Donepezil Hydrochloride Tablet, Film Coated
Product Images NDC 65862-326

Product Visual Gallery

This gallery contains 18 technical images submitted to the FDA as part of the official labeling for Donepezil Hydrochloride (NDC 65862-326). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aurobindo Pharma 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.

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Figure 1. Time-course Of The Change From Baseline In Adas-cog Score For Patients Completing 24 Weeks Of Treatment. (Donepezil Fig1)

A line graph illustrating clinical changes over 30 weeks measured by ADAS-cog scores from baseline. The graph compares Donepezil Hydrochloride at 10 mg/day and 5 mg/day doses against placebo, showing mean change with standard error bars over weeks of drug treatment, indicating clinical improvement or decline.*

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Figure 10. Cumulative Percentage Of Patients Completing 6 Months Of Double-blind Treatment With Particular Changes From Baseline In Adcs-adl-severe Scores. (Donepezil Fig10)

A cumulative percentage of patients line graph comparing Donepezil Hydrochloride 10 mg/day and placebo groups. The x-axis represents ADCS-ADL change from baseline, while the y-axis shows the cumulative percentage of patients. Donepezil patients exhibit a right-shifted curve indicating more improvement compared to placebo.*

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Figure 11. Time-course Of The Change From Baseline In Sib Score For Patients Completing 24 Weeks Of Treatment. (Donepezil Fig11)

A line graph showing SIB (Severe Impairment Battery) change from baseline over 24 weeks of drug treatment with Donepezil Hydrochloride at doses of 23 mg/day and 10 mg/day. The vertical axis represents the least squares mean change with standard error, indicating clinical improvement or decline, while the horizontal axis shows weeks of treatment.*

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Figure 12. Cumulative Percentage Of Patients Completing 24 Weeks Of Double-blind Treatment With Specified Changes From Baseline Sib Scores. (Donepezil Fig12)

A cumulative percentage graph showing patient response to Donepezil Hydrochloride at 10 mg/day and 23 mg/day doses. The x-axis represents the SIB (Severe Impairment Battery) change from baseline, ranging from +50 to -60, while the y-axis shows the cumulative percentage of patients from 0 to 100%. Two lines depict different dose groups, indicating shifts in SIB scores relative to baseline.*

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Figure 13. Frequency Distribution Of Cibic-plus Scores At Week 24. (Donepezil Fig13)

A bar chart comparing the percentages of patients across CIBIC-plus rating categories for Donepezil Hydrochloride at 23 mg/day and 10 mg/day doses. The x-axis shows categories from Markedly Improved to Markedly Worse, while the y-axis represents the percentage of patients. The chart visualizes patient outcome distribution for both dosage groups.*

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Package Label-principal Display Panel (5 mg (100 Tablet Bottle))

Donepezil Hydrochloride Tablets USP 5 mg film-coated tablets label by Aurobindo Pharma Limited. The label indicates 100 tablets per container and includes storage instructions, distributor information, and cautions to dispense in tight containers. The label also states "Rx only" and provides the NDC number.*

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Package Label-principal Display Panel (5 mg Blister Carton (10 x 10 Unit-dose))

Packaging label for Donepezil Hydrochloride Tablets USP 5 mg film-coated tablets. The label shows a package containing 100 tablets (10 x 10 unit dose) distributed by Aurobindo Pharma USA, Inc. The label includes storage instructions, dosage form, and NDC 65862-325-10.*

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Package Label-principal Display Panel (10 mg (100 Tablet Bottle))

Donepezil Hydrochloride Tablets USP 10 mg film-coated tablets label displaying dosage and packaging details. The label shows the NDC number 65862-326-01 and indicates the package contains 100 tablets. Distributed by Aurobindo Pharma USA, Inc., with manufacturing in India. Storage instructions and dispensing requirements are also included.*

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Package Label-principal Display Panel (10 mg Blister Carton (10 x 14 Unit-dose))

Label packaging for Donepezil Hydrochloride Tablets USP 10 mg, film-coated tablets in a unit dose package of 140 tablets (10 x 14). The label is marked Rx only and distributed by Aurobindo Pharma USA, Inc. The packaging includes storage instructions and a barcode, showing the NDC 65862-326-14.*

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Figure 2. Cumulative Percentage Of Patients Completing 24 Weeks Of Double-blind Treatment With Specified Changes From Baseline Adas-cog Scores. The Percentages Of Randomized Patients Who Completed The Study Were: Placebo 80%, 5 mg/day 85%, And 10 mg/day 68%. (Donepezil Fig2)

A cumulative percentage graph showing the change from baseline in ADAS-cog scores for patients treated with placebo, 5 mg/day Donepezil Hydrochloride, and 10 mg/day Donepezil Hydrochloride. The graph plots cumulative percentage of patients against the change from baseline, with a small inset table summarizing percentage changes at different score thresholds.*

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Figure 3. Frequency Distribution Of Cibic-plus Scores At Week 24. (Donepezil Fig3)

A bar chart comparing the percentage of patients by CIBIC-plus Rating categories among three groups: Donepezil Hydrochloride 10 mg/day, Donepezil Hydrochloride 5 mg/day, and Placebo. The categories range from Markedly Improved to Markedly Worse, showing varied patient outcomes across the treatment and placebo groups.*

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Figure 4. Time-course Of The Change From Baseline In Adas-cog Score For Patients Completing The 15-week Study. (Donepezil Fig4)

A line graph depicting ADAS-cog mean change from baseline over 15 weeks of drug treatment comparing Donepezil Hydrochloride 10 mg/day, 5 mg/day, and placebo. The x-axis shows weeks of treatment, including a placebo period after 12 weeks. The y-axis represents cognitive change, with upward indicating clinical improvement and downward clinical decline. Error bars indicate standard error.*

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Figure 5. Cumulative Percentage Of Patients With Specified Changes From Baseline Adas-cog Scores. The Percentages Of Randomized Patients Within Each Treatment Group Who Completed The Study Were: Placebo 93%, 5 mg/day 90%, And 10 mg/day 82%. (Donepezil Fig5)

A cumulative percentage of patients chart showing changes from baseline on the x-axis and cumulative percentage on the y-axis for Donepezil Hydrochloride 5 mg/day, 10 mg/day, and placebo groups. The graph includes vertical lines marking 7 points and 4 points change thresholds, with a table summarizing the percentage of patients in each treatment group achieving different levels of change in ADAS-cog scores.*

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Figure 6. Frequency Distribution Of Cibic-plus Scores At Week 12. (Donepezil Fig6)

A bar chart comparing the percentage of patients across different CIBIC-plus rating categories for Donepezil Hydrochloride 10 mg/day, 5 mg/day, and placebo groups. The categories include markedly improved, moderately improved, minimally improved, no change, minimally worse, moderately worse, and markedly worse.*

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Figure 7. Time Course Of The Change From Baseline In Sib Score For Patients Completing 6 Months Of Treatment. (Donepezil Fig7)

A line graph showing SIB change from baseline (Mean ± SE) over 6 months of drug treatment comparing Donepezil Hydrochloride 10 mg/day and placebo. The y-axis represents SIB change with clinical improvement above baseline and clinical decline below. The x-axis shows months of drug treatment (0, 3, and 6). Donepezil shows increasing improvement while placebo declines over time.*

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Figure 8. Cumulative Percentage Of Patients Completing 6 Months Of Double-blind Treatment With Particular Changes From Baseline In Sib Scores. (Donepezil Fig8)

A cumulative percentage graph comparing Donepezil Hydrochloride 10 mg/day with placebo. The x-axis shows SIB (Severe Impairment Battery) change from baseline, and the y-axis shows the cumulative percentage of patients. The graph highlights differences in patient response between the drug and placebo groups over a range of SIB scores.*

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Figure 9. Time Course Of The Change From Baseline In Adcs-adl-severe Score For Patients Completing 6 Months Of Treatment. (Donepezil Fig9)

A line graph showing the mean change from baseline in ADCS-ADL scores over 6 months of drug treatment. The graph compares Donepezil Hydrochloride 10 mg/day and placebo groups, indicating clinical improvement and decline over time with error bars representing standard error.*

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Chemical Structure (Donepezil Str)

Chemical structure of Donepezil Hydrochloride, showing the molecular arrangement including methoxy groups, a piperidine ring, and a phenyl group with associated hydrochloride salt.*

* 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.