Dapagliflozin And Metformin Hydrochloride Tablet, Film Coated, Extended Release
Product Images NDC 66993-362

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Dapagliflozin And Metformin Hydrochloride (NDC 66993-362). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Prasco Laboratories, 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 4 (Figure 4)

A line graph showing the percentage of patients with an event over time in months from randomization, comparing dapagliflozin and placebo groups. The graph includes patient counts at risk over time for each group, illustrating incidence trends up to 60 months.*

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Figure 5 (Figure 5)

A line graph depicting the percentage of patients with an event over months from randomization, comparing dapagliflozin to placebo. The x-axis shows months from 0 to 60, and the y-axis shows the percentage of patients with event from 0 to 4.5%. The graph includes a risk table below indicating the number of patients at risk in both dapagliflozin and placebo groups over time.*

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Figure-6 (Figure 6)

A Kaplan-Meier curve chart showing the percentage of patients with an event over 24 months from randomization, comparing dapagliflozin with placebo. The y-axis represents patients with event (%) ranging from 0 to 30, and the x-axis represents months. The chart includes a hazard ratio (HR) with 95% confidence interval (CI) for dapagliflozin vs. placebo (0.74, 0.65-0.85) and lists the number of patients at risk for each group at various time points.*

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Figure-7 (Figure 7)

A Kaplan-Meier survival curve comparing the percentage of patients with an event over time (in months) from randomization between dapagliflozin and placebo groups. The y-axis shows patients with event percentage; the x-axis shows months from randomization up to 32 months. The graph includes the hazard ratio (HR 0.61, 95% CI 0.51 to 0.72) for dapagliflozin versus placebo. Patient numbers at risk over time are listed for both groups below the graph.*

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Dapagliflozin Chemical Structure (Image 01)

Chemical structure diagram showing the active ingredients dapagliflozin and metformin hydrochloride, including associated molecular fragments such as ethanol and water molecules.*

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Metformin Hydrochloride Chemical Structure (Image 02)

Chemical structure of dapagliflozin and metformin hydrochloride, showing the molecular formula with bonds and atoms including nitrogen (N), hydrogen (H), carbon (C), and chlorine (Cl) in hydrochloride form.*

FDA Label Image

Figure 1 (Image 03)

A scatter plot with fitted lines displaying dapagliflozin dose (mg) on the x-axis and change from baseline (CFB) in 24-hour urinary glucose (g) on the y-axis. It shows observed values and fitted dose-response lines for healthy subjects and subjects with type 2 diabetes mellitus (T2DM).*

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Figure 2 (Image 04)

Line graph showing adjusted mean change from baseline in HbA1c (%) over 24 study weeks. Three treatment groups are charted: dapagliflozin 10 mg plus metformin XR, dapagliflozin 10 mg alone, and metformin XR alone. The right side includes Week 24 last observation carried forward (LOCF) values with 95% confidence intervals based on an ANCOVA model.*

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Figure 3: Graph (Image 05)

A line graph showing the adjusted mean change in HbA1c percentage from baseline over 24 weeks comparing two groups: placebo plus metformin and dapagliflozin 10 mg plus metformin. The graph illustrates a greater reduction in HbA1c in the dapagliflozin plus metformin group throughout the study period. A side panel displays adjusted mean changes and 95% confidence intervals at Week 24 for both groups based on ANCOVA analysis.*

FDA Label Image

5mg_1000mg (Image 08)

Label for Prasco Laboratories dapagliflozin and metformin hydrochloride extended-release tablets, 5 mg/1000 mg strength. The label indicates 60 tablets in the package, oral route, with instructions to dispense with medication guide and warnings not to crush, cut, or chew tablets. Storage temperature and dosage information are also noted.*

FDA Label Image

10mg_1000mg (Image 10)

Label for Dapagliflozin and Metformin HCl Extended-Release Tablets 10 mg/1000 mg by Prasco Laboratories. The package contains 30 film-coated extended-release tablets for oral use. The label includes dosage form, strength, NDC 66993-362-30, and storage instructions. It advises dispensing with a medication guide and warns against crushing, cutting, or chewing tablets.*

* 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.