Donepezil Hydrochloride Tablet, Film Coated
Product Images NDC 13668-102

16 FDA label images from Torrent Pharmaceuticals Limited · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 16 technical images submitted to the FDA as part of the official labeling for Donepezil Hydrochloride (NDC 13668-102). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Torrent Pharmaceuticals 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

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De82e6d7 F231 449a A2aa 91e26eb50774 01
Chemical structure of Donepezil Hydrochloride, showing its molecular components including methoxy groups, piperidine ring, and a benzyl moiety connected with hydrochloride.*
FDA Label Image

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De82e6d7 F231 449a A2aa 91e26eb50774 02
A line graph showing ADAS-cog change from baseline mean (±SE) on the y-axis over 30 weeks of drug treatment on the x-axis. It compares Donepezil Hydrochloride Tablets 10 mg/day, 5 mg/day, and placebo. The graph indicates clinical improvement with negative changes and clinical decline with positive changes, illustrating that patients on Donepezil showed less decline than those on placebo over the study period.*
FDA Label Image

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De82e6d7 F231 449a A2aa 91e26eb50774 03
A cumulative percentage graph showing patient response to Donepezil Hydrochloride tablets at 5 mg/day and 10 mg/day doses compared to placebo, plotted against change from baseline in ADAS-cog score. The graph includes data points for the percentage of patients achieving 7-point, 4-point, and no change, with an inset table summarizing the percentages of patients in each treatment group showing changes in ADAS-cog scores of -7, -4, and 0.*
FDA Label Image

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De82e6d7 F231 449a A2aa 91e26eb50774 04
A bar chart titled 'CIBIC-plus Rating' showing the percentage of patients across treatment groups for Donepezil Hydrochloride Tablets 10 mg/day, 5 mg/day, and placebo. The x-axis lists patient improvement categories from 'Markedly Improved' to 'Markedly Worse,' while the y-axis shows the percentage of patients ranging from 0 to 50%. Bars represent patient distribution in each category for the three groups, with 10 mg/day and 5 mg/day donepezil groups generally showing higher percentages of no change and less worsening compared to placebo.*
FDA Label Image

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De82e6d7 F231 449a A2aa 91e26eb50774 05
A line graph depicting the mean change from baseline in ADAS-cog scores over weeks of drug treatment up to 15 weeks for Donepezil Hydrochloride Tablets at 10 mg/day and 5 mg/day doses, compared to placebo. The vertical axis shows ADAS-cog change (mean ±SE) with clinical improvement and decline indicated. The horizontal axis represents weeks of drug treatment, with a marked placebo phase after week 12. Donepezil 10 mg/day shows the greatest clinical improvement followed by 5 mg/day, while placebo shows minimal change.*
FDA Label Image

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De82e6d7 F231 449a A2aa 91e26eb50774 06
A line graph showing cumulative percentages of patients plotted against change from baseline in ADAS-cog scores. It compares Donepezil Hydrochloride Tablets 10 mg/day, 5 mg/day, and placebo groups. The graph highlights points corresponding to 7, 4, and no change, with an inset table summarizing percentages of patients reaching these ADAS-cog score changes by treatment group.*
FDA Label Image

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De82e6d7 F231 449a A2aa 91e26eb50774 07
A bar chart showing the distribution of patients by CIBIC-plus Rating categories for Donepezil Hydrochloride Tablets at 10 mg/day, 5 mg/day, and placebo groups. The x-axis shows CIBIC-plus ratings from Markedly Improved to Markedly Worse, and the y-axis shows the percentage of patients. The chart compares patient outcome percentages across the three treatments visually.*
FDA Label Image

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De82e6d7 F231 449a A2aa 91e26eb50774 08
A line graph showing the SIB (Severe Impairment Battery) change from baseline mean (±SE) over 0, 3, and 6 months of drug treatment. The graph compares Donepezil Hydrochloride Tablets 10 mg/day against placebo, illustrating clinical improvement for Donepezil and clinical decline for placebo over time.*
FDA Label Image

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De82e6d7 F231 449a A2aa 91e26eb50774 09
A cumulative percentage of patients graph comparing Donepezil Hydrochloride Tablets 10 mg/day with placebo. The x-axis shows SIB change from baseline, ranging from -75 to +30, while the y-axis shows cumulative percentage of patients from 0 to 100%. Solid circles represent Donepezil, and open squares represent placebo, showing a greater leftward shift for Donepezil indicating larger SIB score improvements.*
FDA Label Image

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De82e6d7 F231 449a A2aa 91e26eb50774 10
A line graph showing the time course change from baseline in ADCS-ADL-Severe score over 6 months for patients treated with Donepezil Hydrochloride Tablets 10 mg/day versus placebo. The x-axis represents months of drug treatment (0, 3, 6), and the y-axis represents the mean change from baseline with standard error. The graph illustrates a smaller decline in ADCS-ADL score for the Donepezil group compared to placebo, with annotations indicating clinical improvement and decline directions.*
FDA Label Image

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De82e6d7 F231 449a A2aa 91e26eb50774 11
A cumulative percentage graph comparing Donepezil Hydrochloride 10 mg/day tablets to placebo. The x-axis shows ADCS-ADL change from baseline, while the y-axis shows the cumulative percentage of patients. The graph plots two curves showing patient distribution based on their ADCS-ADL change scores.*
FDA Label Image

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FDA Label Image

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FDA Label Image

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Donepezil Hydrochloride 5 mg film-coated tablets packaging label by Torrent Pharmaceuticals Limited. The label indicates a 30 tablet count with instructions to dispense an accompanying patient information sheet. Storage conditions, manufacturer information, and that the product is Rx only are also shown.*
FDA Label Image

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De82e6d7 F231 449a A2aa 91e26eb50774 15
Donepezil Hydrochloride 10 mg film-coated tablets label from Torrent Pharmaceuticals Limited. The label states the strength as 10 mg, contains 30 tablets, and includes storage instructions and dosage information. It highlights the drug as prescription-only (Rx only) and shows the NDC number 13668-103-30. The label also advises pharmacists to dispense the accompanying patient information sheet.*
FDA Label Image

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Label for Donepezil Hydrochloride Tablets USP 10 mg, film-coated oral tablets. The label indicates a package of 30 tablets with NDC 13668-103-30. It includes storage instructions, dispensing requirements, and pharmacy directions to provide the patient information sheet. The labeler is Torrent Pharmaceuticals Limited, India, with manufacturing also noted in New Jersey, USA.*

* 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.