Dapagliflozin And Metformin Hydrochloride Tablet, Film Coated, Extended Release
Product Images NDC 59651-156

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 59651-156). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aurobindo Pharma 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

Figure 1 (Dapagmet Fig1)

A graph displaying the relationship between dapagliflozin dose (mg) on a logarithmic x-axis and change from baseline (CFB) in 24-hour urinary glucose (g) on the y-axis. It shows observed values for healthy subjects and subjects with type 2 diabetes mellitus (T2DM) using different symbols, along with fitted trend lines for each group.*

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Package Label-principal Display Panel (5 mg/ 500 mg)

Label for Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets, 5 mg/500 mg, film-coated tablet, packaged in a 30-tablet bottle. Label includes dosing guidance, storage conditions, distributor details (Aurobindo Pharma USA, Inc.), and a barcode. Tablets are Rx only and must be swallowed whole.*

FDA Label Image

Package Label-principal Display Panel (5 mg/ 1000 mg)

Label for Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets, 5 mg/1000 mg strength. The film-coated tablet package contains 30 tablets. Distributed by Aurobindo Pharma USA, Inc., made in India. The label includes usage instructions, storage conditions, and warnings about tablet handling and product sealing. A barcode is shown on the right side.*

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Package Label-principal Display Panel (10 mg/ 500 mg)

Label for Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets 10 mg/500 mg, film-coated oral tablets. The label states it is for Rx only and provides storage instructions and distributor information for Aurobindo Pharma USA, Inc. The package contains 30 tablets. Additional instructions include not crushing or chewing tablets and dispensing the Medication Guide separately.*

FDA Label Image

Package Label-principal Display Panel (10 mg/ 1000 mg)

Label for Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets 10 mg/1000 mg by Aurobindo Pharma Limited. The label states dosage form as film-coated extended-release tablets, includes pharmacy dispensing instructions, storage conditions, and distributor information for Aurobindo Pharma USA, Inc. It also notes a package size of 30 tablets and has a barcode on the right side.*

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Figure 2 (Dapagmet Fig2)

A line graph depicting the adjusted mean change in HbA1c (%) from baseline over 24 weeks for three treatments: Dapagliflozin 10 mg + Metformin XR, Dapagliflozin 10 mg, and Metformin XR. The x-axis shows study weeks from 0 to 24, and the y-axis shows HbA1c change from 0 to -2.0%. A side graph presents Week 24 data with 95% confidence intervals. The graph compares efficacy trends over time for these treatments.*

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Figure 3 (Dapagmet Fig3)

A line graph comparing adjusted mean change from baseline HbA1c (%) over 24 weeks between two treatment groups: Placebo plus Metformin and Dapagliflozin 10 mg plus Metformin. The graph shows a greater reduction in HbA1c for the Dapagliflozin plus Metformin group throughout the study. A smaller inset presents Week 24 adjusted mean changes with 95% confidence intervals for both groups.*

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Figure 4: Time To First Occurrence Of Hospitalization For Heart Failure Or Cv Death In The Declare Study (Dapagmet Fig4)

A line graph comparing the cumulative percentage of patients with an event over a 60-month period after randomization between Dapagliflozin and placebo groups. The x-axis represents months from randomization, and the y-axis shows the percentage of patients with the event. Patient risk counts at various time points are listed below the graph for both groups.*

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Figure 5: Time To First Occurrence Of Hospitalization For Heart Failure In The Declare Study (Dapagmet Fig5)

A line graph comparing the percent event risk over 60 months from randomization between two groups: Placebo and Dapagliflozin. The y-axis represents percent event risk (%) ranging from 0 to 4.5%, and the x-axis represents months from randomization ranging from 0 to 60. The graph shows lower event risk for the Dapagliflozin group compared to the Placebo group throughout the study period.*

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Figure 6 (Dapagmet Fig6)

A Kaplan-Meier curve comparing the percentage of patients experiencing an event over 32 months between Dapagliflozin and Placebo groups. The graph shows a lower event rate for Dapagliflozin compared to Placebo. Patient numbers at risk are listed below the x-axis at various time points from randomization.*

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Figure 7 A) Dapa-hf Trial (Dapagmet Fig7)

A Kaplan-Meier curve chart comparing the percentage of patients with events over 36 months from randomization between Dapagliflozin and Placebo. The graph shows a lower event rate with Dapagliflozin, including hazard ratio (HR 0.74) with confidence intervals and a significant p-value (<0.0001). Patient numbers at risk over time are displayed below the x-axis.*

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Figure 7 B) Deliver Trial (Dapagmet Fig8)

A line graph comparing the percentage of patients with events over 36 months between Dapagliflozin and Placebo groups in a clinical study. The graph plots time in months on the x-axis and percentage of patients on the y-axis, showing a lower event rate in the Dapagliflozin group. Numbers of patients at risk for each group are listed below the x-axis.*

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Figure 8 (Dapagmet Fig9)

A forest plot comparing hazard ratios (HR) with 95% confidence intervals for dapagliflozin versus placebo across different left ventricular ejection fraction (LVEF) categories and the DELIVER study groups. The plot visually represents the relative effectiveness of dapagliflozin compared to placebo for each subgroup, with markers and confidence intervals displayed on a horizontal axis ranging from 0.5 to 2.0.*

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Chemical Structure1 (Dapagmet Str1)

Chemical structure diagram of Dapagliflozin, one of the active ingredients in the combination drug Dapagliflozin and Metformin hydrochloride.*

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Chemical Structure2 (Dapagmet Str2)

Chemical structure of Metformin hydrochloride, showing its molecular composition including methyl, amine, and guanidine groups along with an attached HCl 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.