Dapagliflozin Tablet, Film Coated
Product Images NDC 60505-4911

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Dapagliflozin (NDC 60505-4911). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Apotex Corp., 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 (Figure1)

A scatter plot showing the relationship between dapagliflozin dose (mg, logarithmic scale on the x-axis) and CFB in 24-hour urinary glucose (g) on the y-axis. The plot includes observed values for healthy subjects and subjects with T2DM, along with fitted lines for each group indicating glucose excretion response to increasing doses of dapagliflozin.*

FDA Label Image

Figure (Figure2)

A line graph depicting HbA1c (%) adjusted mean change from baseline over 24 study weeks for three groups: Dapagliflozin 10 mg combined with Metformin, Dapagliflozin 10 mg alone, and Metformin alone. The graph shows changes at intervals up to 24 weeks with a separate section displaying values at week 24 using last observation carried forward (LOCF) method, including 95% confidence intervals.*

FDA Label Image

Figure (Figure3)

A line graph showing adjusted mean percentage change from baseline in HbA1c levels over a 24-week study period. Two treatment groups are compared: Placebo + Metformin and Farxiga (Dapagliflozin) 10 mg + Metformin. The graph shows greater reduction in HbA1c with Farxiga plus Metformin than Placebo plus Metformin, including error bars at week 24 for last observation carried forward (LOCF).*

FDA Label Image

Figure (Figure4)

A line graph showing the percentage of patients with an event over time in months from randomization, comparing Dapagliflozin Tablet and Placebo groups. The graph includes a risk table below listing the number of patients at risk at various time points for both groups. The Placebo group shows a higher event rate over time compared to the Dapagliflozin Tablet group.*

FDA Label Image

Figure (Figure5)

A line graph comparing the percentage of patients with events over time between Dapagliflozin tablets and placebo. The x-axis represents months from randomization (0 to 60), and the y-axis shows the percentage of patients with events (0 to 4.5%). Two lines are displayed: a solid line for Dapagliflozin tablets with lower event rates, and a dotted line for placebo with higher event rates. Below the graph, a table lists the number of patients at risk for each group at multiple time points.*

FDA Label Image

Label (Image01)

Label for Dapagliflozin 5 mg film-coated tablets by Apotex Corp. The label states 30 tablets per package and includes storage instructions (20°C-25°C, excursions permitted to 15°C-30°C). It is marked Rx only and notes the package is child-resistant. Manufactured by Apotex Corp., Weston, Florida, USA. The label also contains a barcode and usage caution regarding broken or missing seals.*

FDA Label Image

Image Description (Image02)

Label for Dapagliflozin tablets 10 mg film-coated tablets, manufactured for Apotex Corp. The label includes dosing and storage instructions, a child-resistant package warning, and a bar code. The package contains 30 tablets for oral use.*

FDA Label Image

Structural (Structure)

Chemical structure of dapagliflozin showing a glucose-like ring attached to two aromatic rings, one with a chlorine substituent and the other with an ethoxy group.*

* 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.