Donepezil Hydrochloride Tablet, Film Coated
Product Images NDC 24979-004

17 FDA label images from Upsher-smith Laboratories, Llc · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 17 technical images submitted to the FDA as part of the official labeling for Donepezil Hydrochloride (NDC 24979-004). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Upsher-smith Laboratories, 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.

FDA Label Image

01 (30406488 Figure 01)

01 (30406488 Figure 01)
Chemical structure of Donepezil Hydrochloride showing the molecular arrangement with methoxy groups on an aromatic ring, a piperidine ring, and a phenyl group attached to a hydrochloride molecule.*
FDA Label Image

Figure2 (30406488 Figure 02)

Figure2 (30406488 Figure 02)
Line graph showing ADAS-cog change from baseline over 24 weeks of drug treatment and a 6-week placebo period. The graph compares Donepezil Hydrochloride Tablets at 10 mg/day and 5 mg/day versus placebo, with clinical improvement indicated by negative values and clinical decline by positive values on the y-axis. Error bars represent standard error (±SE).*
FDA Label Image

Figure-03 (30406488 Figure 03)

Figure-03 (30406488 Figure 03)
A cumulative percentage graph showing patient response to Donepezil Hydrochloride Tablets at 5 mg/day and 10 mg/day versus placebo. The x-axis represents change from baseline in ADAS-cog scores, and the y-axis shows cumulative percentage of patients. The chart includes markers for 7 points, 4 points, and no change, and a table summarizing response percentages in each treatment group for these score changes.*
FDA Label Image

Figure-04 (30406488 Figure 04)

Figure-04 (30406488 Figure 04)
A bar chart depicting the distribution of patient CIBIC-plus ratings comparing Donepezil Hydrochloride Tablets 10 mg/day, 5 mg/day, and placebo. The x-axis shows categories from 'Markedly Improved' to 'Markedly Worse,' while the y-axis indicates the percentage of patients. The chart illustrates variations in patient ratings among the three groups.*
FDA Label Image

Figure-05 (30406488 Figure 05)

Figure-05 (30406488 Figure 05)
A line graph showing ADAS-cog change from baseline (mean ± SE) over 12 weeks of drug treatment and 3 weeks of placebo. It compares Donepezil Hydrochloride Tablets at 10 mg/day, 5 mg/day, and placebo, illustrating clinical improvement and decline relative to baseline across treatment weeks.*
FDA Label Image

Figure-06 (30406488 Figure 06)

Figure-06 (30406488 Figure 06)
This chart shows the cumulative percentage of patients plotted against change from baseline in ADAS-cog score. It compares three groups: Placebo, Donepezil Hydrochloride tablets 5 mg/day, and Donepezil Hydrochloride tablets 10 mg/day, with data points marked for changes of -7, -4, and 0. A table summarizes the percentage of patients reaching these change thresholds by treatment group.*
FDA Label Image

Figure-07 (30406488 Figure 07)

Figure-07 (30406488 Figure 07)
Bar chart depicting the percentage of patients experiencing various degrees of improvement or worsening while on Donepezil Hydrochloride Tablets at doses of 10 mg/day and 5 mg/day, compared to placebo. Categories on the x-axis range from Markedly Improved to Markedly Worse, with the y-axis showing percentage of patients.*
FDA Label Image

08 (30406488 Figure 08)

08 (30406488 Figure 08)
Line chart showing SIB change from baseline mean (±SE) over 6 months of drug treatment comparing Donepezil Hydrochloride Tablets 10 mg/day and placebo. The y-axis represents SIB change from baseline with clinical improvement above and clinical decline below. Donepezil shows an increase in SIB score, indicating clinical improvement, while placebo shows a decrease, indicating clinical decline.*
FDA Label Image

09 (30406488 Figure 09)

09 (30406488 Figure 09)
A cumulative percentage graph comparing patients on Donepezil Hydrochloride Tablets 10 mg/day versus placebo, plotted against SIB change from baseline. The Y-axis shows cumulative percentage of patients, while the X-axis shows negative SIB change values. Donepezil shows a higher cumulative percentage improvement compared to placebo.*
FDA Label Image

10 (30406488 Figure 10)

10 (30406488 Figure 10)
A line graph showing ADCS-ADL change from baseline over 6 months of drug treatment for Donepezil Hydrochloride Tablets 10 mg/day compared to placebo. The y-axis represents mean change with standard error, ranging from clinical improvement to clinical decline, while the x-axis shows months of treatment. Donepezil shows less decline than placebo over time.*
FDA Label Image

11 (30406488 Figure 11)

11 (30406488 Figure 11)
A line graph comparing the cumulative percentage of patients versus ADCS-ADL change from baseline for Donepezil Hydrochloride 10 mg/day tablets and placebo. The x-axis represents the ADCS-ADL change from baseline, ranging from +20 to -20, and the y-axis shows the cumulative percentage of patients from 0% to 100%. Two lines plot patient responses: one with filled circles for Donepezil Hydrochloride tablets and one with open squares for placebo.*
FDA Label Image

12 (30406488 Figure 12)

12 (30406488 Figure 12)
A line graph showing the SIB change from baseline over 24 weeks of treatment with Donepezil Hydrochloride Tablets at 23 mg/day and 10 mg/day. The graph plots LS mean (±SE) on the y-axis against weeks of drug treatment on the x-axis, indicating clinical improvement above baseline and clinical decline below baseline.*
FDA Label Image

13 (30406488 Figure 13)

13 (30406488 Figure 13)
A cumulative percentage of patients graph comparing SIB (Severe Impairment Battery) change from baseline for Donepezil Hydrochloride Tablets at 23 mg/day and 10 mg/day doses. The x-axis shows SIB change from baseline ranging from 50 to -60, and the y-axis shows cumulative percentage of patients from 0 to 100%, with two plotted lines representing each dosage group's distribution of patient response.*
FDA Label Image

14 (30406488 Figure 14)

14 (30406488 Figure 14)
A bar graph comparing percentages of patients' CIBIC-plus Ratings for Donepezil Hydrochloride Tablets at 23 mg/day and 10 mg/day dosages. The x-axis shows categories from Markedly Improved to Markedly Worse, and the y-axis shows the percentage of patients. The graph displays patient response distributions for two dosage groups with colored bars: black for 23 mg/day and white for 10 mg/day.*
FDA Label Image

15 (30406488 Figure 15)

FDA Label Image

16 (30406488 Figure 16)

16 (30406488 Figure 16)
Donepezil Hydrochloride 23 mg film-coated tablets label for oral use. The label shows 30 tablets in the package. It includes dosage strength, manufacturer information (TWi Pharmaceuticals USA, Inc. and TWi Pharmaceuticals, Inc., Taiwan), storage directions, and a barcode. The product is prescription only with NDC 24979-004-06.*
FDA Label Image

17 (30406488 Figure 17)

17 (30406488 Figure 17)
Label for Donepezil Hydrochloride 23 mg film-coated tablets, USP, oral use. The label indicates 90 tablets per package, manufactured by TWi Pharmaceuticals, Inc. in Taiwan for TWi Pharmaceuticals USA, Inc. Displays NDC 24979-004-07, storage instructions, and dispensing information.*

* 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.