Dapagliflozin Tablet, Film Coated
Product Images NDC 0781-5990

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Dapagliflozin (NDC 0781-5990). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Sandoz 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.

FDA Label Image

10mgx30tablets (10 mgx30tablets)

Dapagliflozin Tablets 10 mg film-coated oral tablets packaging label by Sandoz Inc. The label states 30 tablets, with storage instructions and a warning to keep out of reach of children. Manufactured by Sandoz Private Ltd., India, for Sandoz Inc., Princeton, NJ.*

FDA Label Image

5mgx30tablets (5 mgx30tablets)

Dapagliflozin 5 mg film-coated tablets packaging label by Sandoz Inc. The label indicates a 30-tablet bottle with instructions to dispense the accompanying Medication Guide. It contains storage temperature details and a note about the inner seal. Manufactured by Sandoz Private Ltd., India for Sandoz Inc., Princeton, NJ.*

FDA Label Image

Chemicalstructure (Chemicalstructure)

Chemical structure of dapagliflozin, the active ingredient in the medication. The diagram shows the molecular arrangement and bonding of atoms characteristic of the dapagliflozin molecule.*

FDA Label Image

Figure-dapagliflozin-02 (Figure Dapagliflozin 02)

A line chart depicting adjusted mean change from baseline in HbA1c (%) over 24 weeks for three groups: Dapagliflozin 10 mg combined with Metformin, Dapagliflozin 10 mg alone, and Metformin alone. The graph includes data points at study weeks 0, 4, 8, 12, 16, 20, and 24, with a smaller inset showing Week 24 last observation carried forward (LOCF) values with 95% confidence intervals.*

FDA Label Image

Figure-dapagliflozin-03 (Figure Dapagliflozin 03)

A line graph displaying adjusted mean change in HbA1c (%) from baseline over a 24-week study period comparing Dapagliflozin 10 mg + Metformin versus Placebo + Metformin. The y-axis shows HbA1c change, and the x-axis shows study weeks. The graph includes a summary bar on the right side depicting mean changes and 95% confidence intervals at week 24 using LOCF analysis.*

FDA Label Image

Figure-dapagliflozin-04 (Figure Dapagliflozin 04)

A line graph showing the percentage of patients with events over months from randomization, comparing Dapagliflozin and placebo groups. The x-axis represents months from 0 to 60, and the y-axis represents the percentage of patients with events from 0% to 7%. Two lines indicate outcomes over time: a solid line for Dapagliflozin and a dashed line for placebo. The graph includes a table below listing the number of patients at risk at various time points for both groups.*

FDA Label Image

Figure-dapagliflozin-05 (Figure Dapagliflozin 05)

A Kaplan-Meier curve showing the percentage of patients with an event over time in months from randomization, comparing Dapagliflozin and placebo. The graph plots patients with event (%) on the y-axis and months on the x-axis. It includes patient numbers at risk for both groups at multiple time points up to 60 months. The placebo group shows a higher cumulative percentage of events compared to the Dapagliflozin group over the study period.*

FDA Label Image

Figure-dapagliflozin-01 (Dapagliflozin 01)

A scatter plot with dose-response curves showing the relationship between dapagliflozin dose (mg, logarithmic scale) and change from baseline (CFB) in 24-hour urinary glucose (g). Data points represent observed values for healthy subjects and subjects with type 2 diabetes mellitus (T2DM). Fitted trend lines for each group are also depicted, illustrating dose-dependent increases in urinary glucose excretion.*

* 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.