Dapagliflozin Tablet, Film Coated
Product Images NDC 59651-159

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Dapagliflozin (NDC 59651-159). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aurobindo Pharma Limited, 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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Chemical Structure (Dapagliflozin Str)

Chemical structure of dapagliflozin, showing its molecular components including hydroxyl groups, a chlorine atom, and a methoxyphenyl group.*

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Figure 1: Scatter Plot And Fitted Line Of Change From Baseline In 24-hour Urinary Glucose Amount Versus Dapagliflozin Dose In Healthy Subjects And Subjects With Type 2 Diabetes Mellitus (t2dm) (semi-log Plot) (Dapagliflozin Fig1)

A scatter plot graph displaying the relationship between dapagliflozin dose (mg, logarithmic scale) on the x-axis and cumulative 24-hour urinary glucose excretion (g) on the y-axis. It includes observed values for healthy subjects and subjects with type 2 diabetes mellitus (T2DM) along with fitted response lines for each group, illustrating dose-dependent glucose excretion.*

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Figure 2: Adjusted Mean Change From Baseline Over Time In Hba1c (%) In A 24-week Active-controlled Study Of Dapagliflozin Initial Combination Therapy With Metformin Xr (Dapagliflozin Fig2)

A line graph depicting adjusted mean change in HbA1c (%) from baseline over 24 study weeks for dapagliflozin 10 mg plus metformin, dapagliflozin 10 mg alone, and metformin alone. The graph shows a decrease in HbA1c for all groups, with the dapagliflozin plus metformin group showing the greatest reduction. A separate bar graph on the right shows adjusted mean change at week 24 using last observation carried forward (LOCF) analysis.*

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Figure 3 (Dapagliflozin Fig3)

A line graph showing the change in HbA1c percentage from baseline over 24 weeks in study groups treated with Placebo plus Metformin and Dapagliflozin 10 mg plus Metformin. The graph includes mean change values with error bars, comparing efficacy between the two groups across the study period.*

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Figure (Dapagliflozin Fig4)

A line graph comparing the percentage of patients with an event over months from randomization between Dapagliflozin and placebo. The x-axis represents months from randomization (0 to 60), and the y-axis represents the percentage of patients with an event (0% to 7%). The graph shows two lines: one for Dapagliflozin and one for placebo, with placebo consistently higher. A table below the graph lists patient numbers at risk for both groups at various months.*

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Figure (Dapagliflozin Fig5)

A Kaplan-Meier curve chart depicting the percentage of patients with event over time in months from randomization, comparing Dapagliflozin and placebo groups. The chart shows the cumulative event rates for both groups with Dapagliflozin having a lower percentage, and includes a table below with the number of patients at risk at various time points up to 60 months.*

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Package Label-principal Display Panel (5 mg)

Label for Dapagliflozin Tablets 5 mg film-coated oral tablets. The label states a package count of 30 tablets and includes storage instructions, pharmacist cautions, and distributor information from Aurobindo Pharma USA, Inc. A barcode and coding area for lot and expiry data are visible. The label specifies the product is made in India by Aurobindo Pharma Limited.*

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Package Label-principal Display Panel (10 mg)

Dapagliflozin Tablets 10 mg film-coated tablets label showing a bottle with 30 tablets. The label includes storage instructions, distributor Aurobindo Pharma USA, Inc., and a barcode. It emphasizes dispensing a medication guide and notes that the product is made in India by Aurobindo Pharma Limited.*

* 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.