Dapagliflozin Tablet
Product Images NDC 33342-586

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Dapagliflozin (NDC 33342-586). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Macleods Pharmaceuticals 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

336 (Dapagliflozin 10 mg 140 S)

This text appears to be a description of Dapagliflozin tablets manufactured by Macleods Pharma in USA. The tablets contain Dapagliflozin 10 mg and should be stored at 20-25°C. The product information, including batch number and expiration date, is provided for pharmacists to dispense to patients. For more information, a Medication Guide is available on the official website. It is important to keep this medication out of reach of children as the unit-dose package is not child-resistant.*

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852 (Dapagliflozin 10 mg 30 S)

This is a medication description for film-coated tablets containing 10 mg of Dapagliflozin. The recommended dosage is advised to be obtained from the prescribing information. The tablets should be stored at controlled room temperature, between 15°C to 30°C (59°F to 86°F). The pharmacist's instructions include dispensing the medication along with the Medication Guide and keeping it out of reach of children. The product is manufactured by Macleods Pharma USA, Inc. and Macleods Pharmaceuticals Ltd.*

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564 (Dapagliflozin 10 mg 90 S)

This text provides information about a medication called Dapagliflozin, which comes in tablet form. It includes details such as the recommended dosage, storage instructions, manufacturer information, and a website link to access the Medication Guide. The tablets contain 10 mg of Dapagliflozin and should be kept at a temperature of 20°C to 25°C. The product is manufactured in India by Macleods Pharma USA, Inc., and the inner seal of the bottle should not be used if broken.*

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448 (Dapagliflozin 5 mg 100 S)

This is a description of Dapagliflozin Tablets containing 5mg of Dapagliflozin per tablet. The tablets are manufactured by Macleods Pharmaceuticals Ltd in India and distributed by Macleods Pharma USA, Inc. It is advised to store the tablets between 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C to 30°C (59°F to 86°F). The recommended dosage and additional safety information can be found in the prescribing information available online. Each package contains 100 tablets in 10 blister cards with 10 tablets per card.*

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723 (Dapagliflozin 5 mg 30 S)

This text provides information about dapagliflozin tablets, each containing 5mg of the active ingredient. It includes details on the recommended dosage, storage conditions, and safety precautions such as keeping the medication out of reach of children. The product is manufactured by Macleods Pharma in India and distributed in the USA. Additionally, it mentions the availability of a Medication Guide for patients and carries a specific NDC code for identification.*

FDA Label Image

656 (Dapagliflozin 5 mg 90 S)

This is a description of a film-coated tablet containing Dapagliflozin 5mg, manufactured by Macleods Pharma USA. The recommended dosage information is provided along with storage instructions. The tablet should be kept at controlled room temperature and protected from moisture. Dispensing instructions for pharmacists are also included. The product is made in India and comes in a bottle containing 90 tablets. For more details, visit the manufacturer's website.*

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505 (Dapagliflozin Fig 1)

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658 (Dapagliflozin Fig 2)

This is a description of a study evaluating the adjusted mean change in HbA1c levels over a 24-week period in participants using Dapagliflozin 10 mg + Metformin or Dapagliflozin 10 mg alone. The analysis includes data based on a longitudinal repeated measures model and ANCOVA model. The study compares the mean changes from baseline HbA1c levels and provides insights into the efficacy of the treatments.*

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575 (Dapagliflozin Figure 3)

The text provides data comparison between the effects of placebo + metformin and dapagliflozin 10 mg + metformin on HbA1c values after a Short-Term Period. It includes graphs showing adjusted mean change from baseline at Week 24 for both groups based on different models. These results are from a study involving subjects who completed the Short-Term Period without needing rescue intervention.*

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505 (Dapagliflozin Figure 4)

This is not-readable.*

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505 (Dapagliflozin Figure 5)

This is a figure showing the comparison of the efficacy of Dapagliflozin versus Placebo over a span of 60 months. The chart includes the number of patients at risk for each treatment group at different time points, with the y-axis indicating the percentage of patients with events. The data suggests a trend favoring Dapagliflozin compared to Placebo in the specified duration.*

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556 (Dapagliflozin Stru)

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