Donepezil Hydrochloride Tablet, Orally Disintegrating
Product Images NDC 33342-030

Product Visual Gallery

This gallery contains 24 technical images submitted to the FDA as part of the official labeling for Donepezil Hydrochloride (NDC 33342-030). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Macleods Pharmaceuticals Limited, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Str (Donepezil Str)

Chemical structure of Donepezil Hydrochloride showing the molecular framework including methoxy groups, a piperidine ring, and phenyl substituent with a hydrochloride component.*

FDA Label Image

Fig-1 (Donepezil Figure 1)

A line graph depicting the ADAS-cog mean change from baseline over 24 weeks for Donepezil Hydrochloride at 10 mg/day, 5 mg/day, and placebo groups. The graph shows improved cognitive scores (clinical improvement) for the Donepezil groups compared to clinical decline in the placebo group over the treatment period.*

FDA Label Image

Fig-2 (Donepezil Figure 2)

A cumulative percentage graph showing patient response to Donepezil Hydrochloride 5 mg and 10 mg versus placebo based on change from baseline in ADAS-cog scores. The x-axis represents change from baseline, and the y-axis shows cumulative patient percentage, with key points at 7, 4, and no change. Data indicate greater percentages of patients improving with Donepezil compared to placebo.*

FDA Label Image

Fig-3 (Donepezil Figure 3)

A bar graph comparing the percentage of patients by CIBIC-plus rating categories for Donepezil Hydrochloride 10 mg/day, 5 mg/day, and placebo groups. The x-axis shows categories from markedly improved to markedly worse, and the y-axis shows percentage of patients up to 50%. Bars depict patient distribution across ratings for each treatment group.*

FDA Label Image

Fig-4 (Donepezil Figure 4)

A line graph showing ADAS-cog change from baseline (mean ±SE) over 15 weeks of drug treatment for Donepezil Hydrochloride 10 mg/day, 5 mg/day, and placebo groups. The y-axis ranges from -4 to 3, with negative values indicating clinical improvement and positive values clinical decline. The graph illustrates cognitive change trends among the three groups over time, with Donepezil 10 mg/day showing the greatest improvement.*

FDA Label Image

Fig-5 (Donepezil Figure 5)

A cumulative percentage plot showing the change from baseline in ADAS-cog scores for patients treated with Donepezil Hydrochloride 10 mg/day, 5 mg/day, and placebo. The x-axis represents the change from baseline, and the y-axis shows the cumulative percentage of patients. The graph includes vertical lines at -7 points, -4 points, and no change, with a table summarizing percent patients at different change thresholds for each treatment group.*

FDA Label Image

Fig-6 (Donepezil Figure 6)

A bar chart showing the distribution of CIBIC-plus ratings among patients treated with Donepezil Hydrochloride 10 mg/day, 5 mg/day, and placebo. The vertical axis represents the percentage of patients, while the horizontal axis shows categories from 'Markedly Improved' to 'Markedly Worse'. Data is compared across the three groups using different colored bars for each rating category.*

FDA Label Image

Fig-7 (Donepezil Figure 7)

A line graph showing the SIB (Severe Impairment Battery) change from baseline mean with standard error over months of drug treatment (0, 3, 6 months). It compares Donepezil Hydrochloride 10 mg/day (solid circle line) and placebo (open square line). The vertical axis indicates clinical improvement above baseline and clinical decline below baseline.*

FDA Label Image

Fig-8 (Donepezil Figure 8)

A cumulative percentage graph showing patient response comparing Donepezil Hydrochloride 10 mg/day to placebo based on SIB (Severe Impairment Battery) change from baseline. The x-axis represents SIB change from baseline, and the y-axis shows cumulative percentage of patients. Filled circles represent Donepezil 10 mg/day, and open squares represent placebo.*

FDA Label Image

Fig-9 (Donepezil Figure 9)

A line graph depicting the mean change from baseline in ADCS-ADL scores over 6 months of drug treatment, comparing Donepezil Hydrochloride 10 mg/day with placebo. The y-axis shows change from baseline with clinical improvement at the top and clinical decline at the bottom. The x-axis represents months of treatment at 0, 3, and 6 months.*

FDA Label Image

Fig-10 (Donepezil Figure 10)

A cumulative percentage curve graph comparing Donepezil Hydrochloride 10 mg/day versus placebo based on ADCS-ADL change from baseline. The x-axis represents ADCS-ADL change scores, and the y-axis shows the cumulative percentage of patients, illustrating response distribution for both groups.*

FDA Label Image

Fig-11 (Donepezil Figure 11)

A line graph showing the SIB (Severe Impairment Battery) change from baseline over 24 weeks of drug treatment. It compares Donepezil Hydrochloride 23 mg/day and 10 mg/day doses. The vertical axis represents SIB change from baseline (mean ± SE) ranging from -3 to 5, indicating clinical decline to clinical improvement. The horizontal axis indicates weeks of treatment from 0 to 24. Both doses show improvement initially, with the 23 mg/day dose showing greater improvement sustained over time.*

FDA Label Image

Fig-12 (Donepezil Figure 12)

A cumulative percentage of patients chart comparing Donepezil Hydrochloride 23 mg/day and 10 mg/day. The X-axis represents SIB (Severe Impairment Battery) change from baseline, while the Y-axis shows the cumulative percentage of patients, illustrating patient response distribution for each dosage.*

FDA Label Image

Fig-13 (Donepezil Figure 13)

Bar chart comparing the percentage of patients by CIBIC-plus Rating for Donepezil Hydrochloride 23 mg/day and 10 mg/day dosages. The chart shows categories from Markedly Improved to Markedly Worse with corresponding patient percentages on the vertical axis, illustrating patient response distribution for both dose groups.*

FDA Label Image

Donepezil-hcl-5mg-30s.jpg (Donepezil HCl 5mg 30s)

Donepezil Hydrochloride Tablets USP 5 mg label from Macleods Pharmaceuticals Limited. The label states each film-coated tablet contains 5 mg Donepezil hydrochloride. Packaging includes 30 tablets. Manufacturer information lists Macleods Pharma USA, Inc. and Macleods Pharmaceuticals Ltd. Storage instructions specify 20° to 25°C (68° to 77°F).*

FDA Label Image

Donepezil-hcl-5mg-90s.jpg (Donepezil HCl 5mg 90s)

Donepezil Hydrochloride Tablets, USP 5 mg film-coated, package label showing quantity of 90 tablets. Manufactured for Macleods Pharma USA, Inc. and by Macleods Pharmaceuticals Ltd. Dosage instructions refer to prescribing information. Storage instructions specify 20° to 25°C controlled room temperature. The label includes barcodes and a placeholder for an imprint area.*

FDA Label Image

Donepezil-hcl-5mg-500s.jpg (Donepezil HCl 5mg 500s)

Donepezil Hydrochloride Tablets USP 5 mg label by Macleods Pharmaceuticals Limited. The label indicates 500 film-coated tablets per container, with storage instructions at 20 to 25°C. It includes directions for pharmacists to dispense a patient information leaflet and notes dosage information is in the prescribing information. Manufactured by Macleods Pharmaceuticals Ltd., India, and labeled for Macleods Pharma USA Inc.*

FDA Label Image

Donepezil-hcl-tablet-10mg-500s.jpg (Donepezil HCl Tablet 10mg 500s)

Label for Donepezil Hydrochloride Tablets, USP 10 mg by Macleods Pharmaceuticals Limited. The label includes storage instructions at 20° to 25°C, dispensing guidance for pharmacists, and manufacturer information for Macleods Pharma USA and Macleods Pharmaceuticals Ltd. The package count is 500 tablets.*

FDA Label Image

Donepezil-23mg-30s.jpg (Donepezil 23mg 30s)

Donepezil Hydrochloride Tablets 23 mg film-coated tablets label. The label includes the strength, quantity of 30 tablets, storage instructions, manufacturer information for Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, India, and Macleods Pharma USA, Inc., Plainsboro, NJ. It also notes the product is Rx only and provides usual dosage directions to consult prescribing information.*

FDA Label Image

Donepezil-23mg-90s.jpg (Donepezil 23mg 90s)

Label for Donepezil Hydrochloride tablets 23 mg by Macleods Pharmaceuticals Limited. The label indicates the product contains 23 mg donepezil hydrochloride per film-coated tablet, with a quantity of 90 tablets. It includes storage instructions, manufacturer details, and a note to dispense the patient information leaflet. The label shows the NDC 33342-061-10 and mentions the product is Rx only.*

FDA Label Image

Donepezil-odt-5mg-30s.jpg (Donepezil Odt 5mg 30s)

Donepezil Hydrochloride Orally Disintegrating Tablets USP 5 mg label by Macleods Pharmaceuticals Limited. The label includes instructions for the pharmacist to dispense the patient information leaflet and storage guidelines at 20°-25°C. The package contains 30 tablets and shows manufacturing details for Macleods Pharma USA, Inc. and Macleods Pharmaceuticals Ltd. in India, along with barcodes and spaces for batch number and expiration date.*

FDA Label Image

Donepezil-odt-10mg-30s.jpg (Donepezil Odt 10mg 30s)

Donepezil Hydrochloride Orally Disintegrating Tablets USP 10 mg label from Macleods Pharmaceuticals Limited. The label specifies 30 tablets, including storage instructions at 20°-25°C and a note to dispense the patient information leaflet. Manufactured for Macleods Pharma USA, Inc. in New Jersey and by Macleods Pharmaceuticals Ltd. in Baddi, Himachal Pradesh, India.*

FDA Label Image

Donepezil-odt-5-mg-4x7-28s.jpg (Donepezil Odt 5 mg 4x7 28s)

Donepezil Hydrochloride Orally Disintegrating Tablets USP 5 mg in a carton label for 28 tablets (4 x 7 unit-dose tablets). The label shows Macleods Pharmaceuticals Limited as the manufacturer, marketed by Macleods Pharma USA, Inc. Directions note to dispense the patient information leaflet with the product. Storage instructions specify 20°-25°C. Barcode and NDC 33342-029-60 are visible.*

FDA Label Image

Donepezil-odt-10-mg-4x7-28s.jpg (Donepezil Odt 10 mg 4x7 28s)

Donepezil Hydrochloride Orally Disintegrating Tablets, USP, 10 mg. The label shows a carton containing 28 tablets (4 x 7 unit-dose tablets) manufactured by Macleods Pharmaceuticals Ltd and labeled for Macleods Pharma USA, Inc. The label includes dosing instructions to refer to the prescribing information and storage conditions of 20°-25°C (68°-77°F). A barcode and product identification details are also visible.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.