Donepezil Hydrochloride Tablet, Film Coated
Product Images NDC 55111-302

Product Visual Gallery

This gallery contains 15 technical images submitted to the FDA as part of the official labeling for Donepezil Hydrochloride (NDC 55111-302). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Dr. Reddys Laboratories 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

Container (Container)

Label for Donepezil Hydrochloride Tablets, USP 23 mg by Dr. Reddys Laboratories Limited. The film-coated oral tablet package contains 30 tablets. The label includes dosage strength, manufacturer information, a QR code, barcode, and storage instructions.*

FDA Label Image

Graph1 (Graph1)

A line graph showing ADAS-cog mean change from baseline over 30 weeks of drug treatment for Donepezil hydrochloride 10 mg/day, 5 mg/day, and placebo. The y-axis represents cognitive change with clinical improvement above baseline and clinical decline below. The graph illustrates drug treatment weeks on the x-axis and shows Donepezil groups maintaining improvement, while placebo shows decline after week 6.*

FDA Label Image

Graph10 (Graph10)

A cumulative percentage of patients graph comparing Donepezil 10 mg/day versus placebo. The x-axis shows ADCS-ADL change from baseline ranging approximately from -20 to 20, and the y-axis shows cumulative percentage of patients from 0 to 100%. The graph uses different markers to represent Donepezil and placebo groups with plotted curves illustrating the distribution of patient responses.*

FDA Label Image

Graph11 (Graph11)

A line graph showing the SIB (Severe Impairment Battery) change from baseline (LS mean ±SE) over 24 weeks of drug treatment for Donepezil 23 mg/day and Donepezil 10 mg/day. The graph indicates clinical improvement above baseline and clinical decline below baseline, comparing the two dose groups over time.*

FDA Label Image

Graph12 (Graph12)

A cumulative percentage graph comparing patients taking Donepezil hydrochloride 23 mg/day and 10 mg/day. The x-axis shows SIB (Severe Impairment Battery) change from baseline, ranging from 50 to -60, while the y-axis represents the cumulative percentage of patients from 0% to 100%. The graph illustrates patient response distributions for two different dosages of Donepezil hydrochloride.*

FDA Label Image

Graph13 (Graph13)

A bar chart comparing the percentage of patients by CIBIC-plus rating categories for Donepezil 23 mg/day and Donepezil 10 mg/day. Categories include Markedly Improved, Moderately Improved, Minimally Improved, No Change, Minimally Worse, Moderately Worse, and Markedly Worse. The chart visually contrasts patient response distributions between the two dosage groups.*

FDA Label Image

Graph2 (Graph2)

A cumulative percentage plot showing patient response over change from baseline in ADAS-cog scores for Donepezil hydrochloride at 5 mg/day and 10 mg/day doses compared to placebo. The chart includes vertical markers for 7 points, 4 points, and no change, with a table summarizing treatment group percentages for these change levels.*

FDA Label Image

Graph3 (Graph3)

A bar chart showing the percentage of patients by CIBIC-plus rating categories for Donepezil 10 mg/day, Donepezil 5 mg/day, and placebo groups. The categories range from markedly improved to markedly worse, illustrating patient outcomes for each treatment group.*

FDA Label Image

Graph4 (Graph4)

A line graph depicting ADAS-cog mean change from baseline over 15 weeks of drug treatment. It compares Donepezil 10 mg/day, Donepezil 5 mg/day, and placebo groups, showing clinical improvement above baseline and clinical decline below, with error bars indicating standard error.*

FDA Label Image

Graph5 (Graph5)

A cumulative percentage chart showing patient response based on change from baseline in ADAS-cog scores. The graph compares three groups: Donepezil 10 mg/day, Donepezil 5 mg/day, and placebo. The x-axis represents change from baseline, and the y-axis shows cumulative percentage of patients. Thresholds for 7 points improvement, 4 points improvement, and no change are marked, with corresponding treatment group data included in a table.*

FDA Label Image

Graph6 (Graph6)

A bar chart showing the percentage of patients categorized by CIBIC-plus Rating across three groups: Donepezil 10 mg/day, Donepezil 5 mg/day, and Placebo. The ratings range from Markedly Improved to Markedly Worse, depicting how patients' conditions changed under different treatments.*

FDA Label Image

Graph7 (Graph7)

A line graph depicting SIB (Severe Impairment Battery) change from baseline over 6 months of drug treatment comparing Donepezil 10 mg/day and placebo. The y-axis shows mean change with standard error, where positive values indicate clinical improvement and negative values clinical decline. Donepezil shows increasing improvement at month 3 sustained to month 6, while placebo shows slight decline.*

FDA Label Image

Graph8 (Graph8)

A cumulative percentage of patients line graph showing SIB change from baseline for Donepezil 10 mg/day versus placebo. The x-axis represents SIB change from baseline, and the y-axis shows cumulative percentage of patients up to 100%. Data points for Donepezil are marked with solid circles, and placebo data with open squares. A vertical dashed line marks zero change on the x-axis.*

FDA Label Image

Graph9 (Graph9)

A line graph depicting the mean change from baseline in ADCS-ADL scores over 6 months of drug treatment. It compares Donepezil 10 mg/day and placebo, showing clinical improvement and decline along the y-axis with values ranging from -4 to 4, and months of drug treatment on the x-axis (0, 3, 6). Donepezil shows less decline compared to placebo.*

FDA Label Image

Structure (Structure)

Chemical structure of Donepezil hydrochloride, showing its molecular components including aromatic rings, methoxy groups, a ketone group, and a piperidine ring, with associated hydrochloride and water molecules indicated.*

* 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.