Dapagliflozin And Metformin Hydrochloride Tablet, Film Coated, Extended Release
Product Images NDC 67877-620

Product Visual Gallery

This gallery contains 15 technical images submitted to the FDA as part of the official labeling for Dapagliflozin And Metformin Hydrochloride (NDC 67877-620). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Ascend Laboratories, Llc, 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-30tab-a (Dapagliflozin 30tab A)

Label for Dapagliflozin and Metformin HCl Extended-Release Tablets containing 5 mg dapagliflozin and 500 mg metformin hydrochloride per tablet. The label states a package count of 30 tablets, includes storage instructions, manufacturer (Alkem Laboratories, India), distributor Ascend Laboratories, LLC, and features a barcode. The label advises dispensing the enclosed Medication Guide with each patient and specifies tablets are Rx only.*

FDA Label Image

Dapagliflozin-500tab-a (Dapagliflozin 500tab A)

Label for Dapagliflozin and Metformin HCl Extended-Release Tablets, containing 10 mg dapagliflozin and 500 mg metformin hydrochloride per tablet. The label shows the dosage form as tablets with a 500 count package size. It includes storage instructions, manufacturer and distributor details (Alkem Laboratories Ltd. and Ascend Laboratories, LLC), and cautions such as not crushing or chewing the tablets. The product is Rx Only.*

FDA Label Image

Dapagliflozin-60tab-a (Dapagliflozin 60tab A)

Label for Dapagliflozin and Metformin HCl Extended-Release Tablets, 5 mg/1000 mg strength. The label indicates a quantity of 60 tablets. It includes storage instructions, manufacturer info (Alkem Laboratories Ltd., India), and distributor Ascend Laboratories, LLC. The label also advises dispensing the enclosed Medication Guide and states tablets must be swallowed whole.*

FDA Label Image

Dapagliflozin-cart-100tab-a (Dapagliflozin Cart 100tab A)

Packaging label for dapagliflozin and metformin hydrochloride extended-release tablets, strength 10 mg/1000 mg. The label displays the tablet count of 100 tablets (10X10 unit-dose) and instructions to dispense the Medication Guide to each patient. Manufactured by Alkem Laboratories Ltd. and distributed by Ascend Laboratories, LLC.*

FDA Label Image

Dapagliflozin-fig-1 (Dapagliflozin Fig 1)

A scatter plot and fitted lines showing the relationship between dapagliflozin dose (mg) on a logarithmic scale and change from baseline (CFB) in 24-hour urinary glucose (g). Observed values are plotted for healthy subjects (open circles) and subjects with type 2 diabetes mellitus (T2DM, asterisks). Fitted lines illustrate the dose-response trend for each group, with a solid line for T2DM subjects and a dashed line for healthy subjects.*

FDA Label Image

Dapagliflozin-fig-2.jpg (Dapagliflozin Fig 2)

A line graph showing the adjusted mean change from baseline in HbA1c (%) over 24 weeks for dapagliflozin 10 mg plus metformin extended release (XR), dapagliflozin 10 mg alone, and metformin XR alone. The x-axis represents study weeks, and the y-axis measures HbA1c change. The graph includes a legend identifying three treatment groups and a section on the right depicting Week 24 last observation carried forward (LOCF) data with confidence intervals.*

FDA Label Image

Dapagliflozin-fig-3.jpg (Dapagliflozin Fig 3)

A line graph depicting adjusted mean change from baseline in HbA1c (%) over 24 study weeks for two groups: placebo plus metformin and dapagliflozin 10 mg plus metformin. The x-axis represents study weeks; the y-axis shows HbA1c change. The dapagliflozin group shows a greater reduction in HbA1c compared to placebo. Error bars and model details are noted below the graph.*

FDA Label Image

Dapagliflozin-figure 4 (Dapagliflozin Figure 4)

A line graph comparing the percentage of patients with events over 60 months from randomization between placebo and dapagliflozin groups. The x-axis represents months from randomization, and the y-axis shows the percentage of patients with events. Data points indicate fewer events in the dapagliflozin group compared to placebo over time, with a table showing patients at risk at various time points for both groups.*

FDA Label Image

Dapagliflozin-figure 5 (Dapagliflozin Figure 5)

A line graph comparing patients with events over 60 months from randomization between dapagliflozin and placebo groups. The y-axis represents the percentage of patients with events, while the x-axis shows months from randomization. The dapagliflozin group shows a lower percentage of patients with events than the placebo group over time. Below the graph, numbers of patients at risk at different months are listed for both groups.*

FDA Label Image

Dapagliflozin-figure-6 (Dapagliflozin Figure 6)

A line graph comparing the percentage of patients with an event over 32 months from randomization for dapagliflozin versus placebo. The y-axis shows the percentage of patients with events, and the x-axis shows months from randomization. The graph includes data on patients at risk at various time points for both groups and a hazard ratio with confidence intervals for dapagliflozin versus placebo.*

FDA Label Image

Dapagliflozin-figure-7a (Dapagliflozin Figure 7a)

A Kaplan-Meier curve showing the percentage of patients with an event over 36 months from randomization, comparing dapagliflozin to placebo. The graph indicates fewer patients with events on dapagliflozin over time. Patient numbers at risk are listed below the x-axis for both groups.*

FDA Label Image

Dapagliflozin-figure-7b (Dapagliflozin Figure 7b)

A line graph depicting the percentage of patients with an event over time (months from randomization) comparing dapagliflozin and placebo groups. The graph shows a lower event rate over approximately 36 months for the dapagliflozin group versus the placebo group. Patient risk numbers are listed below the x-axis for each time point. Statistical data including hazard ratio, confidence interval, and p-value are provided.*

FDA Label Image

Dapagliflozin-figure-8 (Dapagliflozin Figure 8)

A forest plot chart depicting hazard ratios (HR) with 95% confidence intervals (CI) comparing dapagliflozin versus placebo across different left ventricular ejection fraction (LVEF) categories from two studies, DAPA-HF and DELIVER. The chart includes numerical data of events over total participants for dapagliflozin and placebo groups, with a horizontal axis ranging from 0.5 to 2 representing the relative effect, indicating whether dapagliflozin or placebo is better.*

FDA Label Image

Dapagliflozin-metformin-a (Dapagliflozin Metformin A)

Chemical structure of metformin hydrochloride, showing the arrangement of nitrogen, carbon, hydrogen atoms, and associated hydrochloride group (HCl).*

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Dapagliflozin-structure-a (Dapagliflozin Structure A)

Chemical structure diagram of the active ingredient dapagliflozin, showing its molecular framework including hydroxyl groups, a chlorine atom, and an ethoxy substituent on aromatic rings.*

* 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.