA090686 (ANDA)
Labeler code13668
First marketedMay 2011
Product typeHuman Prescription Drug
Portfolio182 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. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). 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 🤒 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 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 61 words ▾

1 INDICATIONS AND USAGE Donepezil hydrochloride tablets are 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 Donepezil hydrochloride tablets are 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 188 words ▾

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 once daily ( 2.2 )

2.1Dosing in Mild to Moderate Alzheimer’s Disease The recommended starting dosage of donepezil hydrochloride tablets is 5 mg administered once per day in the evening, just prior to retiring. The maximum recommended dosage of donepezil hydrochloride tablets 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 tablets is 5 mg administered once per day in the evening, just prior to retiring. 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.

2.3Administration Information Donepezil hydrochloride tablets should be taken in the evening, just prior to retiring. Donepezil hydrochloride tablets can be taken with or without food.

💊 Dosage Forms and Strengths 79 words ▾

3 DOSAGE FORMS AND STRENGTHS Tablets: 5 mg and 10 mg (3) 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 to off white, circular, biconvex, film coated tablets debossed with '5' on one side and plain on other side. The 10 mg tablets are peach colored, circular, biconvex, film coated tablets debossed with '10' on one side and plain on other side.

⛔ Contraindications 31 words ▾

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

⚠️ Warnings and Cautions ~2 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 atrioventricular nodes manifesting as bradycardia or heart block ( 5.2 ) Donepezil hydrochloride tablets 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 ) 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 tablets.

5.3Nausea and Vomiting Donepezil hydrochloride tablets, as a predictable consequence of their pharmacological properties, have 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. Although in most cases, these effects have been transient, sometimes lasting one to three weeks, and have resolved during continued use of donepezil hydrochloride tablets, 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 tablets 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.

5.6Genitourinary Conditions Although not observed in clinical trials of donepezil hydrochloride tablets, cholinomimetics may cause bladder outflow obstruction.

5.7Neurological Conditions: Seizures Cholinomimetics are believed to have some potential to cause generalized convulsions. However, seizure activity also may be a manifestation of Alzheimer’s disease.

5.8Pulmonary Conditions Because of their cholinomimetic actions, cholinesterase inhibitors should be prescribed with care to patients with a history of asthma or obstructive pulmonary disease.

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS Most common adverse reactions in clinical studies of donepezil hydrochloride tablets are nausea, diarrhea, insomnia, vomiting, muscle cramps, fatigue, and anorexia ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Torrent Pharma Inc. at 1-800-912-9561 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 )] 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 tablets have been administered to over 1,700 individuals during clinical trials worldwide. Approximately 1,200 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 tablets due to adverse reactions for the donepezil hydrochloride tablets 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/dayDonepezil Hydrochloride Tablets (n=350)% 10 mg/day Donepezil Hydrochloride Tablets (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 tablet'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 tablets 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 Placebo (n=315) % 5 m… [Excerpted — this section continues on DailyMed.]

🔄 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 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 16 times the maximum recommended human dose [MRHD] of 10 mg/day on a mg/m 2 basis) and 10 mg/kg/day (approximately 20 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 3 times 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 and any potential adverse effects on the breastfed infant from donepezil 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 tablets 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 events reported by patient groups ≥65 years old and <65 years old.

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary There are no adequate data on the developmental risks associated with the use of donepezil 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 16 times the maximum recommended human dose [MRHD] of 10 mg/day on a mg/m 2 basis) and 10 mg/kg/day (approximately 20 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 3 times 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 94 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 tablets 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 events reported by patient groups ≥65 years old and <65 years old.

🆘 Overdosage 196 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 tablets 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 to 10 mg given once daily. The rate and extent of absorption of donepezil hydrochloride tablets are not influenced by food. Donepezil hydrochloride ODT 5 mg and 10 mg are bioequivalent to donepezil hydrochloride 5 mg and 10 mg tablets, respectively. The elimination half life of donepezil is about 70 hours, and the mean apparent plasma clearance (Cl/F) is 0.13 to

0.19L/hr/kg. Following multiple dose administration, donepezil accumulates in plasma by 4 to 7 fold, and steady state is reached within 15 days. The steady state volume of distribution is 12 to 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 to 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 17% decrease in clearance, while 40-year old subjects have a 33% increase in clearance. The effect of age on donepezil clearance may not be clinically significant. Gender and Race No specific pharmacokinetic study was conducted to investigate the effects of gender and race on the disposition of donepezil hydrochloride.

However, retrospective pharmacokinetic analysis and population pharmacokinetic analysis of plasma donepezil concentrations measured in patients with Alzheimer's disease indicates that gender and race (Japanese and Caucasians) did not affect the clearance of donepezil hydrochloride to an important degree. Body Weight There was a relationship noted bet… [Excerpted — this section continues on DailyMed.]

🧬 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 134 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1Donepezil Hydrochloride Tablets Donepezil hydrochloride tablets, USP 5 mg are white to off white, circular, biconvex, film coated tablets debossed with ‘5’ on one side and plain on other side. Bottles of 30 NDC 13668-102-30 Bottles of 90 NDC 13668-102-90 Bottles of 500 NDC 13668-102-05 Bottles of 1000 NDC 13668-102-10 Bottles of 4000 NDC 13668-102-40 Donepezil hydrochloride tablets, USP 10 mg are peach colored, circular, biconvex, film coated tablets debossed with ‘10’ on one side and plain on other side. Bottles of 30 NDC 13668-103-30 Bottles of 90 NDC 13668-103-90 Bottles of 500 NDC 13668-103-05 Bottles of 1000 NDC 13668-103-10 Bottles of 2650 NDC 13668-103-26 Storage: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [see USP Controlled Room Temperature].

📋 Description 161 words ▾

11 DESCRIPTION Donepezil hydrochloride USP 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 an empirical formula of C 24 H 29 NO 3 HCl and a molecular weight of 415.96.

Donepezil hydrochloride, USP 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 or 10 mg of donepezil hydrochloride, USP. Inactive ingredients in 5 mg and 10 mg tablets are lactose monohydrate, magnesium stearate, maize starch ( Zea mays ) and microcrystalline cellulose.

The film coating contains hypromellose, polyethylene glycol, talc and titanium dioxide. Additionally, the 10 mg tablet contains ferric oxide red and ferric oxide yellow as coloring agents. str

💬 Information for Patients 101 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 tablets only once per day, as prescribed. Instruct patients and caregivers that donepezil hydrochloride tablets can be taken with or without food.

Advise patients and caregivers that donepezil hydrochloride tablets 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. Manufactured by: Torrent Pharmaceuticals LTD., India.

Manufactured for: Torrent Pharma INC., Basking Ridge, NJ 07920 8106601 Revised: January 2026 logo

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Pharmacokinetics of donepezil are linear over a dose range of 1 to 10 mg given once daily. The rate and extent of absorption of donepezil hydrochloride tablets are not influenced by food. Donepezil hydrochloride ODT 5 mg and 10 mg are bioequivalent to donepezil hydrochloride 5 mg and 10 mg tablets, respectively. The elimination half life of donepezil is about 70 hours, and the mean apparent plasma clearance (Cl/F) is 0.13 to

0.19L/hr/kg. Following multiple dose administration, donepezil accumulates in plasma by 4 to 7 fold, and steady state is reached within 15 days. The steady state volume of distribution is 12 to 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 to 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 17% decrease in clearance, while 40-year old subjects have a 33% increase in clearance. The effect of age on donepezil clearance may not be clinically significant. Gender and Race No specific pharmacokinetic study was conducted to investigate the effects of gender and race on the disposition of donepezil hydrochloride.

However, retrospective pharmacokinetic analysis and population pharmacokinetic analysis of plasma donepezil concentrations measured in patients with Alzheimer's disease indicates that gender and race (Japanese and Caucasians) did not affect the clearance of donepezil hydrochloride to an important degree. Body Weight There was a relationship noted between body weight and clearance. Over the range of body weight from 50 kg to 110 kg, clearance increased from

7.77 L/h to

14.04L/h, with a value of 10 L/hr for 70 kg individuals. Drug Interactions Effect of Donepezil Hydrochloride Tablets on the Metabolism of Other Drugs No in vivo clinical trials have investigated the effect of donepezil hydrochloride tablets on the clearance of drugs metabolized by CYP 3A4 (e.g. cisapride, terfenadine) or by CYP 2D6 (e.g. imipramine). However, in vitro studies show a low rate of binding to these enzymes (mean K i abo… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Mild to Moderate Alzheimer’s Disease The effectiveness of donepezil hydrochloride tablets as a treatment for mild to moderate Alzheimer's disease is demonstrated by the results of two randomized, double-blind, placebo-controlled clinical investigations in patients with Alzheimer's disease (diagnosed by NINCDS and DSM III-R criteria, Mini-Mental State Examination ≥10 and ≤26 and Clinical Dementia Rating of 1 or 2). The mean age of patients participating in donepezil hydrochloride tablets trials was 73 years with a range of 50 to 94.

Approximately 62% of patients were women and 38% were men. The racial distribution was white 95%, black 3% and other races 2%. The higher dose of 10 mg did not provide a statistically significantly greater clinical benefit than 5 mg.

There is a suggestion, however, based upon order of group mean scores and dose trend analyses of data from these clinical trials, that a daily dose of 10 mg of donepezil hydrochloride tablets might provide additional benefit for some patients. Accordingly, whether or not to employ a dose of 10 mg is a matter of prescriber and patient preference. Study Outcome Measures In each study, the effectiveness of treatment with donepezil hydrochloride tablets was evaluated using a dual outcome assessment strategy.

The ability of donepezil hydrochloride tablets to improve cognitive performance was assessed with the cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-cog), a multi-item instrument that has been extensively validated in longitudinal cohorts of Alzheimer's disease patients. The ADAS-cog examines selected aspects of cognitive performance including elements of memory, orientation, attention, reasoning, language and praxis. The ADAS-cog scoring range is from 0 to 70, with higher scores indicating greater cognitive impairment.

Elderly normal adults may score as low as 0 or 1, but it is not unusual for non-demented adults to score slightly higher. The patients recruited as participants in each study had mean scores on the ADAS-cog of approximately 26 points, with a range from 4 to 61. Experience based on longitudinal studies of ambulatory patients with mild to moderate Alzheimer's disease suggest that scores on the ADAS-cog increase (worsen) by 6 to 12 points per year.

However, smaller changes may be seen in patients with very mild or very advanced disease since the ADAS-cog is not uniformly sensitive to change over the course of the disease. The annualized rate of decline in the placebo patients participating in donepezil hydrochloride tablets trials was approximately 2 to 4 points per year. The ability of donepezil hydrochloride tablets to produce an overall clinical effect was assessed using a Clinician's Interview-Based Impression of Change that required the use of caregiver information, the CIBIC-plus.

The CIBIC-plus is not a single instrument and is not a standardized instrument like the ADAS-cog. Clinical trials for investigational drugs have used a variety of CIBIC formats, each different in terms of depth and structure. As such, results from a CIBIC-plus reflect clinical experience from the trial or trials in which it was used and cannot be compared directly with the results of CIBIC-plus evaluations from other clinical trials.

The CIBIC-plus used in donepezil hydrochloride tablets trials was a semi-structured instrument that was intended to examine four major areas of patient function: General, Cognitive, Behavioral and Activities of Daily Living. It represents the assessment of a skilled clinician based upon his/her observations at an interview with the patient, in combination with information supplied by a caregiver familiar with the behavior of the patient over the interval rated. The CIBIC-plus is scored as a seven-point categorical rating, ranging from a score of 1, indicating "markedly improved," to a score of 4, indicating "no change" to a score of 7, indicating "markedly worse." The CIBIC-plus has not been systema… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 207 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No evidence of carcinogenic potential was obtained in an 88-week carcinogenicity study of donepezil conducted in mice at oral doses up to 180 mg/kg/day (approximately 86 times the maximum recommended human dose [MRHD] of 10 mg/day on a mg/m 2 basis), or in a 104-week carcinogenicity study in rats at oral doses up to 30 mg/kg/day (approximately 29 times the MRHD on a mg/m 2 basis). Donepezil was negative in a battery of genotoxicity assays ( in vitro bacterial reverse mutation, in vitro mouse lymphoma tk , in vitro chromosomal aberration, and in vivo mouse micronucleus).

Donepezil had no effect on fertility in rats at oral doses up to 10 mg/kg/day (approximately 10 times the MRHD on a mg/m 2 basis) when administered to males and females prior to and during mating and continuing in females through implantation.

13.2Animal Toxicology and/or Pharmacology In an acute dose neurotoxicity study in female rats, oral administration of donepezil and memantine in combination resulted in increased incidence, severity, and distribution of neurodegeneration compared with memantine alone. The no-effect levels of the combination were associated with clinically relevant plasma donepezil and memantine levels. The relevance of this finding to humans is unknown.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 144 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No evidence of carcinogenic potential was obtained in an 88-week carcinogenicity study of donepezil conducted in mice at oral doses up to 180 mg/kg/day (approximately 86 times the maximum recommended human dose [MRHD] of 10 mg/day on a mg/m 2 basis), or in a 104-week carcinogenicity study in rats at oral doses up to 30 mg/kg/day (approximately 29 times the MRHD on a mg/m 2 basis). Donepezil was negative in a battery of genotoxicity assays ( in vitro bacterial reverse mutation, in vitro mouse lymphoma tk , in vitro chromosomal aberration, and in vivo mouse micronucleus).

Donepezil had no effect on fertility in rats at oral doses up to 10 mg/kg/day (approximately 10 times the MRHD on a mg/m 2 basis) when administered to males and females prior to and during mating and continuing in females through implantation.

📄 Patient Package Insert ~3 min read ▾

DONEPEZIL HYDROCHLORIDE TABLETS PATIENT PACKAGE INSERT Donepezil Hydrochloride (doe-NEP-e-zil HYE-droe-KLOR-ide) Tablets, USP Rx Only Tablets: 5 mg and 10 mg Read this Patient Information that comes with donepezil hydrochloride tablets before you start taking them 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 are donepezil hydrochloride tablets? Donepezil hydrochloride tablets come as donepezil hydrochloride film-coated tablets in dosage strengths of 5 mg and 10 mg.

Donepezil hydrochloride tablets are a prescription medicine to treat mild, moderate and severe Alzheimer’s disease. Donepezil hydrochloride tablets can help with mental function and with doing daily tasks. Donepezil hydrochloride tablet 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 tablet does not cure Alzheimer’s disease. All patients with Alzheimer’s disease get worse over time, even if they take donepezil hydrochloride tablets. Donepezil hydrochloride tablets have not been approved as a treatment for any medical condition in children.

Who should not take donepezil hydrochloride tablets? Do not take donepezil hydrochloride tablets if you are allergic to any of the ingredients in donepezil hydrochloride tablets 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. What should I tell my doctor before taking donepezil hydrochloride tablets? 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 tablets 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 tablets. Tell the doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal products.

Donepezil hydrochloride tablets 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 tablets together may make you more likely to get stomach ulcers. Donepezil hydrochloride tablets taken with certain medicines used for anesthesia may cause side effects.

Tell the responsible doctor or dentist that you take donepezil hydrochloride tablets 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 tablets? Take donepezil hydrochloride tablets exactly as prescribed by the doctor.

Do not stop donepezil hydrochloride tablets or change the dose yourself. Talk with your doctor first. Take donepezil hydrochloride tablets one time each day.

Donepezil hydrochloride tablets can be taken with or without food. If you miss a dose of donepezil hydrochloride tablets, just wait. Take only the next dose at the usual time.

Do not take 2 doses at the same time. If donepezil hydrochloride tablets are missed for 7 days or more, talk with you… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 45 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Donepezil Hydrochloride Tablets USP, 5 mg - Indrad Donepezil Hydrochloride Tablets USP, 5 mg - dahej 5 mg 5mg-dahej

Donepezil Hydrochloride Tablets USP, 10 mg - Indrad Donepezil Hydrochloride Tablets USP, 10 mg - Dahej 10 mg 10 mg - Dahej

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

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
90 tablets13668-0103-90 2,846 Rx · $27,946
1000 tablets13668-0103-10 167 Rx · $1,965
30 tablets13668-0103-30 41 Rx · $473
500 tablets this page13668-0103-05 No Medicaid data
2650 tablets13668-0103-26 No Medicaid data
Drug total (last 4 qtrs): 3,054 Rx · 166,593 units · $30,384 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“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 Torrent Pharmaceuticals Limited. 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 4 other package presentations of this same product, including 30 tablets (13668-0103-30), 90 tablets (13668-0103-90), 1000 tablets (13668-0103-10). 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?
Torrent Pharmaceuticals Limited 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.
← 13668-0102-05 · Torrent 13668-0104-01 · Torrent →
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.