Donepezil Hydrochloride Tablet, Film Coated
Product Images NDC 43547-276

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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 43547-276). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Solco Healthcare Us, 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

Structural Formula (41d7651e B91a 4118 8719 Bf2f663d82a2 01)

Structural Formula (41d7651e B91a 4118 8719 Bf2f663d82a2 01)
Chemical structure of donepezil hydrochloride, showing its molecular arrangement with a benzylpiperidine moiety and an indanone group linked to the hydrochloride ion.*
FDA Label Image

Figure 1 (41d7651e B91a 4118 8719 Bf2f663d82a2 02)

Figure 1 (41d7651e B91a 4118 8719 Bf2f663d82a2 02)
Line graph depicting ADAS-cog change from baseline (mean ± SE) over 30 weeks comparing donepezil hydrochloride 10 mg/day, 5 mg/day, and placebo. The x-axis shows weeks of drug treatment with a placebo phase after week 24. The y-axis represents cognitive change, with clinical improvement above baseline and clinical decline below baseline. Both donepezil doses show sustained clinical improvement, while placebo shows increasing clinical decline.*
FDA Label Image

Figure 2 (41d7651e B91a 4118 8719 Bf2f663d82a2 03)

Figure 2 (41d7651e B91a 4118 8719 Bf2f663d82a2 03)
A cumulative percentage graph showing patient response over time with treatment groups for donepezil hydrochloride 10 mg/day, 5 mg/day, and placebo. The X-axis represents change from baseline and the Y-axis shows cumulative percentage of patients. A table within the graph shows percent changes in ADAS-cog scores at weeks -7, -4, and 0 for each treatment group.*
FDA Label Image

Figure 3 (41d7651e B91a 4118 8719 Bf2f663d82a2 04)

Figure 3 (41d7651e B91a 4118 8719 Bf2f663d82a2 04)
A vertical bar chart comparing the percentage of patients across CIBIC-plus Rating categories (Markedly Improved, Moderately Improved, Minimally Improved, No Change, Minimally Worse, Moderately Worse, Markedly Worse) for Donepezil hydrochloride 10 mg/day, 5 mg/day, and placebo groups. The chart shows relative distribution of patient responses under each treatment condition.*
FDA Label Image

Figure 4 (41d7651e B91a 4118 8719 Bf2f663d82a2 05)

Figure 4 (41d7651e B91a 4118 8719 Bf2f663d82a2 05)
A line graph showing the ADAS-cog mean change from baseline over 15 weeks of drug treatment comparing donepezil hydrochloride 10 mg/day, 5 mg/day, and placebo. The y-axis indicates clinical improvement and decline, and the x-axis shows weeks of treatment with a placebo period at the end. Error bars represent standard error of the mean.*
FDA Label Image

Figure 5 (41d7651e B91a 4118 8719 Bf2f663d82a2 06)

Figure 5 (41d7651e B91a 4118 8719 Bf2f663d82a2 06)
A line graph showing the cumulative percentage of patients plotted against change from baseline in ADAS-cog scores for three groups: donepezil hydrochloride 10 mg/day, donepezil hydrochloride 5 mg/day, and placebo. The graph illustrates score changes categorized as no change, 4 points improvement, and 7 points improvement, with a small table summarizing the percentage of patients in each treatment group achieving those changes.*
FDA Label Image

Figure 6 (41d7651e B91a 4118 8719 Bf2f663d82a2 07)

Figure 6 (41d7651e B91a 4118 8719 Bf2f663d82a2 07)
A bar graph depicting the percentage of patients categorized by CIBIC-plus Rating groups: Markedly Improved, Moderately Improved, Minimally Improved, No Change, Minimally Worse, Moderately Worse, and Markedly Worse. Data are displayed for three groups: Aricept 10 mg/day, Aricept 5 mg/day, and Placebo, showing comparative patient response rates across these categories.*
FDA Label Image

Figure 7 (41d7651e B91a 4118 8719 Bf2f663d82a2 08)

Figure 7 (41d7651e B91a 4118 8719 Bf2f663d82a2 08)
A line graph showing the change from baseline in SIB scores over 6 months of drug treatment. Two groups are compared: donepezil hydrochloride 10 mg/day and placebo. The graph indicates clinical improvement with donepezil and clinical decline with placebo over time, including error bars for standard error.*
FDA Label Image

Figure 8 (41d7651e B91a 4118 8719 Bf2f663d82a2 09)

Figure 8 (41d7651e B91a 4118 8719 Bf2f663d82a2 09)
A cumulative percentage of patients graph comparing donepezil hydrochloride 10 mg/day to placebo. The x-axis represents SIB change from baseline, and the y-axis represents the cumulative percentage of patients. Data points show donepezil with filled circles and placebo with open squares, illustrating differences in patient response distributions.*
FDA Label Image

Figure 9 (41d7651e B91a 4118 8719 Bf2f663d82a2 10)

Figure 9 (41d7651e B91a 4118 8719 Bf2f663d82a2 10)
A line graph displaying the mean change from baseline in ADCS-ADL scores over 6 months of drug treatment. The graph compares donepezil hydrochloride 10 mg/day against placebo, showing clinical improvement and decline on the vertical axis and months of treatment on the horizontal axis.*
FDA Label Image

Figure 10 (41d7651e B91a 4118 8719 Bf2f663d82a2 11)

Figure 10 (41d7651e B91a 4118 8719 Bf2f663d82a2 11)
A line graph depicting the cumulative percentage of patients against the ADCS-ADL change from baseline. Two curves compare donepezil hydrochloride 10 mg/day and placebo, illustrating patient response distribution over a range of ADCS-ADL score changes.*
FDA Label Image

Principal Display Panel – 5 mg Bottle Label (41d7651e B91a 4118 8719 Bf2f663d82a2 12)

Principal Display Panel – 5 mg Bottle Label (41d7651e B91a 4118 8719 Bf2f663d82a2 12)
Donepezil HCl Tablets, USP 5 mg film-coated tablets in a 30-tablet blister pack. The label includes storage instructions, manufacturer Zhejiang Huahai Pharmaceutical Co., Ltd., distributor Solco Healthcare US, LLC, and an NDC number 43547-275-03. The label is primarily blue and white with dosage and packaging details.*
FDA Label Image

Principal Display Panel – 10 mg Bottle Label (41d7651e B91a 4118 8719 Bf2f663d82a2 13)

Principal Display Panel – 10 mg Bottle Label (41d7651e B91a 4118 8719 Bf2f663d82a2 13)
Label for Donepezil HCl Tablets, USP 10 mg, oral film-coated tablets, 30 count. The label shows product name, strength, and dosage form. It includes storage instructions, manufacturer Zhejiang Huahai Pharmaceutical Co., Ltd., distributor Solco Healthcare US, LLC, and advises usual dosage reference to prescribing info. The design features blue, white, and yellow colors with a barcode and FDA-required 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.