Donepezil Hydrochloride
Product Images NDC 55111-356

Product Visual Gallery

This gallery contains 15 technical images submitted to the FDA as part of the official labeling for Donepezil Hydrochloride (NDC 55111-356). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Dr. Reddys Laboratories 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

Carton1 (Carton1)

Packaging label for Donepezil Hydrochloride Tablets USP, 5 mg, manufactured by Dr. Reddy's Laboratories Limited. The label states the quantity as 100 tablets (10 x 10 unit-dose) and includes instructions to dispense with patient package insert. Storage instructions and usual dosage advisory are also present, along with a barcode and NDC number 55111-356-78.*

FDA Label Image

Carton2 (Carton2)

Packaging label for Donepezil Hydrochloride Tablets USP, 10 mg by Dr. Reddys Laboratories Limited. The label indicates the product contains 100 film-coated tablets in unit-dose packaging (10 blister cards with 10 tablets each). The label includes storage instructions and dosage advisory, along with the NDC 55111-357-78. Manufactured in India by Dr. Reddy's Laboratories Limited.*

FDA Label Image

Container1 (Container1)

Donepezil Hydrochloride Tablets USP, 5 mg, label showing a blister pack or strip packaging for 30 tablets by Dr. Reddys Laboratories Limited. The label includes directions for pharmacists to dispense with patient package insert and storage instructions at 20-25°C (68-77°F). Barcodes, NDC 55111-356-30, and manufacturing details are also visible.*

FDA Label Image

Container2 (Container2)

Donepezil Hydrochloride Tablets USP, 10 mg by Dr. Reddys Laboratories Limited. The label indicates 30 tablets in the package with each film-coated tablet containing 10 mg of donepezil. It includes storage instructions to keep the product at 20°-25°C (68°-77°F) in a controlled room temperature environment. The label also states that it is Rx only and advises dispensing in the original container with a pharmacist note to dispense with the patient package insert.*

FDA Label Image

Figure1 (Figure1)

A line graph showing clinical improvement measured by ADAS-cog change from baseline over 24 weeks of drug treatment, comparing Donepezil hydrochloride 10 mg/day, 5 mg/day, and placebo. The x-axis represents weeks of treatment, and the y-axis shows ADAS-cog change from baseline, with clinical improvement indicated by a negative change. Data points include error bars.*

FDA Label Image

Figure10 (Figure10)

A cumulative percentage graph showing patient response comparing Donepezil 10 mg/day to placebo. The x-axis represents ADCS-ADL change from baseline, and the y-axis shows cumulative percentage of patients, illustrating the distribution of patient outcomes for both groups.*

FDA Label Image

Figure2 (Figure2)

A cumulative percentage of patients chart showing change from baseline on the x-axis and cumulative percentage on the y-axis for Donepezil hydrochloride at 5 mg/day and 10 mg/day doses compared to placebo. A table embedded in the graph displays the percentage of patients in each treatment group experiencing changes of -7, -4, and 0 in ADAS-cog scores.*

FDA Label Image

Figure3 (Figure3)

A bar graph comparing the percentage of patients showing various degrees of change, including markedly improved, moderately improved, minimally improved, no change, minimally worse, moderately worse, and markedly worse. The comparison is among three groups: Donepezil 10 mg/day, Donepezil 5 mg/day, and placebo.*

FDA Label Image

Figure4 (Figure4)

A line graph showing mean change from baseline in ADAS-cog scores over 12 weeks of treatment with Donepezil hydrochloride at doses of 5 mg/day and 10 mg/day compared to placebo. The x-axis represents weeks of drug treatment and placebo, while the y-axis indicates change in scores with clinical improvement and decline labeled. Data points include error bars for standard error.*

FDA Label Image

Figure5 (Figure5)

A cumulative percentage plot showing changes from baseline in ADAS-cog scores for three treatment groups: Donepezil 10 mg/day, Donepezil 5 mg/day, and placebo. The x-axis represents change from baseline, and the y-axis shows the cumulative percentage of patients, with notable points marked where 7 and 4 points improvement occur.*

FDA Label Image

Figure6 (Figure6)

A bar chart comparing percentage of patients across different categories of Clinical Global Impression-Improvement (CGI-I) scores for three groups: Donepezil 5 mg/day, Donepezil 10 mg/day, and Placebo. Categories range from markedly improved to markedly worse.*

FDA Label Image

Figure7 (Figure7)

A line graph showing SIB (Severe Impairment Battery) change from baseline (mean ± SE) over 6 months of drug treatment. It compares Donepezil 10 mg/day and placebo groups, illustrating clinical improvement and decline trends over time.*

FDA Label Image

Figure8 (Figure8)

A cumulative percentage of patients graph comparing Donepezil hydrochloride 10 mg/day versus placebo, showing the distribution of SIB change from baseline. The x-axis represents the SIB change from baseline, and the y-axis the cumulative percentage of patients, illustrating the drug's effect relative to placebo.*

FDA Label Image

Figure9 (Figure9)

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

FDA Label Image

Structure (Structure)

Chemical structure diagram of donepezil hydrochloride showing the molecular arrangement with labeled chemical groups including methoxy groups, a ketone group, and a hydrochloride hydrate component.*

* 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.