Dapagliflozin Tablet
Product Images NDC 42571-317

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Dapagliflozin (NDC 42571-317). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Micro Labs 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

Dapagliflozin-fig1.jpg (Dapagliflozin Fig1)

A dose-response plot showing 24-hour urinary glucose excretion versus dapagliflozin dose (mg) on a logarithmic x-axis. The graph includes observed values for healthy subjects and subjects with type 2 diabetes mellitus (T2DM), with fitted trend lines for both groups illustrating the relationship between dapagliflozin dose and urinary glucose excretion.*

FDA Label Image

Dapagliflozin-fig2.jpg (Dapagliflozin Fig2)

A line graph showing the adjusted mean change in HbA1c (%) from baseline over 24 weeks for three groups: Dapagliflozin 10 mg plus Metformin, Dapagliflozin 10 mg alone, and Metformin alone. The x-axis indicates study weeks (0 to 24), and the y-axis shows percent change in HbA1c from baseline. The right side includes a vertical plot of week 24 last observation carried forward (LOCF) values with confidence intervals for each group.*

FDA Label Image

Dapagliflozin-fig3.jpg (Dapagliflozin Fig3)

A longitudinal line graph comparing adjusted mean change from baseline in HbA1c percentage over 24 weeks between two treatment groups: Placebo plus Metformin and Dapagliflozin 10 mg plus Metformin. The graph shows a greater reduction in HbA1c with Dapagliflozin plus Metformin. Error bars indicate variability at Week 24 based on an ANCOVA model.*

FDA Label Image

Dapagliflozin-fig4.jpg (Dapagliflozin Fig4)

Line graph showing patients with events (%) over 60 months from randomization comparing Dapagliflozin and Placebo. The plot depicts percentage of patients with events increasing over time, with Dapagliflozin consistently lower than Placebo. Patient count at risk is provided at regular intervals for each group.*

FDA Label Image

Dapagliflozin-fig5.jpg (Dapagliflozin Fig5)

A Kaplan-Meier survival curve graph showing the percentage of patients with events over months from randomization, comparing Dapagliflozin and Placebo groups. The x-axis represents months from randomization up to 60, and the y-axis shows percentage of patients with event ranging from 0 to 4.5%. The graph includes a table below listing the number of patients at risk in each group at various time points.*

FDA Label Image

Dapagliflozin-structure.jpg (Dapagliflozin Structure)

Chemical structure diagram of dapagliflozin showing its molecular arrangement including hydroxyl groups, a chlorine atom, and ether linkages.*

FDA Label Image

Dapagliflozin10mglbl (Dapagliflozin10mglbl)

The label for Dapagliflozin Tablets 10 mg shows it as an oral prescription drug supplied in a package of 30 tablets. It is manufactured by Micro Labs Limited in India and marketed for Micro Labs USA Inc. Storage instructions note maintaining 20°C to 25°C with permitted excursions. The label includes a barcode and advises dispensing the enclosed Medication Guide to each patient.*

FDA Label Image

Dapagliflozin5mglbl (Dapagliflozin5mglbl)

Label for Dapagliflozin Tablets 5 mg, oral film-coated tablets. The label indicates a package of 30 tablets, manufactured by Micro Labs Limited and made for Micro Labs USA Inc., Somerset, NJ. It includes storage instructions and cautions about the integrity of the printed inner seal.*

* 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.