Donepezil Hyrochloride
Product Images NDC 42582-311

Product Visual Gallery

This gallery contains 20 technical images submitted to the FDA as part of the official labeling for Donepezil Hyrochloride (NDC 42582-311). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Bi-coastal Pharma International Llc, 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

Image11 (Container Label 10mg)

Label for Donepezil Hydrochloride Tablets USP, 10 mg, in a package containing 30 film-coated tablets. Label includes NDC 42582-312-30, storage instructions at 20° to 25°C, and directs the pharmacist to dispense the patient information sheet. Manufactured by Vivimed Labs (Alathur) Private Limited in India and labeled by Bi-Coastal Pharma International LLC, Shrewsbury, NJ, USA. Barcode and lot/expiration date fields are present but not filled.*

FDA Label Image

Image10 (Container Label 5mg)

Label for Donepezil Hydrochloride 5 mg film-coated tablets, USP, containing 30 tablets in the package. The label includes NDC 42582-311-30 and indicates the product is for prescription use only. Manufactured by Vivimed Labs (Alathur) Pvt Ltd and labeled for Bi-Coastal Pharma International LLC.*

FDA Label Image

Donepezil 1

Donepezil Hydrochloride 10mg tablet label from Bi-Coastal Pharma International LLC. The image shows a single white round tablet imprinted with '10' on one side and 'NS' on the other. The tablet is placed on a white background with a shadow visible.*

FDA Label Image

Donepezil 2

Donepezil Hydrochloride 10mg tablet blister pack from Bi-Coastal Pharma International LLC. The image shows a silver foil blister sheet containing ten tablets arranged in two rows of five, each tablet coated and light brown in color with the imprint 'DCL 2410' visible on one side.*

FDA Label Image

Donepezil 3

Donepezil Hydrochloride 10mg tablet, white and round, imprinted with 'D10'. Shown on a plain background. No packaging or labeler information is visible in the image itself.*

FDA Label Image

Donepezil 4

Donepezil Hydrochloride 10mg film-coated tablets packaged in a white blister strip with four oval, white tablets. The label states the product name Donepezil Hydrochloride 10 mg and the labeler, Bi-Coastal Pharma International LLC.*

FDA Label Image

Figure 10

A cumulative percentage graph comparing patients treated with Donepezil hydrochloride 10 mg/day and placebo. The x-axis represents ADCS-ADL change from baseline, and the y-axis shows the cumulative percentage of patients. Two curves show differing distributions of changes in patient outcomes between the drug and placebo groups.*

FDA Label Image

Figure 11

A line graph showing the SIB (Severe Impairment Battery) change from baseline over 24 weeks of drug treatment for Donepezil hydrochloride at doses of 10 mg/day and 23 mg/day. The y-axis represents SIB change from baseline in least squares mean (±SE), ranging from -3 to 5. The x-axis shows weeks of drug treatment at 0, 6, 12, 18, and 24 weeks. Two lines depict clinical outcomes, with the 23 mg/day dose showing greater clinical improvement compared to the 10 mg/day dose, which remains near baseline values.*

FDA Label Image

Figure 12

A cumulative percentage plot showing patient responses to Donepezil hydrochloride at 10 mg/day and 23 mg/day doses. The x-axis represents SIB change from baseline, and the y-axis shows the cumulative percentage of patients. Two curves compare the effects of the two doses across the patient population.*

FDA Label Image

Figure 13

A bar chart comparing the percentage of patients by CIBIC-Plus Rating categories for Donepezil hydrochloride at 10 mg/day and 23 mg/day doses. The x-axis shows patient improvement or worsening categories, and the y-axis shows the percentage of patients for each category.*

FDA Label Image

Figure 01

A line graph showing ADAS-cog mean change from baseline over 30 weeks of drug treatment for Donepezil Hydrochloride 10 mg/day, 5 mg/day, and placebo groups. The y-axis represents cognitive change ranging from clinical improvement to clinical decline. The x-axis shows weeks of treatment. The graph compares cognitive function outcomes for both dosages and placebo during the trial period.*

FDA Label Image

Figure 02

A cumulative percentage of patients chart showing changes from baseline in ADAS-cog scores for Donepezil hydrochloride 10 mg/day, 5 mg/day, and placebo groups. The horizontal axis represents change from baseline, and the vertical axis shows cumulative patient percentage. Lines depict different groups with 10 mg/day showing the highest improvement and placebo the least, with comparison thresholds at 7 points, 4 points, and no change.*

FDA Label Image

Figure 03

A bar chart showing the distribution of CIBIC-plus Ratings among patients treated with Donepezil hydrochloride 10 mg/day, 5 mg/day, and placebo. The x-axis categorizes patient outcomes from Markedly Improved to Markedly Worse, while the y-axis shows the percentage of patients. The chart compares these three groups across different outcome categories.*

FDA Label Image

Figure 04

A line graph depicting ADAS-cog mean change from baseline over 15 weeks of drug treatment. It compares Donepezil hydrochloride 10 mg/day, 5 mg/day, and placebo groups, showing clinical improvement trends over time, with error bars indicating ±SE values.*

FDA Label Image

Figure 05

A cumulative percentage of patients chart displaying the change from baseline in ADAS-cog scores for three treatment groups: Donepezil hydrochloride 10 mg/day, Donepezil hydrochloride 5 mg/day, and placebo. The x-axis shows the change from baseline, and the y-axis shows the cumulative percentage of patients. The chart includes annotations for 7 points, 4 points, and no change, with a table summarizing percentages of patients reaching those changes by treatment group.*

FDA Label Image

Figure 06

A bar chart showing the distribution of patients by CIBIC-plus rating categories for Donepezil Hydrochloride 10 mg/day, Donepezil Hydrochloride 5 mg/day, and placebo groups. The y-axis represents the percentage of patients, and the x-axis lists categories from Markedly Improved to Markedly Worse, illustrating patient responses to the treatments.*

FDA Label Image

Figure 07

A line graph comparing SIB (Severe Impairment Battery) change from baseline (mean ± SE) over 6 months of drug treatment between Donepezil Hydrochloride 10 mg/day and placebo groups. The y-axis ranges from -8 to 8 showing clinical improvement and decline, while the x-axis indicates months of treatment at 0, 3, and 6. Donepezil shows clinical improvement, whereas placebo shows decline over time.*

FDA Label Image

Figure 08

A cumulative percentage curve graph comparing Donepezil Hydrochloride 10 mg/day and placebo groups, showing SIB (Severe Impairment Battery) change from baseline on the x-axis and cumulative percentage of patients on the y-axis. The graph illustrates the distribution of SIB changes for both treatment and placebo groups over a range of values.*

FDA Label Image

Figure 09

A line chart showing the mean change from baseline in ADCS-ADL scores over a 6-month drug treatment period. The chart compares Donepezil Hydrochloride 10 mg/day to placebo, with the Y-axis indicating clinical improvement or decline and the X-axis representing months of treatment (0, 3, and 6). Error bars indicate standard error for each data point.*

FDA Label Image

Structure 1

Chemical structure diagram showing the molecular structure of the active ingredient, Donepezil Hydrochloride, featuring atoms and chemical bonds including nitro, methyl, and hydroxyl groups connected to a nitrogen-containing ring.*

* 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.