Dapagliflozin And Metformin Hydrochloride Tablet, Film Coated, Extended Release
Product Images NDC 63304-027

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Dapagliflozin And Metformin Hydrochloride (NDC 63304-027). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Sun Pharmaceutical Industries, 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

Dapamet Label-10mg1000mg (Dapamet Label 10mg1000mg)

Label for Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets with strength 10 mg/1000 mg. The oral film-coated extended-release tablets come in a container of 30 tablets. Manufactured by Ohm Laboratories Inc. and distributed by Sun Pharmaceutical Industries, Inc. The label includes usage instructions to swallow whole and to dispense a medication guide to patients, along with storage and safety information.*

FDA Label Image

Dapamet Label-10mg500mg (Dapamet Label 10mg500mg)

Label for Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets, 10 mg/500 mg, oral film-coated tablet. The label states 30 tablets per bottle, distributed by Sun Pharmaceutical Industries, Inc. It includes storage instructions, barcodes, and a notice for pharmacists to dispense a Medication Guide. The label advises not to crush, cut, or chew tablets, which must be swallowed whole.*

FDA Label Image

Dapamet Label-5mg1000mg (Dapamet Label 5mg1000mg)

Label for Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets, 5 mg/1000 mg strength. The label includes NDC 63304-026-62 and states the dosage form as film-coated extended-release tablets. It features warnings about not crushing, cutting, or chewing tablets, prescription-only status, quantity of 60 tablets, and is labeled by Sun Pharmaceutical Industries, Inc. The design includes a barcode and a note for pharmacists to dispense the accompanying Medication Guide.*

FDA Label Image

Dapagliflozin Structural Formula (Dapagliflozin Structural Formula)

Chemical structure of dapagliflozin, an active ingredient in Dapagliflozin and Metformin Hydrochloride extended-release tablets by Sun Pharmaceutical Industries, Inc.*

FDA Label Image

Figure 1 (Figure 1)

A scatter plot and fitted lines graph showing change from baseline in 24-hour urinary glucose (g) versus dapagliflozin dose (mg) on a logarithmic scale. The graph includes observed values for healthy subjects and subjects with type 2 diabetes mellitus (T2DM), with corresponding fitted lines for each group illustrating the relationship between dapagliflozin dose and urinary glucose excretion.*

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Figure 2 (Figure 2)

A line graph showing HbA1c (%) adjusted mean change from baseline over 24 study weeks for three treatments: Dapagliflozin 10 mg plus Metformin XR, Dapagliflozin 10 mg, and Metformin XR alone. The y-axis indicates percent change in HbA1c, and the x-axis represents study weeks. A right-side panel shows 24-week adjusted mean change and 95% confidence intervals for each treatment.*

FDA Label Image

Figure 4 (Figure 4)

A Kaplan-Meier cumulative incidence plot showing the percentage of patients with an event over time in months from randomization, comparing Dapagliflozin treatment versus placebo. The graph includes the number of patients at risk at various time points for both groups, with Dapagliflozin showing a lower incidence of events compared to placebo over approximately 60 months.*

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Figure 5 (Figure 5)

A Kaplan-Meier-type plot showing the percentage of patients with event over time in months from randomization. Two lines compare event rates for patients on Dapagliflozin and Placebo. The plot shows patient risk numbers across months for both groups, with Placebo line trending higher than Dapagliflozin, indicating a higher percentage of patients with an event over the study duration.*

FDA Label Image

Figure 6 (Figure 6)

A line graph comparing the percentage of patients with an event over time in months from randomization for Dapagliflozin versus Placebo. The y-axis represents the percentage of patients with the event, and the x-axis shows months from 0 to 32. The graph includes a table below showing the number of patients at risk for each group at various time points. Dapagliflozin shows a lower event rate compared to Placebo over time.*

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Figure 7a (Figure 7a)

A Kaplan-Meier curve depicting the percentage of patients with an event over time in months from randomization, comparing Dapagliflozin and Placebo groups. The graph shows a lower event rate in the Dapagliflozin group over approximately 30 months. Below the x-axis, the number of patients at risk for each group at specified time points is listed.*

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Figure 7b (Figure 7b)

A line graph depicting the percentage of patients with an event over 36 months from randomization, comparing Dapagliflozin versus placebo. The y-axis represents the percent of patients with an event, and the x-axis shows months from randomization. The graph shows two lines: one solid line for Dapagliflozin and one dashed line for placebo, with placebo consistently higher. Below the graph is a table indicating the number of patients at risk at various months for both groups.*

FDA Label Image

Figure 8 (Figure 8)

A forest plot chart comparing hazard ratios (HR) with 95% confidence intervals (CI) for different left ventricular ejection fraction (LVEF) percentage categories across two studies, DAPA-HF and DELIVER. The chart contrasts dapagliflozin versus placebo, with numerical data showing events and sample sizes per group and HR values indicating relative effect sizes.*

FDA Label Image

Metformin HCl Structural Formula (Metformin HCl Structural Formula)

Chemical structure diagram of Metformin Hydrochloride, showing its molecular composition with nitrogen, carbon, hydrogen, and hydrochloride components.*

* 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.