Donepezil Hydrochloride
Product Images NDC 71093-127

Product Visual Gallery

This gallery contains 22 technical images submitted to the FDA as part of the official labeling for Donepezil Hydrochloride (NDC 71093-127). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aci Healthcare Usa, 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.

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Container Label-10mg1000s (10mg 1000s)

Donepezil Hydrochloride 10 mg tablets label showing USP designation, strength, and quantity of 1000 tablets. The label includes storage instructions, manufacturer Elysium Pharmaceuticals (India), and distributor ACI Healthcare USA, Inc. Barcode and regulatory text are present, with a green, red, and white color scheme.*

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Container Label-10mg30s (10mg 30s)

Donepezil Hydrochloride 10 mg tablets label displaying the product name, strength, dosage form, and quantity of 30 tablets. The label includes storage instructions, dosage and use notes, and manufacturer information for Elysium Pharmaceuticals Limited. Distributed by ACI Healthcare USA, Inc., the label also features a barcode and highlights the necessity to dispense the Medication Guide separately to each patient.*

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Container Label-10mg500s (10mg 500s)

Donepezil Hydrochloride 10 mg Tablets, USP label from ACI Healthcare USA, Inc. The label states the strength (10 mg) and quantity (500 tablets). It includes storage instructions, medication guide dispensing note, manufacturer and distributor information, and a barcode. The label is primarily green and white with red accents.*

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Container Label-10mg90s (10mg 90s)

Donepezil Hydrochloride Tablets USP 10 mg packaging label from ACI Healthcare USA, Inc. The label shows a green and red design, indicating a bottle containing 90 tablets. It includes storage instructions, medication warnings, and a barcode.*

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Container Label-5mg1000s (5mg 1000s)

Donepezil Hydrochloride Tablets, USP packaging label showing 5 mg strength with a count of 1000 tablets. The label states prescription use only and includes storage instructions, manufacturer details (Elysium Pharmaceuticals Limited, India), and distributor information (ACI Healthcare USA, Inc.). The label also highlights a pharmacist note to dispense the Medication Guide separately.*

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Container Label-5mg30s (5mg 30s)

Donepezil Hydrochloride 5 mg tablets label from ACI Healthcare USA, Inc. The label states the product name, strength, dosage form, and quantity of 30 tablets. It includes storage instructions, dosage use notes, manufacturer and distributor information, and a prominent ACI Healthcare USA logo. The label also has an NDC code and a note about a no varnish zone for batch details.*

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Container Label-5mg500s (5mg 500s)

Donepezil Hydrochloride 5 mg tablets, USP label from ACI Healthcare USA, Inc. The label indicates the product contains 500 tablets. It includes dosage storage instructions and manufacturer information, with a barcode and clear identification of the active ingredient strength.*

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Container Label-5mg90s (5mg 90s)

Donepezil Hydrochloride Tablets, USP 5 mg, bottle label from ACI Healthcare USA, Inc., showing dosage strength, tablet count of 90, and storage instructions. The label includes directions for dispensing the Medication Guide and warning to keep out of reach of children. Manufacturer and distributor information is also visible.*

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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 depicting the mean change from baseline in ADAS-cog scores over 30 weeks of drug treatment. The graph compares Donepezil Hydrochloride at 10 mg/day, 5 mg/day, and placebo, showing clinical improvement or decline over time with error bars representing standard error.*

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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 line graph showing the cumulative percentage of patients plotted against ADCS-ADL change from baseline. Two lines compare Donepezil Hydrochloride 10 mg/day and placebo groups, illustrating patient response differences over the measured changes.*

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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)

Line graph depicting SIB change from baseline (LS mean ±SE) over 24 weeks of treatment with Donepezil Hydrochloride at doses of 23 mg/day and 10 mg/day. The vertical axis shows clinical improvement or decline, and the horizontal axis shows weeks of treatment. Data points for both doses track the drug's impact on SIB scores over time.*

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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 distribution plot displaying the percentage of patients versus SIB (Severe Impairment Battery) change from baseline, comparing Donepezil Hydrochloride 23 mg/day and 10 mg/day doses. The x-axis represents SIB change from baseline, and the y-axis shows the cumulative percentage of patients.*

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

A bar chart comparing the percentage of patients by CIBIC-plus rating for Donepezil Hydrochloride at two dosages: 23 mg/day and 10 mg/day. The categories on the x-axis include Markedly Improved, Moderately Improved, Minimally Improved, No Change, Minimally Worse, Moderately Worse, and Markedly Worse. The y-axis represents the percentage of patients, with various trends illustrated for each dosage group.*

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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 change from baseline in ADAS-cog scores among patients treated with Donepezil Hydrochloride at 5 mg and 10 mg doses versus placebo. The x-axis represents change from baseline scores, and the y-axis shows cumulative percentage of patients. The graph includes a table summarizing percentage of patient improvement at various threshold points for each treatment group.*

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

A bar graph depicting the percentage of patients by CIBIC-plus rating categories for Donepezil Hydrochloride at 5 mg/day, 10 mg/day, and placebo groups. The categories range from markedly improved to markedly worse, showing comparative patient response distributions.*

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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 change from baseline over weeks of drug treatment comparing Donepezil Hydrochloride 10 mg/day, Donepezil Hydrochloride 5 mg/day, and placebo. The vertical axis shows change from baseline with clinical improvement and decline noted, and the horizontal axis indicates weeks of drug treatment. Error bars representing standard error are included for each data point.*

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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)

Cumulative percentage of patients plotted against change from baseline in a graph comparing Donepezil Hydrochloride 10 mg/day, 5 mg/day, and placebo. The graph includes treatment groups' changes in ADAS-cog scores at -7, -4, and 0 points. Donepezil 10 mg/day shows the highest cumulative percentage of patients with improvement, followed by 5 mg/day, and placebo the least.*

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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 rated on the CIBIC-plus scale, with categories from 'Markedly Improved' to 'Markedly Worse'. The chart contrasts three groups: Donepezil Hydrochloride 10 mg/day, Donepezil Hydrochloride 5 mg/day, and placebo, showing variations in patient outcomes across these treatment groups.*

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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 (Severe Impairment Battery) change from baseline over 6 months of drug treatment comparing Donepezil Hydrochloride 10 mg/day to placebo. The vertical axis measures SIB change with clinical improvement upwards and clinical decline downwards. Donepezil shows clinical improvement while placebo trends towards decline.*

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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 plot comparing patients treated with Donepezil Hydrochloride 10 mg/day versus placebo. The x-axis shows SIB change from baseline, while the y-axis shows cumulative percentage of patients. The graph depicts treatment effects over a range of SIB changes.*

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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 depicting mean change from baseline in ADCS-ADL scores over six months of drug treatment. Two lines compare Donepezil Hydrochloride 10 mg/day and placebo groups, showing scores declining over time with the placebo group exhibiting greater decline. The y-axis indicates clinical improvement or decline relative to baseline.*

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Chemical Structure (Donepezil Str)

Chemical structure of donepezil hydrochloride shown as a molecular diagram with aromatic rings, piperidine ring, methoxy groups, and hydrochloride indicated as .HCl.*

* 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.