Donepezil Hydrochloride
Product Images NDC 62756-445

Product Visual Gallery

This gallery contains 19 technical images submitted to the FDA as part of the official labeling for Donepezil Hydrochloride (NDC 62756-445). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Sun Pharmaceutical Industries, 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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Spl-donepezil-figure-1 (Spl Donepezil Figure 1)

The image shows a figure depicting the Time-course of Change in ADAS-cog score for patients completing 24 weeks of treatment. The graph represents mean (+SE) of ADAS-cog score change from baseline for patients receiving Placebo, Donepezil Hydrochloride 5 mg/day and Donepezil Hydrochloride 10 mg/day. The X-axis represents weeks of drug treatment and the Y-axis represents the ADAS-cog score change from baseline. It displays clinical improvement and clinical decline.*

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Spl-donepezil-figure-10 (Spl Donepezil Figure 10)

This is a figure that displays the cumulative percentage of patients completing 6 months of double-blind treatment with either a placebo or donepezil hydrochloride, based on particular changes from baseline in ADCS-ADL-Severe scores. There is also a chart with a progressive scale from -20 to +15 that shows the change from baseline in ADCS-ADL.*

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Spl-donepezil-figure-12 (Spl Donepezil Figure 12)

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Spl-donepezil-figure-13 (Spl Donepezil Figure 13)

This is a graph showing the frequency distribution of CIBIC-plus scores at week 24 for patients taking Donepezil Hydrochloride 23 mg/day and 10 mg/day for the treatment of a certain condition. The scores are categorized into "Markedly Improved," "Moderately Improved," "Minimally Improved," "No Change," "Minimally Worse," "Moderately Worse," and "Markedly Worse."*

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Spl-donepezil-figure-2 (Spl Donepezil Figure 2)

The figure shows the percentage of patients completing 24 weeks of a double-blind treatment with different changes from baseline ADAS-cog scores. The study involved a placebo group, a 5 mg/day Donepezil Hydrochloride group, and a 10 mg/day Donepezil Hydrochloride group. The percentages of randomized patients who completed the study were 80%, 85%, and 68% for placebo, 5 mg/day, and 10 mg/day respectively. The changes in ADAS-cog scores range from -7 to 0 with increments of 4 points. The cumulative percentage of patients completing the study is shown on the y-axis, while the changes from baseline are shown on the x-axis. This figure provides a visual representation of the effectiveness of the treatment in improving cognitive function in patients.*

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Spl-donepezil-figure-3 (Spl Donepezil Figure 3)

The figure shows the frequency distribution of CIBIC-plus scores after 24 weeks. The x-axis represents the categories of CIBIC-plus rating, while the y-axis represents the percentage of patients. The scores are categorized as markedly improved, moderately improved, minimally improved, no change, minimally worse, moderately worse, and markedly worse. The distribution is shown for patients on placebo, those on Donepezil Hydrochloride 5 mg/day, and those on Donepezil Hydrochloride 10 mg/day.*

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Spl-donepezil-figure-4 (Spl Donepezil Figure 4)

The text describes a figure labeled as Figure 4, which presents the time-course of change in ADAS-cog score for patients who completed a 15-week study. The figure compares the ADAS-cog score change from baseline and the mean between placebo and donepezil hydrochloride at the doses of 5mg/day and 10 mg/day. There is also a clinical improvement section, a decline section, and a placebo label on the chart. Therefore, this text provides information on a clinical study and its results.*

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Spl-donepezil-figure-5 (Spl Donepezil Figure 5)

This is a chart showing the cumulative percentage of patients in each treatment group who completed a study and had specified changes from baseline ADAS-cog scores. The treatment groups were placebo, 5 mg/day of Donepezil Hydrochloride, and 10 mg/day of Donepezil Hydrochloride. The chart includes three lines showing the changes of 7 points, 4 points, or no change in ADAS-cog scores, and the percentages of patients in each treatment group who had each change.*

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Spl-donepezil-figure-6 (Spl Donepezil Figure 6)

This is a chart showing the percentage of patients who have been given different dosages of Donepezil Hydrochloride and Placebo, and their corresponding levels of improvement according to the CIBIC-plus rating.*

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Spl-donepezil-figure-7 (Spl Donepezil Figure 7)

The text describes a figure showing graphically the time course of change from baseline in SIB (Severe Impairment Battery) score for patients who completed 6 months of treatment. The graph compares the effect of Donepezil Hydrochloride to a Placebo for the course of the treatment. The X-axis represents the months of drug treatment, and the Y-axis represents the SIB score changes. The graph shows a clinical improvement of the SIB scores for patients who received Donepezil Hydrochloride compared to patients who received Placebo. The figure also indicates a significant clinical decline from baseline for those receiving a Placebo.*

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Spl-donepezil-figure-8 (Spl Donepezil Figure 8)

The text presents a figure numbered 8 demonstrating the cumulative percentage of patients who completed six months of double-blind treatment with particular changes from baseline in SIB (Severe Impairment Battery) Scores. Both placebo and Donepezil Hydrochloride 10mg/day are being compared against each other. The text also shows a horizontal line divided into different intervals and negative values representing the percentage of changes in SIB scores.*

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Spl-donepezil-figure-9 (Spl Donepezil Figure 9)

This is a figure (Figure 9) displaying the time course of change from baseline in ADCS-ADL-Severe score for patients who completed 6 months of treatment. The mean is represented on the graph with the standard error (SE). The treatment options are Donepezil Hydrochloride 10 mg/day and Placebo. The graph shows a decline in the clinical score during the baseline and improvement during clinical treatment. The text does not provide more information.*

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Spl-donepezil-figure11 (Spl Donepezil Figure11)

This is a graph that shows the time-course of the change in SIB (Severe Impairment Battery) score for patients over a period of 24 weeks of treatment with Donepezil Hydrochloride 23 mg/day and 10 mg/day. The graph shows the LS mean (+ SE) (least-squares mean with standard error) scores for each treatment. The scores range from clinical improvement to decline compared to baseline.*

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Spl-donepezil-label-10mg (Spl Donepezil Label 10mg)

Each tablet of this medicine called Donepezil Hydrochloride Tablets, USP contains 10 mg of donepezil hydrochloride, USP. It is advised to refer the accompanying prescribing information for the usual dosage. The tablets need to be stored in a tight container and kept between the temperatures of 20 to 25°C (68 to 77°F), with permissible excursions between 15 to 30°C (59 to 86°F) as per USP Controlled Room Temperature guidelines. The batch referred to is not specified. This drug is exclusively for Rx only and comes in a pack of 30 tablets. The patient Information Sheet needs to be dispensed separately by the pharmacist. The drug is manufactured by Sun Pharmaceutical Industries Limited in India and distributed by Sun Pharmaceutical Industries, Inc. in Cranbury, NJ 08512.*

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Spl-donepezil-label-23mg (Spl Donepezil Label 23mg)

Each tablet of this medication contains 23mg of donepezil hydrochloride, a drug used to treat Alzheimer's disease. The usual dosage instructions are not included and should be obtained from the accompanying prescription information. It is recommended to store the tablets in tightly sealed containers at a temperature between 20°C and 25°C, with a permissible range of 15°C and 30°C. The tablets are dispensed with a provided patient information leaflet and are only available with a prescription. The manufacturer of these tablets is Sun Pharmaceutical Industries, based in India. The rest of the text contains logistical information specific to distribution and labeling.*

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Spl-donepezil-label-5mg (Spl Donepezil Label 5mg)

This is a description for Donepezil Hydrochloride Tablets, USP, containing 5 mg per film-coated tablet. It is a prescription-only drug and should be stored in a tight container at a temperature between 20°C to 25°C. The usual dosage information can be obtained from the accompanying prescribing information. Sun Pharmaceutical Industries is the distributor, and the drug is manufactured by Sun Pharmaceutical Industries Limited. There is a patient information sheet provided separately that the pharmacist should dispense. The rest of the text contains product codes and batch information.*

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Spl-donepezil-sb-10mg (Spl Donepezil Sb 10mg)

This text is a product label for Donepezil Hydrochloride Tablets, USP. This medication is intended for in-institution use only and is contained in a package that is not child-resistant. The medication should be stored at a controlled temperature and usage should follow the accompanying prescribing information. The tablets are individually blister sealed and should not be used if the seal is damaged or broken. The manufacturer is Sun Pharmaceutical Industries Limited and the distributor is Sun Pharmaceutical Industries, Inc. The NDC number is 62756-445-64.*

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Spl-donepezil-sb-5mg (Spl Donepezil Sb 5mg)

This is a pharmaceutical product description for Donepezil Hydrochloride Tablets, USP. The product is available in a 30 tablet unit-dose package that is not child-resistant. It is for in-institution use only and should be stored between 20 and 25°C. Each film-coated tablet contains 5 mg of donepezil hydrochloride, which should be taken as per accompanying prescribing information. The tablets come in blister-sealed packs, and the pharmacist should dispense a patient information sheet separately.*

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Spl-donepezil-structure (Spl Donepezil Structure)

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.