Donepezil Hydrochloride Tablet
Product Images NDC 68180-527

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Product Visual Gallery

This gallery contains 15 technical images submitted to the FDA as part of the official labeling for Donepezil Hydrochloride (NDC 68180-527). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Lupin Pharmaceuticals, 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.

FDA Label Image

Donepezil Hydrochloride (3bfe818b 5567 4e5d 8204 1db3190c7169 01)

Donepezil Hydrochloride (3bfe818b 5567 4e5d 8204 1db3190c7169 01)
Chemical structure of Donepezil Hydrochloride, showing its molecular composition and arrangement, including aromatic rings and functional groups as part of its chemical formula.*
FDA Label Image

Figure 1. Time-course Of The Change From Baseline In Adas-cog Score For Patients Completing 24 Weeks Of Treatment. (3bfe818b 5567 4e5d 8204 1db3190c7169 02)

Figure 1. Time-course Of The Change From Baseline In Adas-cog Score For Patients Completing 24 Weeks Of Treatment. (3bfe818b 5567 4e5d 8204 1db3190c7169 02)
A line graph depicting the change from baseline in ADAS-cog scores over 24 weeks of drug treatment, comparing Donepezil Hydrochloride 10 mg/day, Donepezil Hydrochloride 5 mg/day, and placebo groups. The vertical axis represents the mean change in score, with clinical improvement indicated upward and clinical decline downward. The horizontal axis shows weeks of treatment with a placebo phase after 24 weeks. Donepezil groups show improvement or stabilization, while placebo shows decline.*
FDA Label Image

Figure 2 (3bfe818b 5567 4e5d 8204 1db3190c7169 03)

Figure 2 (3bfe818b 5567 4e5d 8204 1db3190c7169 03)
A cumulative percentage graph depicting patient response to Donepezil Hydrochloride at 5 mg/day and 10 mg/day doses compared to placebo. The x-axis shows change from baseline in ADAS-cog scores, with negative values indicating improvement. The y-axis represents cumulative percentage of patients. A table within the graph summarizes percentages of patients achieving changes of -7, -4, and 0 in ADAS-cog scores across treatment groups.*
FDA Label Image

Figure 3 (3bfe818b 5567 4e5d 8204 1db3190c7169 04)

Figure 3 (3bfe818b 5567 4e5d 8204 1db3190c7169 04)
A bar graph illustrating patient response to Donepezil Hydrochloride at 10 mg/day and 5 mg/day compared to placebo, measured by CIBIC-plus rating categories ranging from Markedly Improved to Markedly Worse. The y-axis shows the percentage of patients, and the data indicates varying degrees of improvement, no change, or worsening across the three groups.*
FDA Label Image

Figure 4 (3bfe818b 5567 4e5d 8204 1db3190c7169 05)

Figure 4 (3bfe818b 5567 4e5d 8204 1db3190c7169 05)
A line graph showing changes from baseline in ADAS-cog scores over 15 weeks, comparing Donepezil Hydrochloride 10 mg/day, Donepezil Hydrochloride 5 mg/day, and placebo. The x-axis represents weeks of drug treatment, including a placebo period after 12 weeks. The y-axis shows the mean change from baseline with error bars, illustrating clinical improvement and decline.*
FDA Label Image

Figure 5 (3bfe818b 5567 4e5d 8204 1db3190c7169 06)

Figure 5 (3bfe818b 5567 4e5d 8204 1db3190c7169 06)
A line graph showing the cumulative percentage of patients versus change from baseline in ADAS-cog scores for Donepezil Hydrochloride 5 mg/day, 10 mg/day, and placebo groups. The graph depicts improvement patterns over time, illustrating a greater positive change in cognitive scores for the Donepezil groups compared to placebo.*
FDA Label Image

Figure 6 (3bfe818b 5567 4e5d 8204 1db3190c7169 07)

Figure 6 (3bfe818b 5567 4e5d 8204 1db3190c7169 07)
A bar chart showing the distribution of CIBIC-plus ratings categorized as Markedly Improved, Moderately Improved, Minimally Improved, No Change, Minimally Worse, Moderately Worse, and Markedly Worse. The chart compares percentages of patients across three groups: Donepezil Hydrochloride 10 mg/day, Donepezil Hydrochloride 5 mg/day, and Placebo, with Placebo generally showing higher percentages in No Change and worse categories.*
FDA Label Image

Figure 7 (3bfe818b 5567 4e5d 8204 1db3190c7169 08)

Figure 7 (3bfe818b 5567 4e5d 8204 1db3190c7169 08)
A line graph depicting change in SIB (Severe Impairment Battery) scores from baseline over 6 months of drug treatment. It compares the effects of Donepezil Hydrochloride 10 mg/day and placebo, showing clinical improvement and decline trends with error bars representing standard error.*
FDA Label Image

Figure 8 (3bfe818b 5567 4e5d 8204 1db3190c7169 09)

Figure 8 (3bfe818b 5567 4e5d 8204 1db3190c7169 09)
A cumulative percentage graph comparing Donepezil Hydrochloride 10 mg/day and placebo over time, showing patient response in SIB (Severe Impairment Battery) change from baseline. The x-axis represents the SIB change from baseline, and the y-axis shows the cumulative percentage of patients. Two lines display the comparative effects of treatment and placebo.*
FDA Label Image

Figure 9 (3bfe818b 5567 4e5d 8204 1db3190c7169 10)

Figure 9 (3bfe818b 5567 4e5d 8204 1db3190c7169 10)
A line graph comparing the mean change from baseline in ADCS-ADL scores over 6 months between Donepezil Hydrochloride 10 mg/day and placebo groups. The y-axis shows clinical improvement and decline, with Donepezil Hydrochloride demonstrating less decline than placebo.*
FDA Label Image

Figure 10 (3bfe818b 5567 4e5d 8204 1db3190c7169 11)

Figure 10 (3bfe818b 5567 4e5d 8204 1db3190c7169 11)
A cumulative percentage plot showing ADCS-ADL change from baseline in patients treated with Donepezil Hydrochloride 10 mg/day versus placebo. The x-axis represents ADCS-ADL change from baseline, ranging from 20 to -20, and the y-axis shows the cumulative percentage of patients from 0 to 100. Donepezil is represented by filled circles, placebo by open squares, illustrating a distribution shift between the two groups.*
FDA Label Image

Figure 11 (3bfe818b 5567 4e5d 8204 1db3190c7169 12)

Figure 11 (3bfe818b 5567 4e5d 8204 1db3190c7169 12)
A line graph showing the change from baseline in Severe Impairment Battery (SIB) scores over 24 weeks of treatment with Donepezil Hydrochloride at 23 mg/day and 10 mg/day doses. The graph displays mean least squares (LS) changes with standard error bars, indicating clinical improvement above baseline and clinical decline below baseline across the treatment period.*
FDA Label Image

Figure 12 (3bfe818b 5567 4e5d 8204 1db3190c7169 13)

Figure 12 (3bfe818b 5567 4e5d 8204 1db3190c7169 13)
A cumulative percentage of patients graph comparing the effect of Donepezil Hydrochloride 23 mg/day and 10 mg/day on SIB change from baseline. The x-axis represents SIB change from baseline, and the y-axis shows the cumulative percentage of patients. Two plots show patient response distributions for the two dosages.*
FDA Label Image

Figure 13 (3bfe818b 5567 4e5d 8204 1db3190c7169 14)

Figure 13 (3bfe818b 5567 4e5d 8204 1db3190c7169 14)
A bar chart comparing the percentage of patients rated on the CIBIC-plus scale for Donepezil Hydrochloride 23 mg/day and 10 mg/day. The categories range from Markedly Improved to Markedly Worse, showing patient distribution across different levels of improvement or worsening.*
FDA Label Image

Donepezil Hydrochloride Tabletsrx Only23 mgndc 68180-527-06 30 Tablets (3bfe818b 5567 4e5d 8204 1db3190c7169 15)

Donepezil Hydrochloride Tabletsrx Only23 mgndc 68180-527-06							30 Tablets (3bfe818b 5567 4e5d 8204 1db3190c7169 15)
Donepezil Hydrochloride 23 mg oral tablets packaging label by Lupin Pharmaceuticals, Inc. The label indicates 30 film-coated tablets per package with NDC 68180-527-06. It includes storage instructions, dispensing information, and manufacturer details from Lupin Pharmaceuticals and Lupin Limited.*

* 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.