Dapagliflozin Tablet, Film Coated
Product Images NDC 70377-023

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Dapagliflozin (NDC 70377-023). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Biocon Pharma 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

Dapagliflozin-10-mg-30s-syn (Dapagliflozin 10mg 30s Syn)

Label for Dapagliflozin Tablets 10 mg film-coated tablets from Biocon Pharma Inc., containing 30 tablets. The label includes storage instructions, manufacturing details (Syngene International Limited, India), and a barcode. It warns not to use if the printed inner seal is broken or missing and advises dispensing the accompanying medication guide to each patient.*

FDA Label Image

10mg 30count (Dapagliflozin 10mg 30s)

Label for Dapagliflozin Tablets 10 mg, film-coated oral tablets. The label shows 30 tablets per container, with the dosage strength prominently displayed in a green box. Manufactured and labeled by Biocon Pharma Inc. and Biocon Pharma Limited, with addresses in New Jersey, USA, and Bengaluru, India. The label includes storage instructions, dispensing advice, and a barcode along with serialization coding area.*

FDA Label Image

Dapagliflozin-5-mg-30s-syn (Dapagliflozin 5mg 30s Syn)

Label for Dapagliflozin Tablets 5 mg film-coated tablets in a 30-count bottle. Manufactured for Biocon Pharma Inc., Iselin, NJ, and by Syngene International Limited, India. The label states the product is Rx Only, with storage instructions and warnings about the bottle seal and child safety. Includes a barcode and serialization area.*

FDA Label Image

5mg 30count (Dapagliflozin 5mg 30s)

Label for Dapagliflozin Tablets 5 mg film-coated oral tablets by Biocon Pharma Inc. The package contains 30 tablets and includes a barcode. The label instructs dispensing the accompanying Medication Guide with each patient and notes the product is manufactured in India. Storage instructions and warnings about the integrity of the inner seal are also included.*

FDA Label Image

Dapagliflozin Figure 1 (Dapagliflozin Fig1)

A scatter plot graph depicting the concentration-effect relationship of dapagliflozin dose (mg) on the change from baseline in 24-hour urinary glucose (g). The graph shows observed values for healthy subjects and subjects with type 2 diabetes mellitus (T2DM) as plotted points, along with fitted lines for both groups illustrating the dose-response trend.*

FDA Label Image

Dapagliflozin Chemical Structure (Dapagliflozin Struct)

Chemical structure of dapagliflozin, shown with its glucose moiety and additional substituents, including a chlorine atom and ethoxy group, along with a hydrate component (H2O).*

FDA Label Image

Fig2 (Fig2)

A line graph depicting adjusted mean change from baseline in HbA1c (%) over 24 weeks of study. The x-axis shows study weeks from 0 to 24, and the y-axis shows HbA1c (%) change from baseline. Three groups are plotted: DAPAGLIFLOZIN 10 mg + METFORMIN, DAPAGLIFLOZIN 10 mg alone, and METFORMIN alone. The graph shows decreasing HbA1c values over time for all groups, with DAPAGLIFLOZIN 10 mg + METFORMIN demonstrating the greatest reduction. A separate side plot for week 24 (LOCF) presents adjusted mean changes with 95% confidence intervals for each group.*

FDA Label Image

Fig3 (Fig3)

A line graph showing HbA1c (%) adjusted mean change from baseline over 24 weeks comparing Placebo + Metformin versus Dapagliflozin 10 mg + Metformin. The graph includes data points and error bars for each treatment group, indicating a greater reduction in HbA1c with Dapagliflozin 10 mg + Metformin compared to Placebo + Metformin over time.*

FDA Label Image

Figure4 (Fig4)

A line graph comparing the percentage of patients with an event over time in months from randomization between two groups: Dapagliflozin and Placebo. The y-axis shows patients with event (%) and the x-axis shows months from randomization up to 60 months. The graph includes a table of patients at risk for both groups at various time points.*

FDA Label Image

Figure5 (Fig5)

A line graph comparing the percentage of patients with an event over time between dapagliflozin and placebo groups. The x-axis shows months from randomization (0 to 60), and the y-axis shows percentage of patients with event (0.0% to 4.5%). The dapagliflozin group has a lower percentage curve than the placebo group. A table below the graph lists patients at risk at various time points for both groups.*

* 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.