Donepezil Hydrochloride Tablet, Film Coated
Product Images NDC 43547-878

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Donepezil Hydrochloride (NDC 43547-878). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Solco Healthcare Us, Llc, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

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Structural Formula (41d7651e B91a 4118 8719 Bf2f663d82a2 01)

Chemical structure of donepezil hydrochloride, showing the molecular framework including aromatic rings, a piperidine ring, and functional groups with a hydrochloride salt.*

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Figure 1 (41d7651e B91a 4118 8719 Bf2f663d82a2 02)

A line graph depicting ADAS-cog (Alzheimer's Disease Assessment Scale-cognitive subscale) change from baseline over 30 weeks of drug treatment, comparing donepezil hydrochloride 10 mg/day, 5 mg/day, and placebo. The y-axis shows cognitive change with clinical improvement at the top and decline at the bottom. Both donepezil doses show improvement, while placebo shows decline over time.*

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Figure 2 (41d7651e B91a 4118 8719 Bf2f663d82a2 03)

A cumulative percentage of patients plot showing change from baseline on the ADAS-cog scale over a range of -15 to +15. The graph compares three groups: donepezil hydrochloride 10 mg/day, donepezil hydrochloride 5 mg/day, and placebo, with lines and markers distinguishing each group. A table inset displays percentages of patients with changes of -7, -4, and no change for each treatment group.*

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Figure 3 (41d7651e B91a 4118 8719 Bf2f663d82a2 04)

Bar chart showing the percentage of patients by CIBIC-plus rating categories (ranging from markedly improved to markedly worse) comparing donepezil hydrochloride 10 mg/day, 5 mg/day, and placebo groups. The chart illustrates patient responses to these treatments across different improvement and worsening levels.*

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Figure 4 (41d7651e B91a 4118 8719 Bf2f663d82a2 05)

A line graph showing ADAS-cog (Alzheimer's Disease Assessment Scale-cognitive subscale) change from baseline over 15 weeks of drug treatment. It compares donepezil hydrochloride 10 mg/day, 5 mg/day, and placebo groups, illustrating cognitive changes with clinical improvement and decline indicated on the y-axis.*

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Figure 5 (41d7651e B91a 4118 8719 Bf2f663d82a2 06)

A cumulative percentage plot depicting the change from baseline in ADAS-cog scores among patients treated with donepezil hydrochloride 5 mg/day, 10 mg/day, and placebo. The x-axis shows the change from baseline, with markers indicating 7 points, 4 points, and no change. The y-axis represents the cumulative percentage of patients. The graph includes a table summarizing the percent of patients experiencing a 7-point improvement, no change, or other results for each treatment group.*

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Figure 6 (41d7651e B91a 4118 8719 Bf2f663d82a2 07)

A bar chart depicting the percentage of patients categorized by CIBIC-plus Rating groups following treatment with Aricept 10 mg/day, Aricept 5 mg/day, and placebo. The CIBIC-plus Rating groups range from Markedly Improved to Markedly Worse, showing variations in patient response distributions among the three groups.*

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Figure 7 (41d7651e B91a 4118 8719 Bf2f663d82a2 08)

A line graph depicting SIB change from baseline over 6 months of drug treatment comparing donepezil hydrochloride 10 mg/day to placebo. The vertical axis shows mean change with standard error, indicating clinical improvement or decline, and the horizontal axis shows months of treatment.*

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Figure 8 (41d7651e B91a 4118 8719 Bf2f663d82a2 09)

A cumulative percentage graph comparing the effects of donepezil hydrochloride 10 mg/day and a placebo on SIB score change from baseline in patients. The x-axis represents SIB change from baseline and the y-axis shows cumulative percentage of patients, with donepezil data points indicated by solid circles and placebo by open squares.*

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Figure 9 (41d7651e B91a 4118 8719 Bf2f663d82a2 10)

A line graph depicting the mean change from baseline in the ADCS-ADL score over 6 months of drug treatment. It compares donepezil hydrochloride 10 mg/day and placebo, showing clinical improvement above baseline and clinical decline below baseline on the vertical axis. Data points at 3 and 6 months illustrate a trend of less decline for donepezil hydrochloride compared to placebo.*

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Figure 10 (41d7651e B91a 4118 8719 Bf2f663d82a2 11)

A cumulative percentage plot comparing donepezil hydrochloride 10 mg/day with placebo. The x-axis shows ADCS-ADL change from baseline, ranging from 20 to -20, and the y-axis shows the cumulative percentage of patients from 0% to 100%. The graph plots two curves: one for donepezil hydrochloride (solid circles) and one for placebo (open squares). A vertical dashed line marks the baseline at 0 change.*

FDA Label Image

5 mg 30 Tablets (Image 01)

Donepezil HCl Tablets USP 5 mg film-coated tablets packaging label. The label shows the product name, strength, dosage form, and quantity of 30 tablets. It includes storage instructions, manufacturer information (Prinston Laboratories), and distributor (Solco Healthcare US, LLC) details. The label also displays the NDC 43547-878-03 and a barcode.*

FDA Label Image

10 mg 30 Tablets (Image 02)

Label for Donepezil HCl Tablets, USP 10 mg, film-coated oral tablets. The label includes the NDC 43547-879-03, prescribing information note, and states the package contains 30 tablets. Manufactured by Prinston Laboratories and distributed by Solco Healthcare US, LLC. The label features a blue and gold design with a barcode on the right side.*

* 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.