Donepezil Hydrochloride
Product Images NDC 55648-312

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Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Donepezil Hydrochloride (NDC 55648-312). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Wockhardt 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

Structure (Donephcltabs Figure 01)

Structure (Donephcltabs Figure 01)
Chemical structure of Donepezil Hydrochloride shown as a 2D molecular diagram, including a methoxy-substituted indanone linked to a piperidine ring and a benzyl group, along with the hydrochloride component.*
FDA Label Image

Figure 1 (Donephcltabs Figure 02)

Figure 1 (Donephcltabs Figure 02)
A line graph depicting the time-course of change from baseline in ADAS-cog scores over 24 weeks for Donepezil Hydrochloride 10 mg/day, 5 mg/day, and placebo groups. The y-axis shows ADAS-cog change from baseline with clinical improvement upward and decline downward. The x-axis shows weeks of drug treatment with a placebo period indicated at the end. Data points include error bars representing standard error.*
FDA Label Image

Figure 2 (Donephcltabs Figure 03)

Figure 2 (Donephcltabs Figure 03)
A cumulative percentage of patients chart depicting change from baseline on the x-axis and cumulative percentage of patients on the y-axis. It compares Donepezil Hydrochloride 10 mg/day, 5 mg/day, and placebo groups with curves indicating patient response changes. A table shows ADAS-cog change values for each treatment group at points -7, -4, and 0.*
FDA Label Image

Figrure 3 (Donephcltabs Figure 04)

Figrure 3 (Donephcltabs Figure 04)
A bar chart depicting the frequency distribution of CIBIC plus scores at Week 24. The chart shows the percentage of patients across categories from Markedly Improved to Markedly Worse, comparing Donepezil Hydrochloride 10 mg/day, 5 mg/day, and placebo groups as indicated by black, gray, and white bars respectively.*
FDA Label Image

Figure 4 (Donephcltabs Figure 05)

Figure 4 (Donephcltabs Figure 05)
A line graph showing the time-course of change from baseline in ADAS-cog scores over 15 weeks of drug treatment for Donepezil Hydrochloride at 5 mg/day and 10 mg/day doses compared to placebo. The y-axis represents mean change in ADAS-cog score, with clinical improvement indicated above baseline and clinical decline below. The x-axis represents weeks of treatment. The graph shows better cognitive improvement over time with Donepezil Hydrochloride compared to placebo.*
FDA Label Image

Figure 5 (Donephcltabs Figure 06)

Figure 5 (Donephcltabs Figure 06)
A cumulative percentage chart showing changes from baseline ADAS-cog scores in patients treated with Donepezil Hydrochloride 5 mg/day, 10 mg/day, and placebo. The x-axis represents change from baseline, while the y-axis shows cumulative percentage of patients. A legend identifies treatment groups with different markers. A table details the percent change in ADAS-cog scores at thresholds of -7, -4, and 0 points for each group.*
FDA Label Image

Figure 6 (Donephcltabs Figure 07)

Figure 6 (Donephcltabs Figure 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 groups. The x-axis lists CIBIC-plus rating categories from Markedly Improved to Markedly Worse, and the y-axis shows the percentage of patients. The chart compares the patient response distribution across these three groups.*
FDA Label Image

Figure 7 (Donephcltabs Figure 08)

Figure 7 (Donephcltabs Figure 08)
A line graph depicting the time course of change from baseline in SIB score for patients over 6 months of drug treatment. It compares Donepezil Hydrochloride 10 mg/day to placebo, showing clinical improvement above baseline and clinical decline below baseline, with data points and error bars at 0, 3, and 6 months.*
FDA Label Image

Figure 8 (Donephcltabs Figure 09)

Figure 8 (Donephcltabs Figure 09)
A cumulative percentage graph comparing patients receiving Donepezil Hydrochloride 10 mg/day versus placebo, showing the cumulative percentage of patients completing 6 months of double-blind treatment based on changes from baseline in SIB scores. The x-axis represents SIB change from baseline, the y-axis shows cumulative percentage of patients, with Donepezil Hydrochloride represented by solid circles and placebo by open squares.*
FDA Label Image

Figure 9 (Donephcltabs Figure 10)

Figure 9 (Donephcltabs Figure 10)
A line graph showing the time course of change from baseline in ADCS-ADL-Severe scores over 6 months of drug treatment. The graph compares Donepezil Hydrochloride 10 mg/day versus placebo, with the vertical axis indicating mean change from baseline and the horizontal axis showing months of treatment.*
FDA Label Image

Figure 10 (Donephcltabs Figure 11)

Figure 10 (Donephcltabs Figure 11)
A cumulative percentage graph showing patients completing 6 months of double-blind treatment, comparing Donepezil Hydrochloride 10 mg/day with placebo. The x-axis represents ADCS-ADL change from baseline scores, and the y-axis shows the cumulative percentage of patients. Donepezil shows a higher cumulative percentage at positive changes compared to placebo.*
FDA Label Image

Container Label (Donephcltabs Figure 12)

Container Label (Donephcltabs Figure 12)
Label for Donepezil HCl Tablets 5 mg by Wockhardt Limited. The label indicates a package of 30 tablets, with instructions to dispense in tight containers and keep at controlled room temperature (20°-25°C). It includes a barcode, NDC 64679-311-01, and states the product is Rx only with directions to provide a patient information sheet.*
FDA Label Image

Container Label (Donephcltabs Figure 13)

Container Label (Donephcltabs Figure 13)
Donepezil HCl Tablets 10 mg label showing the product name, dosage strength, and quantity of 30 tablets. Manufactured by Wockhardt Limited in Mumbai, India, and distributed by Wockhardt LLC in the USA. The label includes dosage instructions advising to see accompanying prescribing information, storage conditions, and a barcode.*

* 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.