Donepezil Hydrochloride Tablet, Film Coated
Product Images NDC 16571-779

16 FDA label images from Rising Pharma Holdings, Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 16 technical images submitted to the FDA as part of the official labeling for Donepezil Hydrochloride (NDC 16571-779). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Rising Pharma Holdings, Inc., these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

Product Images & Figures Index

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)

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 depicting mean change from baseline on the ADAS-cog scale over 30 weeks of drug treatment. It compares three groups: Donepezil Hydrochloride 10 mg/day, Donepezil Hydrochloride 5 mg/day, and placebo. The y-axis shows clinical improvement versus decline, and the x-axis shows weeks of treatment, with the placebo period indicated.*
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)

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 cumulative percentage chart comparing Donepezil Hydrochloride 10 mg/day and placebo groups based on ADCS-ADL change from baseline. The x-axis shows ADCS-ADL change ranging from +20 to -20, while the y-axis shows cumulative percentage of patients from 0% to 100%. The graph depicts two curves representing patient response distribution for the active drug and placebo.*
FDA Label Image

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

Figure 11. Time-course Of The Change From Baseline In Sib Score For Patients Completing 24 Weeks Of Treatment. (Donepezil Fig11)
A line chart showing the change from baseline in SIB score over 24 weeks of treatment with Donepezil Hydrochloride at 10 mg/day and 23 mg/day. The graph indicates clinical improvement or decline relative to baseline, with the 23 mg/day dose showing greater improvement than the 10 mg/day dose across the treatment period.*
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)

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 graph showing the change from baseline in SIB scores for Donepezil Hydrochloride at 23 mg/day and 10 mg/day dosages. The x-axis represents SIB changes from baseline, while the y-axis shows cumulative percentage of patients. The higher dose group is represented by diamonds, the lower dose by circles.*
FDA Label Image

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

Figure 13. Frequency Distribution Of Cibic-plus Scores At Week 24. (Donepezil Fig13)
Bar chart comparing the percentage of patients by CIBIC-plus rating categories for Donepezil Hydrochloride at 23 mg/day and 10 mg/day doses. Categories include Markedly Improved, Moderately Improved, Minimally Improved, No Change, Minimally Worse, Moderately Worse, and Markedly Worse.*
FDA Label Image

Package Label-principal Display Panel (5 mg (100 Tablet Bottle))

Package Label-principal Display Panel (5 mg (100 Tablet Bottle))
Donepezil Hydrochloride Tablets USP 5 mg film-coated tablet carton label by Rising Pharma Holdings, Inc. The label shows 30 tablets per package with a green 5 mg strength indicator. Storage instructions and dispensing information are included. Distributed by Rising Pharma Holdings, Inc., East Brunswick, NJ, made in India. Barcode and manufacturing codes are visible.*
FDA Label Image

Package Label-principal Display Panel (10 mg (30 Tablet Bottle))

Package Label-principal Display Panel (10 mg (30 Tablet Bottle))
Donepezil Hydrochloride Tablets USP 10 mg film-coated tablets packaging label showing 30 tablets per bottle. Manufactured by Rising Pharma Holdings, Inc., with storage instructions and dosage caution noted. The label includes a barcode and states the product is made in India and distributed in East Brunswick, NJ.*
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)

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 graph depicting changes in ADAS-cog scores from baseline for patients treated with placebo, Donepezil Hydrochloride 5 mg, and Donepezil Hydrochloride 10 mg. The x-axis shows change from baseline, and the y-axis shows cumulative percentage of patients. The graph includes a table summarizing changes in ADAS-cog at -7, -4, and 0 points for each treatment group.*
FDA Label Image

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

Figure 3. Frequency Distribution Of Cibic-plus Scores At Week 24. (Donepezil Fig3)
A bar chart comparing the percentages of patients in various improvement or worsening categories based on CIBIC-plus rating for three groups: Donepezil Hydrochloride 10 mg/day, Donepezil Hydrochloride 5 mg/day, and placebo. 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)

Figure 4. Time-course Of The Change From Baseline In Adas-cog Score For Patients Completing The 15-week Study. (Donepezil Fig4)
A line chart depicting ADAS-cog change from baseline (mean ± SE) over 15 weeks of drug treatment, comparing Donepezil Hydrochloride 10 mg/day, Donepezil Hydrochloride 5 mg/day, and placebo. The vertical axis shows clinical improvement and decline relative to baseline, and the horizontal axis represents weeks of treatment.*
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)

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 of patients line graph comparing change from baseline in ADAS-cog scores for Donepezil Hydrochloride 10 mg/day, 5 mg/day, and placebo groups. The x-axis shows change from baseline, the y-axis shows cumulative percentage of patients, with markers indicating 7 points, 4 points, and no change thresholds.*
FDA Label Image

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

Figure 6. Frequency Distribution Of Cibic-plus Scores At Week 12. (Donepezil Fig6)
A bar chart comparing the percentage of patients rated on the CIBIC-plus scale across three groups: Donepezil Hydrochloride 10 mg/day, Donepezil Hydrochloride 5 mg/day, and placebo. The categories include markedly improved, moderately improved, minimally improved, no change, minimally worse, moderately worse, and markedly worse.*
FDA Label Image

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

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 0, 3, and 6 months of drug treatment comparing Donepezil Hydrochloride 10 mg/day versus placebo. The vertical axis represents SIB change with clinical improvement upward and clinical decline downward. Donepezil shows an increase indicating clinical improvement, while placebo shows a decline.*
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)

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 curve chart comparing Donepezil Hydrochloride 10 mg/day and placebo groups. The x-axis represents SIB change from baseline, while the y-axis shows the cumulative percentage of patients. The graph indicates patient response distributions to Donepezil Hydrochloride versus placebo over the measured range.*
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)

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 showing the mean change from baseline in ADCS-ADL scores over 6 months of drug treatment. Two lines compare Donepezil Hydrochloride 10 mg/day and placebo groups, with Donepezil showing less decline than placebo. The y-axis ranges from clinical improvement to clinical decline, and the x-axis represents months of treatment (0, 3, 6).*
FDA Label Image

Chemical Structure (Donepezil Str)

Chemical Structure (Donepezil Str)
Chemical structure of Donepezil Hydrochloride, showing its molecular framework including methoxy groups, piperidine ring, and phenyl linkage with hydrochloride salt.*

* 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.