Dapagliflozin Tablet, Film Coated
Product Images NDC 50090-7057

Product Visual Gallery

This gallery contains 17 technical images submitted to the FDA as part of the official labeling for Dapagliflozin (NDC 50090-7057). 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 showing the percentage of patients with events over 60 months from randomization, comparing Dapagliflozin versus Placebo. The y-axis represents patients with events (%) and the x-axis shows months from randomization. Two lines are shown: one for Dapagliflozin and one for Placebo, with Placebo generally having a higher event rate over time. Numbers of patients at risk for each group are listed below the graph across various time points.*

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Figure_5 (Figure 5)

A Kaplan-Meier curve graph showing the percentage of patients with an event over months from randomization, comparing Dapagliflozin and Placebo groups. The graph includes a table of patients at risk at various time points for each group, indicating sample size during the study period up to 60 months.*

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Dapagliflozin Chemical Structure (Dapagliflozin Struct)

Chemical structure of dapagliflozin, showing its molecular components including a chlorophenyl group, glucose-derived moiety, and an associated ethanol and water molecule.*

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Figure_1 (Farxiga Fig1)

A scatter plot with fitted lines showing the relationship between Dapagliflozin dose (mg) on a logarithmic x-axis and change from baseline (CFB) in 24-hour urinary glucose (g) on the y-axis. Observed values are plotted for healthy subjects and subjects with type 2 diabetes mellitus (T2DM), with separate fitted trend lines for each group.*

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Figure_10a (Figure 10a)

A forest plot illustrating hazard ratios (HR) with 95% confidence intervals (CI) for various patient characteristics comparing Dapagliflozin versus placebo. The chart covers factors such as age, sex, race, geographic region, NYHA class, NT-proBNP levels, prior hospitalization for heart failure, MRA use, type 2 diabetes status, atrial fibrillation/flutter, main etiology of heart failure, BMI, and baseline eGFR. Data includes number of events and total patients per subgroup, showing Dapagliflozin's relative efficacy across diverse populations.*

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Figure_10b (Figure 10b)

A forest plot chart illustrating the hazard ratios with 95% confidence intervals for various characteristics comparing Dapagliflozin versus Placebo. The chart lists groups by age, sex, race, geographic region, NYHA class, NT-proBNP levels, subacute status, type 2 diabetes mellitus at enrollment, atrial fibrillation/flutter, BMI, baseline eGFR, and SBP at randomization. Each group's hazard ratio is depicted with a confidence interval on a horizontal scale indicating whether Dapagliflozin or placebo was better.*

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Figure_11 (Figure 11 01)

A forest plot comparing hazard ratios (HR) with 95% confidence intervals (CI) for dapagliflozin versus placebo across different left ventricular ejection fraction (LVEF) percentage categories in two studies (DAPA-HF and DELIVER). The plot shows HR values and participant counts for dapagliflozin and placebo groups, with a horizontal axis ranging from 0.5 to 2.0 indicating the relative effectiveness of the treatments.*

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Figure_8b (Figure 8b)

A Kaplan-Meier curve chart comparing the percentage of patients with events over 36 months between Dapagliflozin and Placebo groups. The x-axis shows months from randomization and the y-axis shows patients with events (%). Patient numbers at risk are listed below the x-axis for both groups. The chart indicates hazard ratio (HR) of 0.88 (95% CI: 0.74, 1.05) comparing Dapagliflozin to Placebo.*

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Figure-9b (Figure 9b 01)

This is a Kaplan-Meier curve plot showing the percentage of patients with events over 36 months from randomization for Dapagliflozin versus placebo. The y-axis represents patients with events (%) and the x-axis shows months from randomization. The plot includes numbers of patients at risk at various time points for both treatment and placebo groups. A hazard ratio with 95% confidence interval comparing Dapagliflozin to placebo is displayed.*

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Figure_2 (Image 01)

A line graph showing adjusted mean percentage change from baseline HbA1c over 24 study weeks for three treatment groups: Dapagliflozin 10 mg plus Metformin, Dapagliflozin 10 mg alone, and Metformin alone. The graph includes data points at weeks 0, 4, 8, 12, 16, 20, and 24 with a lower HbA1c change observed in the combination group compared to monotherapies. A side graph depicts Week 24 data with 95% confidence intervals, showing comparative effectiveness among the groups.*

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Figure_3 (Image 02)

A line graph depicting adjusted mean change from baseline in HbA1c (%) over 24 study weeks comparing Dapagliflozin 10 mg plus Metformin versus Placebo plus Metformin. The x-axis shows study weeks (0 to 24), and the y-axis shows HbA1c (%) adjusted mean change from baseline. Two lines represent the treatment groups with Dapagliflozin showing a larger reduction in HbA1c over time. The graph includes error bars and a legend identifying each group.*

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Figure_6 (Image 03)

A line graph comparing the percentage of patients with an event over 32 months from randomization for Dapagliflozin versus Placebo. The graph shows fewer patients with events in the Dapagliflozin group compared to Placebo. It includes a hazard ratio (HR) of 0.61 with 95% confidence interval (0.51, 0.72) and a P-value of less than 0.0001. The number of patients at risk is shown below the timeline for both groups.*

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Figure_7a (Image 04)

A line graph comparing the percentage of patients with event over months from randomization between dapagliflozin and placebo groups. The graph includes patient numbers at risk at various time points and reports a hazard ratio of 0.74 (95% CI: 0.65-0.85) with a P-value less than 0.0001 for dapagliflozin versus placebo.*

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Figure-7b (Image 05)

A Kaplan-Meier cumulative event curve comparing the percentage of patients experiencing an event over 36 months from randomization between Dapagliflozin and Placebo groups. The graph shows two lines: a solid line for Dapagliflozin and a dashed line for Placebo, with a lower event rate in the Dapagliflozin group. Below the graph, the number of patients at risk is listed at multiple time points for both groups. The hazard ratio (HR) with 95% confidence interval and p-value for Dapagliflozin versus Placebo are also displayed.*

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Figure-8a (Image 06)

A Kaplan-Meier curve comparing the percentage of patients with events over months from randomization for Dapagliflozin versus placebo. The chart shows cumulative events for each group with a hazard ratio (HR) of 0.82 (95% CI: 0.69, 0.98) and a P-value of 0.0294. Patient counts at risk are displayed below the X-axis at several time points.*

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Figure-9a (Image 07)

A Kaplan-Meier survival curve comparing the percentage of patients with events over months from randomization between Dapagliflozin and placebo groups. The graph shows two lines: a solid line for Dapagliflozin and a dashed line for placebo, with event rates lower in the Dapagliflozin group. Patient numbers at risk for each group are listed below the x-axis. A hazard ratio (HR) of 0.70 with 95% confidence interval (0.59, 0.83) is displayed comparing Dapagliflozin to placebo.*

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Label Image (Lbl500907057)

DAPAGLIFLOZIN 10 mg film-coated tablets packaging label from A-S Medication Solutions. The label includes the lot number, storage instructions to keep between 68 to 77 degrees Fahrenheit, quantity of 30 tablets, and directions to see the package insert for dosing. It notes each tablet contains 10 mg dapagliflozin equivalent as dapagliflozin propanediol.*

* 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.