Dapagliflozin Tablet, Film Coated
Product Images NDC 0480-3527

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Dapagliflozin (NDC 0480-3527). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Teva Pharmaceuticals, Inc., 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

1 (Image 1)

Chemical structure of dapagliflozin showing its molecular arrangement, including aromatic rings, hydroxyl groups, a chlorine atom, and an ethoxy group.*

FDA Label Image

1 (Image 2)

A scatter plot with dose-response curves showing cumulative excretion rate (CER) in 24-hour urinary glucose (g) versus dapagliflozin dose (mg) on a logarithmic scale. Observed data points for healthy subjects and subjects with type 2 diabetes mellitus (T2DM) are depicted, along with fitted lines for each group illustrating the relationship between dapagliflozin dose and urinary glucose excretion.*

FDA Label Image

2 (Image 3)

A line graph showing the 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 (0 to 24), and the y-axis shows the percentage change in HbA1c. Three lines with distinct markers indicate each treatment group's trend, with an additional plot on the right showing Week 24 data with last observation carried forward (LOCF) and 95% confidence intervals.*

FDA Label Image

3 (Image 4)

A line graph comparing the percentage adjusted mean change from baseline in HbA1c levels over 24 weeks between two groups: 'Placebo + Metformin' and 'Dapagliflozin 10 mg + Metformin.' The graph shows data points and error bars, with the dapagliflozin group exhibiting a larger reduction in HbA1c. Additional notes below the graph explain the data modeling and statistical analysis methods.*

FDA Label Image

4 (Image 5)

A line graph comparing the percentage of patients with events over months from randomization between Dapagliflozin and Placebo groups. The x-axis represents time in months up to 60, and the y-axis shows patients with event percentage up to 7%. Both groups start near 0%, with the Placebo group showing a generally higher event rate over time. A table below details the number of patients at risk at various time points for both groups.*

FDA Label Image

5 (Image 6)

A Kaplan-Meier curve showing the percentage of patients with an event over time in months from randomization. The graph compares Dapagliflozin versus placebo groups, with patient numbers at risk listed below the x-axis. The curve for Dapagliflozin shows lower event percentages compared to placebo throughout the study period up to 60 months.*

FDA Label Image

Label, 5 mg, 30s (Image 7)

Label for Dapagliflozin Tablets 5 mg film-coated tablets by Teva Pharmaceuticals, Inc. The label includes dosage instructions referencing the package insert, storage conditions, and dispensing guidance. The quantity stated is 30 tablets. The label also notes the product is Rx only and includes manufacturer details from Watson Pharma Private Limited, India.*

FDA Label Image

Label, 10 mg, 30s (Image 8)

Label for Dapagliflozin Tablets 10 mg film-coated tablets from Teva Pharmaceuticals, Inc. The package contains 30 tablets for oral use. The label includes storage instructions, dispensing information, and manufacturer details, with a barcode and space for lot/expiration/serialization coding.*

* 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.