Dapagliflozin Tablet, Film Coated
Product Images NDC 46708-393

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Dapagliflozin (NDC 46708-393). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Alembic Pharmaceuticals 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.

FDA Label Image

Figure 1 (Dapagliflozin 1 Figure)

A dose-response scatter plot showing the change from baseline (CFB) in 24-hour urinary glucose (g) versus dapagliflozin dose (mg) on a logarithmic scale. It includes observed values and fitted lines for both healthy subjects and subjects with type 2 diabetes mellitus (T2DM), comparing urinary glucose excretion at varying doses.*

FDA Label Image

30 Tablets (Dapagliflozin 10)

Dapagliflozin 10 mg film-coated tablets packaging label from Alembic Pharmaceuticals Limited. The label states the dosage strength as 10 mg per tablet, contains 30 tablets, and includes a note to dispense the accompanying Medication Guide to each patient. It also shows storage instructions, manufacturer details, and a barcode.*

FDA Label Image

Figure 4 (Dapagliflozin 4 Figure)

A Kaplan-Meier survival curve graph comparing the percentage of patients with events over 60 months between Dapagliflozin tablets and placebo groups. The x-axis shows months from randomization, and the y-axis shows the percentage of patients with events. A risk table below the graph lists the number of patients at risk at various months for each treatment group.*

FDA Label Image

Figure 5 (Dapagliflozin 5 Figure)

A line graph showing the percentage of patients with an event over 60 months from randomization, comparing Dapagliflozin Tablets and placebo groups. The graph plots patients with events (%) on the vertical axis and months from randomization on the horizontal axis, with the placebo group showing a higher event rate than the Dapagliflozin Tablets group. Below the graph is a table listing numbers of patients at risk at various time points for both groups.*

FDA Label Image

30 Tablets (Dapagliflozin 5)

Label for Dapagliflozin Tablets 5 mg by Alembic Pharmaceuticals Limited. The film-coated tablets are supplied in a 30-count package. The label includes dosage information, storage conditions, manufacturer details, barcode, lot, and expiration date fields.*

FDA Label Image

Figure 2 (Dapagliflozin Figure2)

A line graph showing adjusted mean percentage change from baseline in HbA1c levels over 24 weeks for three groups: Dapagliflozin tablets 10 mg with Metformin, Dapagliflozin tablets 10 mg alone, and Metformin alone. The graph illustrates HbA1c reduction across study weeks, with data points and confidence intervals at week 24 based on an ANCOVA model.*

FDA Label Image

Figure 3 (Dapagliflozin Figure3)

A line graph comparing adjusted mean percentage changes from baseline in HbA1c levels over 24 weeks between two groups: placebo plus metformin and dapagliflozin tablets 10 mg plus metformin. The graph includes data points at multiple study weeks with error bars representing variability, and a side bar graph showing Week 24 results with last observation carried forward (LOCF) along with 95% confidence intervals.*

FDA Label Image

Structure (Dapagliflozin Str)

Chemical structure of dapagliflozin, showing a glucose-derived moiety linked to a substituted aromatic ring system including chlorine and ether functional 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.