Dapagliflozin And Metformin Hydrochloride Tablet, Film Coated, Extended Release
Product Images NDC 84677-022

View Photos of Packaging, Regulatory Labels, and Product Appearance

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 84677-022). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Golden State Medical Supply, 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.

Product Images & Figures Index

FDA Label Image

84677-020-60ol- Dapa_met Tab 5_1000.jpg (84677 020 60ol Dapa Met Tab 5 1000)

84677-020-60ol- Dapa_met Tab 5_1000.jpg (84677 020 60ol Dapa Met Tab 5 1000)
Packaging label for Dapagliflozin and Metformin Hydrochloride extended-release tablets with a strength of 5 mg/1000 mg. The label includes dosage form as film-coated tablets, with a total of 60 tablets in the bottle. It is marketed by GSMS, Incorporated, and specifies handling instructions such as keeping out of reach of children and storage temperature. The label also includes a barcode and child-resistant packaging notice.*
FDA Label Image

84677-021-30ol- Dapa_met Tab 10_500.jpg (84677 021 30ol Dapa Met Tab 10 500)

84677-021-30ol- Dapa_met Tab 10_500.jpg (84677 021 30ol Dapa Met Tab 10 500)
Label for Dapagliflozin and Metformin Hydrochloride 10 mg/500 mg extended-release film-coated tablets. The label includes dosage instructions, storage conditions, and manufacturer details (Golden State Medical Supply, Inc., California). Contains 30 tablets, Rx only, with a barcode and child-resistant packaging warning.*
FDA Label Image

84677-022-30lb- Dapa_met Tab 10_1000.jpg (84677 022 30lb Dapa Met Tab 10 1000)

84677-022-30lb- Dapa_met Tab 10_1000.jpg (84677 022 30lb Dapa Met Tab 10 1000)
Label for Dapagliflozin and Metformin Hydrochloride extended-release tablets, 10 mg/1000 mg strength. The label shows a package of 30 film-coated tablets by Golden State Medical Supply, Inc. Contains usage instructions, storage conditions, and manufacturer information including marketing by GSMS, Incorporated in Camarillo, CA. The label also includes the NDC 84677-022-30 and warnings against crushing or cutting tablets.*
FDA Label Image

Dapagliflozin Structural Formula (Dapagliflozin Structural Formula)

Dapagliflozin Structural Formula (Dapagliflozin Structural Formula)
Chemical structure diagram of the active ingredient dapagliflozin, showing its molecular framework including hydroxyl groups, aromatic rings, and chlorine substitution.*
FDA Label Image

Figure 1 (Figure 1)

Figure 1 (Figure 1)
A scatter plot with fitted lines showing the relationship between Dapagliflozin dose (mg) on a logarithmic x-axis and CFB in 24-Hr Urinary Glucose (g) on the y-axis. Data points represent observed values for healthy subjects (circles) and subjects with T2DM (stars). The graph includes fitted dose-response lines for both groups.*
FDA Label Image

Figure 2 (Figure 2)

Figure 2 (Figure 2)
A line graph showing the adjusted mean change in HbA1c percentage from baseline over a 24-week study period. The graph compares three treatment groups: Dapagliflozin 10 mg plus Metformin XR, Dapagliflozin 10 mg, and Metformin XR alone. The x-axis represents study weeks (0 to 24) and the y-axis measures HbA1c change from baseline. The graph shows a decreasing trend in HbA1c for all groups, with Dapagliflozin 10 mg plus Metformin XR exhibiting the greatest reduction. A right-side inset presents Week 24 LOCF (Last Observation Carried Forward) values with 95% confidence intervals for the three groups.*
FDA Label Image

Figure 4 (Figure 4)

Figure 4 (Figure 4)
A line graph showing the percentage of patients with events over time in months from randomization, comparing Dapagliflozin to Placebo. The y-axis represents percentage of patients with events, and the x-axis shows time in months, up to 60. The graph includes a table below indicating the number of patients at risk for Dapagliflozin and Placebo groups at various time points.*
FDA Label Image

Figure 5 (Figure 5)

Figure 5 (Figure 5)
A line graph comparing the percentage of patients with an event over time between Dapagliflozin and placebo groups. The x-axis shows months from randomization, ranging to 60 months, and the y-axis shows the percentage of patients with an event. A table below lists the number of patients at risk for each group at several time points.*
FDA Label Image

Figure 6 (Figure 6)

Figure 6 (Figure 6)
A line graph comparing the percentage of patients with events over months from randomization between dapagliflozin and placebo groups. The y-axis shows patients with event (%) and the x-axis shows months from randomization up to 32 months. Two curves represent dapagliflozin (lower solid line) and placebo (higher dashed line), with a hazard ratio (HR) of 0.61 (95% CI: 0.51, 0.72). A table below shows the number of patients at risk for each group at various time points.*
FDA Label Image

Figure 7a (Figure 7a)

Figure 7a (Figure 7a)
A Kaplan-Meier plot comparing the percentage of patients with an event over time in months from randomization between Dapagliflozin and placebo groups. The graph shows fewer events in the Dapagliflozin group over approximately 30 months. Hazard ratio (HR) with 95% confidence interval and p-value are provided comparing Dapagliflozin versus placebo. Patient numbers at risk at specified time points are listed below the x-axis.*
FDA Label Image

Figure 7b (Figure 7b)

Figure 7b (Figure 7b)
A Kaplan-Meier curve comparing the percentage of patients with an event over 36 months from randomization for dapagliflozin versus placebo. The graph shows two lines, with placebo consistently having a higher event rate than dapagliflozin. Below the graph, the number of patients at risk at multiple time points is displayed for both groups. The hazard ratio (HR) with 95% confidence interval (CI) and p-value are noted, comparing dapagliflozin to placebo.*
FDA Label Image

Figure 8 (Figure 8)

Figure 8 (Figure 8)
A forest plot figure illustrating hazard ratios (HR) with 95% confidence intervals for Dapagliflozin compared to placebo across different left ventricular ejection fraction (LVEF) percentage categories in DAPA-HF and DELIVER studies. The x-axis shows HR values from 0.5 to 2, comparing Dapagliflozin better to placebo better, with data points and corresponding numeric HR values listed for each category.*
FDA Label Image

Metformin HCl Structural Formula (Metformin HCl Structural Formula)

Metformin HCl Structural Formula (Metformin HCl Structural Formula)
Chemical structure diagram of Metformin Hydrochloride, showing its molecular arrangement including methyl groups, amino groups, and the hydrochloride component.*

* 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.