Donepezil Hydrochloride
Product Images NDC 42254-305

12 FDA label images from Rebel Distributors Corp · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Donepezil Hydrochloride (NDC 42254-305). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Rebel Distributors Corp, 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

Structure (09b48fda 460a 496b 8644 Db205465d06c 01)

Structure (09b48fda 460a 496b 8644 Db205465d06c 01)
Chemical structure diagram of donepezil hydrochloride, showing the molecular framework including methoxy groups on the aromatic ring, a piperidine moiety, and a phenyl group attached to the nitrogen, with the hydrochloride moiety indicated.*
FDA Label Image

Figure 1 (09b48fda 460a 496b 8644 Db205465d06c 02)

Figure 1 (09b48fda 460a 496b 8644 Db205465d06c 02)
Line graph showing the time-course change from baseline in ADAS-cog scores for patients treated with Donepezil Hydrochloride 5 mg/day, 10 mg/day, and placebo over 24 weeks. The y-axis represents the ADAS-cog score change, with decreases indicating clinical improvement, and the x-axis shows weeks of drug treatment. Lines indicate test groups with error bars for standard error.*
FDA Label Image

Figure 2 (09b48fda 460a 496b 8644 Db205465d06c 03)

Figure 2 (09b48fda 460a 496b 8644 Db205465d06c 03)
A cumulative percentage graph showing change from baseline in ADAS-cog scores for Donepezil Hydrochloride at 5 mg/day and 10 mg/day doses versus placebo. The X-axis represents change from baseline ranging from -15 to 15, and the Y-axis shows cumulative percentage of patients from 0 to 100%. The graph includes vertical lines marking 7 points, 4 points, and no change, and a table summarizing percent change in ADAS-cog by treatment group.*
FDA Label Image

Figure 3 (09b48fda 460a 496b 8644 Db205465d06c 04)

Figure 3 (09b48fda 460a 496b 8644 Db205465d06c 04)
A bar chart titled 'CIBIC-plus Rating Frequency Distribution of CIBIC plus Scores at Week 24' compares the percentage of patients across seven outcome categories: Markedly Improved, Moderately Improved, Minimally Improved, No Change, Minimally Worse, Moderately Worse, and Markedly Worse. It displays data for Donepezil Hydrochloride 10 mg/day, Donepezil Hydrochloride 5 mg/day, and placebo groups, distinguished by black, gray, and white bars respectively.*
FDA Label Image

Figure 4 (09b48fda 460a 496b 8644 Db205465d06c 05)

Figure 4 (09b48fda 460a 496b 8644 Db205465d06c 05)
Line graph depicting the time-course change from baseline in ADAS-cog scores for patients treated with Donepezil Hydrochloride 10 mg/day, 5 mg/day, and placebo over a 15-week study. The vertical axis shows mean change in score, indicating clinical improvement or decline, and the horizontal axis lists weeks of drug treatment. The Donepezil groups show varying degrees of cognitive improvement compared to placebo.*
FDA Label Image

Figure 5 (09b48fda 460a 496b 8644 Db205465d06c 06)

Figure 5 (09b48fda 460a 496b 8644 Db205465d06c 06)
A cumulative percentage chart showing patients' change from baseline ADAS-cog scores for Donepezil Hydrochloride 5 mg/day, 10 mg/day, and placebo groups. The chart includes lines for each group and marks for 7 points, 4 points, and no change, with an inset table summarizing percentage changes at -7, -4, and 0 points for each treatment group.*
FDA Label Image

Figure 6 (09b48fda 460a 496b 8644 Db205465d06c 07)

Figure 6 (09b48fda 460a 496b 8644 Db205465d06c 07)
A bar chart showing the frequency distribution of CIBIC plus scores at Week 12 for Donepezil Hydrochloride 10 mg/day, 5 mg/day, and placebo. The x-axis represents CIBIC-plus ratings ranging from Markedly Improved to Markedly Worse, and the y-axis shows the percentage of patients. Bars compare patient response percentages across the three groups for each rating category.*
FDA Label Image

Figure 7 (09b48fda 460a 496b 8644 Db205465d06c 08)

Figure 7 (09b48fda 460a 496b 8644 Db205465d06c 08)
A line graph comparing the mean change from baseline in SIB (Severe Impairment Battery) score over 6 months of drug treatment between Donepezil Hydrochloride 10 mg/day and placebo groups. The y-axis shows SIB change from baseline, with clinical improvement and decline indicated. The x-axis represents months of drug treatment (0, 3, 6). Donepezil group shows clinical improvement while placebo shows decline.*
FDA Label Image

Figure 8 (09b48fda 460a 496b 8644 Db205465d06c 09)

Figure 8 (09b48fda 460a 496b 8644 Db205465d06c 09)
A line chart showing the cumulative percentage of patients completing 6 months of double-blind treatment with Donepezil Hydrochloride 10 mg/day versus placebo. The X-axis represents SIB change from baseline, and the Y-axis represents the cumulative percentage of patients, with Donepezil Hydrochloride represented by filled circles and placebo by open squares.*
FDA Label Image

Figure 9 (09b48fda 460a 496b 8644 Db205465d06c 10)

Figure 9 (09b48fda 460a 496b 8644 Db205465d06c 10)
A line graph showing the time course of change from baseline in ADCS-ADL-Severe scores over 6 months of treatment. It compares Donepezil Hydrochloride 10 mg/day (represented by solid circles) and placebo (open squares). The y-axis shows the mean change from baseline (±SE), with clinical improvement indicated above baseline and clinical decline below. Donepezil shows less decline compared to placebo over time.*
FDA Label Image

Figure 10 (09b48fda 460a 496b 8644 Db205465d06c 11)

Figure 10 (09b48fda 460a 496b 8644 Db205465d06c 11)
A cumulative percentage chart showing patients completing 6 months of double-blind treatment comparing Donepezil Hydrochloride 10 mg/day and placebo groups. The x-axis represents ADCS-ADL change from baseline, and the y-axis shows cumulative percentage of patients, illustrating shifts in ADCS-ADL-severe scores over time.*
FDA Label Image

Donepezil HCl 10mg (09b48fda 460a 496b 8644 Db205465d06c 12)

Donepezil HCl 10mg (09b48fda 460a 496b 8644 Db205465d06c 12)
Donepezil HCl 10 mg tablets label from Rebel Distributors Corp with NDC 42254-305-90. The label indicates 90 tablets per package, each containing 10 mg Donepezil Hydrochloride. The tablets are described as yellow, round, biconvex, film-coated, with specific debossed markings. Manufacturer is Wockhardt Limited, Mumbai, India. Storage instructions and distributor information from Physician Partner, Thousand Oaks, CA, are also included.*

* 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.