Dapagliflozin Tablet, Film Coated
Product Images NDC 50090-7056

Product Visual Gallery

This gallery contains 17 technical images submitted to the FDA as part of the official labeling for Dapagliflozin (NDC 50090-7056). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by A-s Medication Solutions, 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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Figure_4 (Figure 4)

A line graph comparing the percentage of patients with an event over 60 months from randomization between Dapagliflozin and placebo groups. The x-axis shows months from 0 to 60, and the y-axis shows the percentage of patients with the event. The graph includes data on patients at risk at various time points for both groups, with Dapagliflozin depicted as a solid line and placebo as a dashed line, showing a lower event percentage for Dapagliflozin throughout the timeline.*

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Figure_5 (Figure 5)

A line graph showing the percentage of patients with an event over months from randomization, comparing Dapagliflozin and placebo groups. The x-axis represents months (0 to 60) and the y-axis shows patients with events (%). Two lines indicate patient event rates, with a patient count at risk table displayed below for both groups across time points.*

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Dapagliflozin Chemical Structure (Dapagliflozin Struct)

Chemical structure of dapagliflozin, shown with its molecular components including a chlorine-substituted aromatic ring and sugar-like moiety, as well as associated molecules such as ethanol and water of hydration.*

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Figure_1 (Farxiga Fig1)

A scatter plot and fitted curve graph showing the relationship between dapagliflozin dose (mg) on a logarithmic x-axis and changes from baseline (CFB) in 24-hour urinary glucose (g) on the y-axis. The plot includes observed values and fitted lines for healthy subjects and subjects with Type 2 Diabetes Mellitus (T2DM).*

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Figure_10a (Figure 10a)

A forest plot showing the hazard ratios (HR) with 95% confidence intervals (CI) for various characteristics comparing dapagliflozin versus placebo. It includes subgroups based on age, sex, race, geographic region, NYHA class, NT-proBNP levels, prior hospitalization for heart failure, MRA use at baseline, type 2 diabetes status, atrial fibrillation or flutter at enrollment, main etiology of heart failure, BMI, and baseline eGFR. The plot shows point estimates and confidence intervals for each subgroup's composite primary endpoint outcomes.*

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Figure_10b (Figure 10b)

A forest plot chart comparing dapagliflozin and placebo groups across various characteristics such as age, sex, race, geographic region, NYHA class, NT-proBNP levels, diabetes status, atrial fibrillation, BMI, baseline eGFR, and systolic blood pressure. The chart shows hazard ratios with 95% confidence intervals, indicating the relative effect of dapagliflozin compared to placebo for these subgroups.*

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Figure_11 (Figure 11 01)

A forest plot comparing hazard ratios (HR) with 95% confidence intervals (CI) for different left ventricular ejection fraction (LVEF) percentage categories across two studies, DAPA-HF and DELIVER. The plot shows HR values for dapagliflozin versus placebo, indicating relative outcomes by category, with a horizontal axis ranging from 0.5 to 2.0, where values less than 1 favor dapagliflozin and values greater than 1 favor placebo.*

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Figure_8b (Figure 8b)

A line graph comparing the percentage of patients with an event over 36 months between dapagliflozin and placebo groups. The graph shows two lines: one solid for dapagliflozin and one dashed for placebo, with patient numbers at risk provided below the x-axis. The hazard ratio (HR) with 95% confidence interval is noted as 0.88 (0.74, 1.05), illustrating comparative event incidence over time.*

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Figure-9b (Figure 9b 01)

A Kaplan-Meier curve comparing the percentage of patients with an event over 36 months from randomization between dapagliflozin and placebo groups. The y-axis shows percentage of patients with event, and the x-axis shows months from randomization. Numeric data below the x-axis indicate numbers of patients at risk at various time points for both groups.*

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Figure_2 (Image 01)

A line graph showing adjusted mean change from baseline in HbA1c (%) over 24 study weeks comparing Dapagliflozin 10 mg with Metformin, Dapagliflozin 10 mg alone, and Metformin alone. The x-axis represents study weeks and the y-axis shows HbA1c change. The graph includes a separate panel on the right displaying Week 24 (LOCF) values with error bars for 95% confidence intervals.*

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Figure_3 (Image 02)

This line graph presents adjusted mean percentage changes from baseline in HbA1c over 24 weeks for two groups: Placebo + Metformin and Dapagliflozin 10 mg + Metformin. The x-axis shows study weeks, while the y-axis depicts HbA1c percent change. The graph includes longitudinal data with error bars for Week 24 (LOCF), comparing the treatment effects on HbA1c levels over time.*

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Figure_6 (Image 03)

A line graph comparing the percentage of patients with an event over time (up to 32 months) between Dapagliflozin and placebo groups. The graph shows fewer patients with events in the Dapagliflozin group versus placebo. Labels indicate hazard ratio (HR) 0.61 with 95% confidence interval (0.51, 0.72) and a P-value less than 0.0001. Patient numbers at risk for both groups are listed below the x-axis.*

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Figure_7a (Image 04)

A line chart depicting the percentage of patients with events over months from randomization, comparing Dapagliflozin versus placebo. The x-axis shows time in months (0 to 36), and the y-axis shows the percentage of patients with events (0-30%). Two lines represent the groups: Dapagliflozin (solid line) and placebo (dashed line). Patient counts at risk are displayed below the x-axis at various time points.*

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Figure-7b (Image 05)

A line graph comparing the percentage of patients with an event over time between Dapagliflozin and placebo groups, measured in months from randomization. The graph shows two lines: a solid line for Dapagliflozin and a dashed line for placebo, with the placebo group having a higher event rate. The chart includes patients at risk numbers at various time points and reports a hazard ratio (HR) of 0.82 with a 95% confidence interval and a p-value of 0.0008.*

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Figure-8a (Image 06)

A Kaplan-Meier plot comparing the percentage of patients with an event over months from randomization between Dapagliflozin and Placebo groups. The y-axis shows patients with events in percentage, while the x-axis indicates months from 0 to 36. The graph includes patient risk numbers over time and statistical values for hazard ratio and p-value for Dapagliflozin versus placebo.*

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Figure-9a (Image 07)

A line graph depicting the percentage of patients with an event over months from randomization, comparing Dapagliflozin and Placebo groups. The graph shows two curves, with the Placebo group (dashed line) having a higher event rate over time than the Dapagliflozin group (solid line). Below the graph is a table of patients at risk at various time points for both groups. The hazard ratio (HR) comparing Dapagliflozin to Placebo is 0.70 (95% CI: 0.59 to 0.83).*

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Label Image (Lbl500907056)

Label for DAPAGLIFLOZIN 5 mg film-coated oral tablets by A-S Medication Solutions. The label includes lot number 7214-0 and states each tablet contains 5 mg of dapagliflozin propanediol. The package contains 30 tablets with storage instructions to keep between 68 to 77 degrees Fahrenheit. Distributor information for A-S Medication Solutions in Libertyville, Illinois is also shown.*

* 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.