Dapagliflozin Tablet, Film Coated
Product Images NDC 67877-608

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Dapagliflozin (NDC 67877-608). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Ascend Laboratories, 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

Dapa-10mg-10s-tab-a (Dapa 10mg 10s Tab A)

Dapagliflozin Tablets 10 mg film-coated tablets unit-dose packaging by Ascend Laboratories, LLC. The package contains 10 tablets (1 x 10 Unit-Dose). The label includes storage instructions, manufacturer details (Alkem Laboratories, India), and a barcode. The design features the product name and strength prominently on multiple panels.*

FDA Label Image

Dapa-10mg-500s-tab-a (Dapa 10mg 500s Tab A)

Dapagliflozin Tablets 10 mg film-coated oral tablets label from Ascend Laboratories, LLC. The label includes storage instructions, pharmacist dispensing guidelines, and a barcode. It indicates a 500-tablet count, Rx only status, and notes the manufacturer as Alkem Laboratories Ltd., India.*

FDA Label Image

Dapa-5mg-30s-tab-a (Dapa 5mg 30s Tab A)

Dapagliflozin Tablets 5 mg film-coated tablets label from Ascend Laboratories, LLC. The label includes storage instructions, NDC 67877-608-30, a barcode, and states the product contains 30 tablets. Manufactured by Alkem Laboratories Ltd., India, and distributed by Ascend Laboratories, LLC, Bedminster, NJ.*

FDA Label Image

Dapa-fig-1 (Dapa Fig 1)

A scatter plot comparing dapagliflozin dose (mg) on a logarithmic x-axis with change from baseline (CFB) in 24-hour urinary glucose (g) on the y-axis. Observed values for healthy subjects and those with type 2 diabetes mellitus (T2DM) are plotted with different symbols. Fitted response lines for both groups are also displayed, illustrating the glucose excretion response to increasing dapagliflozin doses.*

FDA Label Image

Dapa-fig-2 (Dapa Fig 2)

Line graph illustrating adjusted mean percentage change from baseline in HbA1c over 24 study weeks for treatment groups: Dapagliflozin 10 mg with Metformin, Dapagliflozin 10 mg alone, and Metformin alone. The x-axis shows study weeks, and the y-axis shows HbA1c percentage change. The graph includes data points and error bars with a legend distinguishing each treatment group.*

FDA Label Image

Dapa-fig-3 (Dapa Fig 3)

A longitudinal line graph comparing adjusted mean HbA1c percentage change from baseline over 24 study weeks between two groups: one receiving placebo plus metformin and another receiving 10 mg dapagliflozin plus metformin. The graph shows greater HbA1c reduction in the dapagliflozin group. A side panel displays adjusted mean changes with 95% confidence intervals at week 24 using last observation carried forward (LOCF).*

FDA Label Image

Dapa-fig-4 (Dapa Fig 4)

A line graph showing the percentage of patients with events over months from randomization, comparing dapagliflozin with placebo. The x-axis represents months from 0 to 60, and the y-axis shows patients with events (%) from 0 to 7. Two lines indicate event rates for dapagliflozin and placebo groups, with placebo generally higher. Patient numbers at risk are listed below the x-axis for each group at multiple time points.*

FDA Label Image

Dapa-fig-5 (Dapa Fig 5)

A line graph showing the percentage of patients with events over 60 months from randomization comparing Dapagliflozin to Placebo. The graph includes patient counts at risk below the timeline for each group and shows Dapagliflozin with a consistently lower event rate than Placebo throughout the study period.*

FDA Label Image

Dapa-str (Dapa Str)

Chemical structure of dapagliflozin showing its molecular framework with chlorine, hydroxyl groups, and ethoxy phenyl components. The diagram depicts the arrangement of atoms and bonds typical to the dapagliflozin molecule.*

* 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.