Donepezil Hydrochloride Tablet, Film Coated
Product Images NDC 0904-6478

Product Visual Gallery

This gallery contains 15 technical images submitted to the FDA as part of the official labeling for Donepezil Hydrochloride (NDC 0904-6478). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Major Pharmaceuticals, 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

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Donepezil Hydrochloride 10 mg film-coated tablets by Major Pharmaceuticals. The label shows the product strength (10 mg), dosage form (tablet, film-coated), unit dose packaging with 100 tablets, and instructions for pharmacists to dispense with patient information. It includes storage and usage instructions, labeler contact information, and regulatory details.*

FDA Label Image

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Donepezil Hydrochloride 5 mg film-coated tablets label from Major Pharmaceuticals. The label indicates the dosage form as film-coated tablets, strength of 5 mg, and a unit dose packaging size of 100 tablets. It includes instructions to dispense with a patient information sheet, marked as prescription only, and contains regulatory and manufacturing information along with the labeler's contact details.*

FDA Label Image

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Chemical structure diagram of Donepezil Hydrochloride showing the molecular arrangement including piperidine ring and methoxy groups attached to the aromatic system, along with hydrochloride (HCl) salt indication.*

FDA Label Image

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A line graph showing the mean change from baseline in ADAS-cog scores over 24 weeks of treatment followed by a placebo period. The graph compares Donepezil Hydrochloride Tablets at 10 mg/day and 5 mg/day against placebo, illustrating clinical improvement and decline with labeled axes for weeks of drug treatment and score changes.*

FDA Label Image

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A cumulative percentage plot showing the change from baseline in ADAS-cog scores for Donepezil Hydrochloride Tablets 5 mg/day, 10 mg/day, and placebo. The x-axis represents change from baseline, and the y-axis represents cumulative percentage of patients. The graph includes a table summarizing the percent of patients achieving specific point changes (-7, -4, 0) in each treatment group.*

FDA Label Image

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A bar chart showing the distribution of patients by CIBIC-plus rating comparing Donepezil Hydrochloride Tablets 10 mg/day, 5 mg/day, and placebo. The x-axis lists ratings from Markedly Improved to Markedly Worse, and the y-axis shows the percentage of patients. Percentages vary among treatment groups across the seven rating categories.*

FDA Label Image

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A line graph showing changes in ADAS-cog scores from baseline over 15 weeks of drug treatment. It compares Donepezil Hydrochloride Tablets 10 mg/day, 5 mg/day, and placebo, indicating clinical improvement or decline on the vertical axis and weeks of treatment on the horizontal axis.*

FDA Label Image

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A cumulative percentage graph showing change from baseline in ADAS-cog scores for Donepezil Hydrochloride 10 mg/day, 5 mg/day, and placebo groups. The x-axis represents change from baseline, and the y-axis shows cumulative percentage of patients. The graph includes vertical markers at -7, -4, and 0 points with an inset table summarizing percentage of patients reaching those changes by treatment group.*

FDA Label Image

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A bar chart displaying the percentage of patients across different CIBIC-plus Rating categories comparing Donepezil Hydrochloride Tablets 10 mg/day, 5 mg/day, and placebo groups. The x-axis shows ratings from Markedly Improved to Markedly Worse, and the y-axis shows patient percentages up to 50%. Bars indicate distribution of patient outcomes for each treatment group.*

FDA Label Image

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A line graph showing SIB change from baseline (mean ± SE) over months of drug treatment for Donepezil Hydrochloride Tablets 10 mg/day versus placebo. The x-axis represents months of treatment (0, 3, 6), and the y-axis shows SIB change ranging from -8 to 8. Donepezil shows clinical improvement over time, while placebo shows clinical decline. Error bars are included.*

FDA Label Image

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A cumulative percentage of patients chart comparing Donepezil Hydrochloride Tablets 10 mg/day to placebo. The x-axis represents the SIB (Severe Impairment Battery) change from baseline, ranging from +30 to -75, while the y-axis shows the cumulative percentage of patients from 0 to 100%. The chart features two curves: one with black circles representing Donepezil Hydrochloride and another with open squares representing placebo, illustrating the distribution of patient responses.*

FDA Label Image

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A line graph depicting the change from baseline in the ADCS-ADL-Severe Score over 6 months for patients treated with Donepezil Hydrochloride Tablets 10 mg/day and placebo. The x-axis shows months of drug treatment (0, 3, 6), and the y-axis shows the mean change from baseline (±SE). The graph illustrates a decline over time, with the Donepezil group showing less decline than the placebo group.*

FDA Label Image

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A cumulative distribution graph comparing Donepezil Hydrochloride tablets 10 mg/day versus placebo. The x-axis represents ADCS-ADL change from baseline, and the y-axis shows the cumulative percentage of patients. The graph displays two lines: one with black circles for Donepezil Hydrochloride 10 mg/day and one with open squares for placebo, illustrating patient response differences over the range of change values.*

FDA Label Image

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FDA Label Image

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* 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.