Dapagliflozin And Metformin Hydrochloride Tablet, Film Coated, Extended Release
Product Images NDC 67877-621

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 67877-621). 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.

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Dapagliflozin-30tab-a (Dapagliflozin 30tab A)

This text provides information about a tablet containing 5 mg of dapagliflozin and 500 mg of metformin hydrochloride. It includes guidelines for dosage, storage conditions, and manufacturer details. The tablet should not be used if the inner seal is broken or missing. The product is manufactured by Alkem Laboratories Ltd in Mumbai, India, and distributed by Ascend Laboratories LLC in Bedminster, NJ.*

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

This text provides crucial information about a medication containing 10 mg of dapagifiozin and 500 mg of metformin hydrochloride. It includes instructions for storage, dosage, and dispensing, cautioning against use if the inner seal is broken. The manufacturer is Alkem Laboratories Ltd. in Mumbai, India, and the distributor is Ascend Laboratories in Bedminster, NJ. The prescription-only tablets are to be swallowed whole and come with an extended-release formula.*

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

Each tablet contains the equivalent of 5 mg of dapaglifozin and 1000 mg of metformin hydrochloride. Usual Dosage: Refer to the package insert for detailed dosage instructions. Store between 20°C to 25°C (68°F to 77°F). Do not use if the inner seal of the bottle is missing or broken. Manufactured by Alkem Laboratories Ltd., Mumbai, India. Distributed by Ascend Laboratories, LLC, Bedminster, NJ. The tablets should not be crushed, cut, or chewed and must be swallowed whole. The product is an extended-release tablet. Remember to dispense the enclosed Medication Guide to each patient.*

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

This text is a detailed prescription information for Dapagliflozin and Metformin HCI Extended-Release Tablets containing 10 mg of Dapagliflozin and 1000 mg of Metformin. It provides dosage instructions, storage conditions, and information on dispensing the enclosed Medication Guide to patients. The tablets should not be crushed, cut, or chewed and must be swallowed whole. The packaging includes 100 tablets in a unit-dose container, and it mentions that the unit-dose package is not child-resistant for outpatient use. It also includes manufacturing and distribution information.*

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Dapagliflozin-fig-1 (Dapagliflozin Fig 1)

This is information related to the measurement of CFB in 24-hour urinary glucose (g) along with dapagliflozin dose in milligrams (mg). The data includes observed values for healthy subjects and subjects with T20M, as well as fitted lines for both groups. The text also contains numerical values and references to plots.*

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

This is a description of a study evaluating the adjusted mean change in HbA1c (%) levels from baseline over a period of 24 weeks for subjects using Dapagliflozin 10 mg + Metformin XR, Dapagliflozin 10mg alone, and Metformin XR alone. The study includes graphs showing values for adjusted mean change from baseline based on a longitudinal repeated measures model and Week 24 values based on an ANCOVA model. The study includes randomized subjects who completed the study without rescue intervention.*

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

This text provides information on the adjusted mean change from baseline in HbA1c levels for subjects in a study comparing the effects of placebo + metformin versus dapagliflozin 10 mg + metformin. The data is displayed on two graphs, one showing results based on a longitudinal repeated measures model, and the other showing values for adjusted mean change from baseline at Week 24 with 95% confidence intervals based on an ANCOVA model. The graphs include values at various time points and detail the subjects included in the analysis.*

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Dapagliflozin-figure 4 (Dapagliflozin Figure 4)

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Dapagliflozin-figure 5 (Dapagliflozin Figure 5)

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Dapagliflozin-figure-6 (Dapagliflozin Figure 6)

This is a chart showing the comparison between Dapagliflozin and Placebo over time, in terms of HR (hazard ratio) with a 95% confidence interval. The chart displays the number of patients at risk for each treatment group at different time points. It seems to be related to a clinical trial or study evaluating the efficacy of Dapagliflozin compared to Placebo in the treatment of a certain condition.*

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

This appears to be a statistical comparison between patients receiving Dapagliflozin and placebo over a period of months. The text shows the number of patients at risk at various time points, as well as event percentages for each group. The data seems to indicate a significant difference between Dapagliflozin and placebo groups based on the hazard ratio and p-value provided.*

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

This is a statistical data chart comparing the effect of Dapagliflozin versus Placebo on patients with an event over the course of several months. The chart includes the number of patients at risk at different time points and provides information on hazard ratio, confidence intervals, and p-values for the comparison.*

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Dapagliflozin-figure-8 (Dapagliflozin Figure 8)

This is a comparison of different studies on heart failure patients, focusing on Left Ventricular Ejection Fraction (LVEF) percentages. It includes data on two trials, DAPA-HF and DELIVER, showing the LVEF categories, number of participants, and results comparing the effectiveness of the drug Dapagliflozin versus a placebo. The results are presented as Hazard Ratios (HR) and Confidence Intervals (CI), indicating the efficacy of Dapagliflozin compared to the placebo in improving heart failure outcomes. This information is valuable for healthcare professionals and researchers studying heart failure treatments.*

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Dapagliflozin-metformin-a (Dapagliflozin Metformin A)

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Dapagliflozin-structure-a (Dapagliflozin Structure A)

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.