Donepezil Hydrochloride Tablet, Film Coated
Product Images NDC 71335-2346

Product Visual Gallery

This gallery contains 15 technical images submitted to the FDA as part of the official labeling for Donepezil Hydrochloride (NDC 71335-2346). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Bryant Ranch Prepack, 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

Figure 1. Time-course Of The Change From Baseline In Adas-cog Score For Patients Completing 24 Weeks Of Treatment. (Donepezil Fig1)

A line graph showing clinical progression measured by ADAS-cog change from baseline over 30 weeks of drug treatment. The graph compares Donepezil Hydrochloride at 10 mg/day and 5 mg/day doses against placebo, illustrating mean changes with standard error bars. The y-axis indicates clinical improvement versus decline, and the x-axis represents weeks of treatment.*

FDA Label Image

Figure 10. Cumulative Percentage Of Patients Completing 6 Months Of Double-blind Treatment With Particular Changes From Baseline In Adcs-adl-severe Scores. (Donepezil Fig10)

A line graph showing the cumulative percentage of patients plotted against ADCS-ADL change from baseline. Two curves compare Donepezil Hydrochloride 10 mg/day and a placebo, indicating patient response distributions with changes from baseline on the horizontal axis and cumulative patient percentages on the vertical axis.*

FDA Label Image

Figure 11. Time-course Of The Change From Baseline In Sib Score For Patients Completing 24 Weeks Of Treatment. (Donepezil Fig11)

A line chart depicting SIB (Severe Impairment Battery) change from baseline over 24 weeks of drug treatment comparing Donepezil Hydrochloride 23 mg/day and 10 mg/day. The y-axis shows SIB change from baseline, indicating clinical improvement above baseline and clinical decline below. The 23 mg/day dose shows greater improvement over time compared to the 10 mg/day dose.*

FDA Label Image

Figure 12. Cumulative Percentage Of Patients Completing 24 Weeks Of Double-blind Treatment With Specified Changes From Baseline Sib Scores. (Donepezil Fig12)

A cumulative percentage of patients chart comparing SIB (Severe Impairment Battery) change from baseline for Donepezil Hydrochloride at doses of 23 mg/day and 10 mg/day. The x-axis shows SIB change ranging from 50 to -60, while the y-axis shows the cumulative percentage of patients from 0 to 100%, with data points for each dose represented by diamond and circle markers.*

FDA Label Image

Figure 13. Frequency Distribution Of Cibic-plus Scores At Week 24. (Donepezil Fig13)

A bar chart comparing patient percentages based on CIBIC-plus Ratings for Donepezil Hydrochloride 23 mg/day and 10 mg/day. The ratings range from Markedly Improved to Markedly Worse, showing most patients reported No Change, with varying distributions for other rating categories between the two dose groups.*

FDA Label Image

Figure 2. Cumulative Percentage Of Patients Completing 24 Weeks Of Double-blind Treatment With Specified Changes From Baseline Adas-cog Scores. The Percentages Of Randomized Patients Who Completed The Study Were: Placebo 80%, 5 mg/day 85%, And 10 mg/day 68%. (Donepezil Fig2)

A cumulative percentage of patients graph illustrating change from baseline in ADAS-cog scores for placebo, Donepezil Hydrochloride 5 mg, and Donepezil Hydrochloride 10 mg groups. The chart shows treatment impact with curves and a table summarizing percentage of patients at specific change points in cognitive scores.*

FDA Label Image

Figure 3. Frequency Distribution Of Cibic-plus Scores At Week 24. (Donepezil Fig3)

A bar graph showing the distribution of patient percentages across CIBIC-plus rating categories comparing Donepezil Hydrochloride 10 mg/day, 5 mg/day, and placebo groups. Categories include Markedly Improved, Moderately Improved, Minimally Improved, No Change, Minimally Worse, Moderately Worse, and Markedly Worse.*

FDA Label Image

Figure 4. Time-course Of The Change From Baseline In Adas-cog Score For Patients Completing The 15-week Study. (Donepezil Fig4)

A line graph showing ADAS-cog mean change from baseline (±SE) over weeks of drug treatment for Donepezil Hydrochloride 10 mg/day, 5 mg/day, and placebo groups. The y-axis measures ADAS-cog change with clinical improvement above baseline and clinical decline below. The x-axis shows weeks from 0 to 15, including a placebo period after 12 weeks. Both Donepezil doses show clinical improvement while placebo trends toward clinical decline.*

FDA Label Image

Figure 5. Cumulative Percentage Of Patients With Specified Changes From Baseline Adas-cog Scores. The Percentages Of Randomized Patients Within Each Treatment Group Who Completed The Study Were: Placebo 93%, 5 mg/day 90%, And 10 mg/day 82%. (Donepezil Fig5)

A cumulative percentage graph 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 change from baseline, while the y-axis shows cumulative percentage of patients, with treatment groups indicated by different markers. The graph illustrates efficacy comparisons between doses and placebo over a range of score changes.*

FDA Label Image

Figure 6. Frequency Distribution Of Cibic-plus Scores At Week 12. (Donepezil Fig6)

A bar graph comparing the percentage of patients across CIBIC-plus rating categories among three groups: Donepezil Hydrochloride 10 mg/day, Donepezil Hydrochloride 5 mg/day, and placebo. The categories range from markedly improved to markedly worse, with no change and minimal improvement or worsening also shown.*

FDA Label Image

Figure 7. Time Course Of The Change From Baseline In Sib Score For Patients Completing 6 Months Of Treatment. (Donepezil Fig7)

A line graph showing SIB change from baseline (Mean ±SE) over 6 months of drug treatment comparing Donepezil Hydrochloride 10 mg/day with placebo. The vertical axis represents SIB change from baseline, with clinical improvement above baseline and clinical decline below. The horizontal axis shows months of treatment (0, 3, 6). Donepezil shows an increase in SIB score by month 3 with slight decrease by month 6, while placebo shows a decline over time.*

FDA Label Image

Figure 8. Cumulative Percentage Of Patients Completing 6 Months Of Double-blind Treatment With Particular Changes From Baseline In Sib Scores. (Donepezil Fig8)

A cumulative percentage of patients chart comparing Donepezil Hydrochloride 10 mg/day and placebo groups. The x-axis shows SIB change from baseline, ranging approximately from 30 to -75. The y-axis shows cumulative percentage of patients from 0% to 100%. Data points for Donepezil Hydrochloride are marked with filled circles, and placebo with open squares, illustrating a greater cumulative patient response with Donepezil compared to placebo.*

FDA Label Image

Figure 9. Time Course Of The Change From Baseline In Adcs-adl-severe Score For Patients Completing 6 Months Of Treatment. (Donepezil Fig9)

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 x-axis shows months of treatment (0, 3, 6), and the y-axis shows mean change from baseline with standard error bars. The graph indicates less clinical decline with Donepezil Hydrochloride compared to placebo.*

FDA Label Image

Chemical Structure (Donepezil Str)

Chemical structure of Donepezil Hydrochloride, showing its molecular arrangement including methoxy groups and a piperidine ring connected to a benzyl group with an associated hydrochloride (HCl) component.*

FDA Label Image

Label (Lbl713352346)

Label for Donepezil HCl Tablets, USP 10 mg film-coated tablets, oral dosage form. The package contains 30 tablets and is repackaged by Bryant Ranch Prepack, Inc., Burbank, CA, with manufacturing by Aurobindo Pharma Limited. Storage instructions specify 20 to 25°C with permitted excursions. The NDC 71335-2346-1 and barcodes are 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.