Dapagliflozin Tablet, Film Coated
Product Images NDC 63629-3253

Product Visual Gallery

This gallery contains 17 technical images submitted to the FDA as part of the official labeling for Dapagliflozin (NDC 63629-3253). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Bryant Ranch Prepack, 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

Figure_4 (Figure 4)

A Kaplan-Meier curve displaying the percentage of patients with events over 60 months from randomization, comparing Dapagliflozin and Placebo groups. The y-axis represents the percentage of patients with events, and the x-axis shows months from randomization. The chart includes patient risk numbers at various time points for both groups.*

FDA Label Image

Figure_5 (Figure 5)

A cumulative incidence line graph showing the percentage of patients with an event over 60 months from randomization, comparing Dapagliflozin and placebo. The x-axis represents time in months, and the y-axis shows the percentage of patients with events. Patient counts at risk for both groups are listed below the graph at various time points.*

FDA Label Image

Dapagliflozin Chemical Structure (Dapagliflozin Struct)

Chemical structure of dapagliflozin, showing the molecular arrangement including sugar moiety, aromatic rings with chlorine and ethoxy substituents, and hydration components.*

FDA Label Image

Figure_1 (Farxiga Fig1)

This is a dose-response scatter plot showing the relationship between dapagliflozin dose (mg) on a logarithmic scale and change in 24-hour urinary glucose excretion (g). The plot displays observed values for healthy subjects and subjects with type 2 diabetes mellitus (T2DM) distinguished by different markers. Solid and dashed lines represent fitted dose-response curves for T2DM and healthy subjects, respectively.*

FDA Label Image

Figure_10a (Figure 10a)

A forest plot comparing hazard ratios (HR) with 95% confidence intervals (CI) for various subgroups between Dapagliflozin and placebo. The chart includes characteristics like age, sex, race, geographic region, NYHA class, NT-proBNP levels, hospitalization history, MRA use, diabetes status, atrial fibrillation, heart failure etiology, BMI, and baseline eGFR. The plot visually shows relative effectiveness of Dapagliflozin versus placebo for each subgroup.*

FDA Label Image

Figure_10b (Figure 10b)

A forest plot chart showing hazard ratios (HR) with 95% confidence intervals (CI) comparing Dapagliflozin and placebo across various demographic and clinical subgroups. The subgroups include age, sex, race, geographic region, NYHA class, NT-proBNP levels, subacute status, T2DM at enrollment, atrial fibrillation/flutter, BMI, baseline eGFR, and SBP at randomization. The plot visually represents subgroup effects on the composite primary endpoint.*

FDA Label Image

Figure_11 (Figure 11 01)

A forest plot chart illustrating hazard ratios (HR) with 95% confidence intervals comparing dapagliflozin versus placebo across different left ventricular ejection fraction (LVEF) categories in the DAPA-HF and DELIVER studies. The plot shows HR values favoring dapagliflozin over placebo with specific numeric comparisons of event counts and total subjects for each LVEF category.*

FDA Label Image

Figure_8b (Figure 8b)

A line graph depicting the percentage of patients with an event over 36 months from randomization, comparing Dapagliflozin and Placebo groups. The graph shows two lines: a solid line for Dapagliflozin and a dashed line for Placebo, with the Placebo line generally higher. Patient counts at risk are listed below the x-axis for each time point. A hazard ratio (HR) with 95% confidence interval is provided, comparing Dapagliflozin to Placebo.*

FDA Label Image

Figure-9b (Figure 9b 01)

A Kaplan-Meier curve chart comparing the percentage of patients with an event over 36 months from randomization between Dapagliflozin and placebo groups. The chart shows the number of patients at risk below the x-axis at various time points. The hazard ratio (HR) with 95% confidence interval for Dapagliflozin versus placebo is provided in the chart area.*

FDA Label Image

Figure_2 (Image 01)

A line graph showing adjusted mean change from baseline in HbA1c (%) over 24 weeks in a study comparing Dapagliflozin 10 mg plus Metformin, Dapagliflozin 10 mg alone, and Metformin alone. The x-axis represents study weeks from 0 to 24, and the y-axis depicts percent change in HbA1c with values decreasing below zero. The graph includes a legend identifying treatment groups by symbol and type of lines.*

FDA Label Image

Figure_3 (Image 02)

A line graph showing adjusted mean change from baseline in HbA1c (%) over 24 weeks of study. Two groups are compared: Placebo plus Metformin and Dapagliflozin 10 mg plus Metformin. The Dapagliflozin group shows a larger decrease in HbA1c levels compared to the placebo group throughout the study. Error bars for Week 24 adjusted mean changes with 95% confidence intervals are shown on the right side.*

FDA Label Image

Figure_6 (Image 03)

A Kaplan-Meier curve comparing the percentage of patients experiencing an event over 32 months from randomization between Dapagliflozin and placebo groups. The graph shows fewer patients with events in the Dapagliflozin group compared to placebo, with hazard ratio 0.61 (95% CI: 0.51 to 0.72) and a p-value less than 0.0001. The number of patients at risk is shown below the time axis for both groups.*

FDA Label Image

Figure_7a (Image 04)

A Kaplan-Meier curve comparing the percentage of patients with events over months from randomization between Dapagliflozin and Placebo groups. The chart shows patients at risk at multiple time points. Hazard ratio (HR) with 95% confidence interval and p-value for Dapagliflozin versus Placebo are also included.*

FDA Label Image

Figure-7b (Image 05)

A Kaplan-Meier curve comparing the percentage of patients experiencing an event over 36 months between dapagliflozin and placebo groups. The x-axis shows months from randomization, and the y-axis shows patients with event (%). The plot includes hazard ratio with confidence interval and p-value for dapagliflozin vs. placebo. Numbers of patients at risk at various time points are listed below the graph for both groups.*

FDA Label Image

Figure-8a (Image 06)

A Kaplan-Meier curve graph depicting the percentage of patients with events over a 36-month period, comparing Dapagliflozin and Placebo groups. The graph shows time in months on the x-axis and patients with event (%) on the y-axis, including a hazard ratio and p-value for Dapagliflozin vs. Placebo. A table of patients at risk at various months accompanies the graph.*

FDA Label Image

Figure-9a (Image 07)

A Kaplan-Meier curve comparing the percentage of patients with an event over 36 months from randomization for Dapagliflozin versus Placebo. The chart plots patients with events (%) on the y-axis and months from randomization on the x-axis, showing lower events over time for Dapagliflozin. Patient risk counts at various time points are shown below the graph.*

FDA Label Image

Label (Lbl636293253)

Dapagliflozin Tablets 10 mg film-coated tablets, bottle label with a quantity of 30 tablets. The label includes the NDC 63629-3253-1 and indicates the product is repackaged by Bryant Ranch Prepack, Inc. and manufactured by AstraZeneca AB. It provides storage instructions, safety warnings, and a barcode.*

* 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.