Dapagliflozin Tablet, Film Coated
Product Images NDC 66993-457

Product Visual Gallery

This gallery contains 18 technical images submitted to the FDA as part of the official labeling for Dapagliflozin (NDC 66993-457). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Prasco Laboratories, 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 line chart comparing the percentage of patients with events over time between Dapagliflozin and placebo groups, spanning 0 to 60 months from randomization. The y-axis shows the percentage of patients with events, and the x-axis indicates months. The chart includes patient risk numbers at various intervals for both groups below the x-axis.*

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Figure_5 (Figure 5)

A line chart comparing the percentage of patients with an event over months from randomization for Dapagliflozin versus Placebo. The x-axis represents months up to 60, and the y-axis shows the percentage of patients with events up to 4.5%. Dapagliflozin shows a lower event rate compared to Placebo throughout the timeline. Below the graph, a table lists the number of patients at risk over time for both groups.*

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Dapagliflozin Chemical Structure (Dapagliflozin Struct)

Chemical structure of dapagliflozin showing its detailed molecular configuration including sugar and aromatic rings, a chlorine atom, and associated groups, along with an ethanol and water hydrate component.*

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Dapagliflozin 10mg Bottle Label (Farxiga 10mg 30s)

Dapagliflozin Tablets 10 mg film-coated oral tablets label manufactured by Prasco Laboratories. The label states package size of 30 tablets with NDC 66993-457-30 and includes storage instructions, dispensing instructions to provide a medication guide, and product identification with barcode and lot, expiration, and serial number fields.*

FDA Label Image

Dapagliflozin 5mg Bottle Label (Farxiga 5mg 30s)

Label for Dapagliflozin Tablets 5 mg film-coated tablets by Prasco Laboratories. The label indicates a package count of 30 tablets, includes storage instructions, warnings about the integrity of the seal, and directs to dispense with a medication guide. The NDC number is 66993-456-30.*

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Figure_1 (Farxiga Fig1)

A dose-response plot showing dapagliflozin dose (mg) on the x-axis and cumulative excretion of dapagliflozin in 24-hour urinary glucose (g) on the y-axis. The graph includes observed values and fitted lines for both healthy subjects and subjects with type 2 diabetes mellitus (T2DM), indicating different urinary glucose excretion patterns between the groups.*

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Figure_10a (Figure 10a)

A forest plot chart comparing hazard ratios (HR) with 95% confidence intervals (CI) for various patient characteristics between Dapagliflozin and placebo groups. It includes subgroups by 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, showing relative outcomes of Dapagliflozin versus placebo.*

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Figure_10b (Figure 10b)

A forest plot showing hazard ratios (HR) with 95% confidence intervals comparing dapagliflozin versus placebo across various subgroups including age, sex, race, geographic region, NYHA class, NT-proBNP levels, subacute status, T2DM enrollment, atrial fibrillation, BMI, baseline eGFR, and systolic blood pressure. The plot visually represents treatment effect consistency with HR values and sample sizes listed for each subgroup.*

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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 and studies (DAPA-HF and DELIVER). The plot visually indicates treatment effect favoring Dapagliflozin in all categories, with numeric values for patient counts and HRs shown in tabular form beside the graph.*

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Figure_8b (Figure 8b)

A line graph 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 the percentage of patients with events. The graph includes a hazard ratio (HR) of 0.88 with 95% confidence interval (0.74, 1.05). A table below the graph lists patients at risk for each time point for both groups.*

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Figure-9b (Figure 9b 01)

A Kaplan-Meier plot showing the percentage of patients with an event over 36 months from randomization, comparing dapagliflozin tablets and placebo. The graph includes hazard ratio statistics and displays the number of patients at risk at multiple time points for both treatment groups.*

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Figure_2 (Image 01)

A line graph depicting the adjusted mean percentage change in HbA1c from baseline over 24 study weeks. It compares three groups: Dapagliflozin 10 mg with Metformin, Dapagliflozin 10 mg alone, and Metformin alone. The graph shows changes at multiple time points and includes a separate display of week 24 adjusted mean change with 95% confidence intervals (LOCF).*

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Figure_3 (Image 02)

A line graph showing HbA1c (%) adjusted mean change from baseline over 24 study weeks comparing placebo plus metformin and dapagliflozin 10 mg plus metformin. The x-axis represents study weeks, and the y-axis indicates percent change in HbA1c. Two lines depict treatment groups, with dapagliflozin plus metformin showing greater HbA1c reduction than placebo plus metformin. Error bars for week 24 last observation carried forward (LOCF) values are shown on the right.*

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Figure_6 (Image 03)

A survival curve line graph comparing the percentage of patients with events over 32 months from randomization between Dapagliflozin and placebo groups. The x-axis shows months from randomization, and the y-axis shows percentage of patients with events. The Dapagliflozin line is consistently lower than the placebo line, with hazard ratio and p-value indicated. A table below the graph shows the number of patients at risk over time in both groups.*

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Figure_7a (Image 04)

A Kaplan-Meier plot comparing the percentage of patients with an event over time (months from randomization) between Dapagliflozin and placebo groups. The graph shows a lower event rate for Dapagliflozin compared to placebo over approximately 27 months, with hazard ratio, confidence interval, and statistical significance data included. Patient numbers at risk for each group are displayed below the x-axis.*

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Figure-7b (Image 05)

A line chart comparing the percentage of patients with an event over 36 months from randomization for Dapagliflozin versus Placebo. The chart shows patients at risk over time and includes statistical data: hazard ratio (HR) 0.82 with 95% confidence interval (CI) 0.73 to 0.92 and a p-value of 0.0008, indicating the comparison results between Dapagliflozin and Placebo.*

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Figure-8a (Image 06)

A Kaplan-Meier survival curve chart comparing the percentage of patients with events over time (months from randomization) between Dapagliflozin and placebo groups. The chart shows patient risk numbers at various time points and includes hazard ratio (HR), confidence interval (CI), and p-value for comparison.*

FDA Label Image

Figure-9a (Image 07)

A Kaplan-Meier curve showing the percentage of patients with an event over months from randomization for Dapagliflozin versus placebo. The graph includes a survival curve with the number of patients at risk at several time points for both groups. Hazard ratio (HR) with 95% confidence interval (CI) comparing Dapagliflozin to placebo is also displayed.*

* 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.