Dapagliflozin And Metformin Hydrochloride Tablet, Extended Release
Product Images NDC 33342-409

Product Visual Gallery

This gallery contains 31 technical images submitted to the FDA as part of the official labeling for Dapagliflozin And Metformin Hydrochloride (NDC 33342-409). 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

505 (Dapa Met Er 10mg 1000mg 30s Container)

This text is a description of a medication called Dapagliflozin and Metformin HCI Extended-Release tablets. It includes information for pharmacists to dispense a Medication Guide to each patient, instructions not to crush or chew tablets, details on dosage, storage conditions, and manufacturing information. This medication contains 10 mg of dapagliflozin and 1000 mg of metformin hydrochloride per tablet. Detailed dosage instructions can be found in the package insert.*

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505 (Dapa Met Er 10mg 1000mg 500s Container)

This is a medication containing 10 mg of dapagliflozin and 1000 mg of metformin hydrochloride. It should be stored at 20° to 25°C (68° to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). The tablets are extended-release and should be dispensed in a tightly closed container. The package is not child-resistant and should be kept out of reach of children. The tablets must be swallowed whole. The product is manufactured in India and distributed by Macleods Pharma USA, Inc.*

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1515 (Dapa Met Er 10mg 1000mg 60s Container)

This is a medication package containing Dapagliflozin and Metformin HCI extended-release tablets. Each tablet has 10 mg of dapagliflozin and 1000 mg of metformin hydrochloride. The usual storage temperature is 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 tablets should not be crushed, cut, or chewed; they must be swallowed whole. Manufacturer information indicates that these tablets are manufactured by Macleods Pharmaceuticals Ltd for Macleods Pharma USA, Inc.*

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505 (Dapa Met Er 10mg 1000mg 90s Container)

Each tablet contains 10 mg dapagliflozin and 1000 mg metformin hydrochloride. The recommended dosage is available on the package insert for Metformin HCI. These extended-release tablets should be stored between 20° to 25°C (68° to 77°F). It is important not to crush, cut, or chew the tablets, they must be swallowed whole. Manufactured by Macleods Pharmaceuticals Ltd, the medication is made in India. The bottles come with an inner seal, and it should not be used if broken or missing. More information can be found on the Medication Guide at www.macleodspharma.com/usa.*

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1717 (Dapa Met Er 10mg 1000mg Carton Tablets)

This is information about Dapagliflozin and Metformin HCI Extended-Release Tablets containing 10 mg/1000 mg. The tablets are manufactured by Macleods Pharma USA, Inc. in Princeton, NJ, and also by Macleods Pharmaceuticals Ltd in Baddi, Himachal Pradesh, India. The storage instructions recommend storing them at room temperature between 15-30°C (59-86°F). The text also mentions dosage guidance provided on the package.*

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505 (Dapa Met Er 10mg 500mg 30s Container)

This is a product label for tablets containing 10 mg dapagliflozin and 500 mg metformin hydrochloride. It provides dosage instructions, storage recommendations, and manufacturer information. Tablets should be swallowed whole and not chewed or cut. The instructions also emphasize not using the tablets if the inner seal of the bottle is broken or missing. The product is manufactured by Macleods Pharmaceuticals Ltd. in India.*

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505 (Dapa Met Er 10mg 500mg 500s Container)

This is a description of the medication: Dapagliflozin and Metformin HCI Extended-Release Tablets 10 mg/500 mg. The pharmacist is advised to dispense the accompanying Medication Guide to each patient. The tablets should not be crushed, cut, or chewed, and must be swallowed whole. Each tablet contains 10 mg dapagliflozin and 500 mg metformin. The usual dosage instructions can be found in the package insert. The tablets should be stored at 20° to 25°C (68° to 77°F) with excursions allowed between 15° to 30°C (59° to 86°F). The medication should be dispensed in a tightly closed container and kept out of reach of children. The product is manufactured in India by Macleods Pharma USA, Inc. and Macleods Pharmaceuticals Ltd.*

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505 (Dapa Met Er 10mg 500mg 60s Container)

This text provides information about a medication called Dapagliflozin and Metformin HCI. Each tablet contains 10 mg of dapagliflozin and 500 mg of metformin hydrochloride. The usual dosage instructions are available in the package insert. It is an extended-release tablet that should be stored at 20° to 25°C. The pharmacist should dispense the accompanying Medication Guide to each patient. It is important not to crush, cut, or chew the tablets; they must be swallowed whole. The product is manufactured in India for Macleods Pharma USA, Inc.*

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505 (Dapa Met Er 10mg 500mg 90s Container)

This is a description for a medication that contains 500 mg of metformin hydrochloride in extended-release tablets. The usual dosage should be followed, and the tablets should be stored at temperatures between 20° to 25°C (68° to 77°F). The medication should not be crushed, cut, or chewed and must be swallowed whole. Additional dosage information can be found in the package insert. Manufactured by Macleods Pharmaceuticals Ltd. in India, the product is available in a bottle containing 90 tablets. For more details, refer to the accompanying Medication Guide at www.macleodspharma.com/usa.*

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8888 (Dapa Met Er 10mg 500mg Carton Tablets)

This is a description of Dapagliflozin and Metformin HCI Extended-Release Tablets. The tablets are manufactured by Macleods Pharma in the USA and India. Each tablet contains dapagliflozin 10 mg and metformin 500 mg. The recommended storage temperature is 25°C (77°F). The package is a single-dose package and should be stored at controlled room temperature.*

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505 (Dapa Met Er 5mg 1000mg 30s Container)

This text appears to be a description for a medication containing 5 mg dapagliflozin and 1000 mg metformin hydrochloride in each tablet, with details on storage conditions, dosage, and instructions for use. The product is distributed by Macleods Pharma USA, Inc., with a website available for further information. The tablets are not to be crushed, cut, or chewed and must be swallowed whole. The manufacturing location is indicated as Macleods Pharmaceuticals Ltd. in India. The National Drug Code (NDC) for this medication is 33342-408-07.*

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505 (Dapa Met Er 5mg 1000mg 500s Container)

This is a description of a medication named "Dapagliflozin and Metformin HCI Extended-Release Tablets," containing 5 mg of dapagliflozin and 1000 mg of metformin hydrochloride per tablet. The dosage instructions are to not crush, cut, or chew the tablets, and they must be swallowed whole. It is recommended to dispense the medication guide available online to each patient. The usual dosage information can be found in the package insert. The tablets should be stored between 20° to 25°C (68° to 77°F). The product is manufactured in India and distributed by Macleods Pharma USA, Inc. It is important to keep the medication out of reach of children and not use it if the inner seal of the bottle is broken or missing.*

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505 (Dapa Met Er 5mg 1000mg 60s Container)

This is a description of a medication containing dapagliflozin and metformin HCI, with each tablet having 5 mg of dapagliflozin and 1000 mg of metformin hydrochloride. The usual dosage instructions can be found in the package insert. The tablets are extended-release and should be stored at 20° to 25°C. Pharmacists are advised to dispense the accompanying Medication Guide to each patient. It is important not to crush, cut, or chew the tablets; they must be swallowed whole. The product should not be used if the printed inner seal of the bottle is broken or missing. This medication is a product of India and is manufactured by Macleods Pharmaceuticals Ltd. The available information suggests that the medication comes in a bottle with 60 tablets and needs to be stored at 15° to 30°C.*

FDA Label Image

505 (Dapa Met Er 5mg 1000mg 90s Container)

Each tablet contains 5 mg dapagliflozin and 1000 mg metformin hydrochloride. This medication is in the form of extended-release tablets with specific storage instructions. The recommended usual dosage and further details can be found in the package insert. It is important not to crush, cut, or chew the tablets, as they should be swallowed whole. The medication is manufactured for Macleods Pharma USA, Inc. and is a product of India. More information and a Medication Guide are available on their website.*

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1313 (Dapa Met Er 5mg 1000mg Carton Tablets)

This text appears to be a label or package insert for Dapagliflozin and Metformin HCI Extended-Release Tablets. The tablets are manufactured by Macleods Pharma USA, Inc. located in Princeton, NJ, with manufacturing also done in India. The text also includes instructions on storage temperature and dosage information.*

FDA Label Image

505 (Dapa Met Er 5mg 500mg 30s Container)

Each tablet in this medication contains 5 mg of dapagliflozin and 500 mg of metformin hydrochloride. It is recommended to refer to the package insert for full dosage information. The tablets should be stored at room temperature between 20 to 25°C (68° to 77°F), with excursions permitted between 15° to 30°C (59° to 86°F). The accompanying Medication Guide should be provided to each patient. It is important not to crush, cut, or chew the tablets, they must be swallowed whole. This medication is manufactured by Macleods Pharma USA, Inc.*

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505 (Dapa Met Er 5mg 500mg 500s Container)

This text provides information about Dapagliflozin and Metformin HCI Extended-Release Tablets in the strength of 5 mg/500 mg. It includes details on dosage, storage instructions, and the manufacturer. The medication guide for patients and the importance of not crushing or chewing the tablets are emphasized. The text also mentions the need to keep the tablets in a tightly closed container and out of reach of children.*

FDA Label Image

505 (Dapa Met Er 5mg 500mg 60s Container)

This is a description of Dapagliflozin and Metformin HCI Extended-Release Tablets with a dosage of 5 mg/500 mg. The medication is for oral use and each tablet contains dapagliflozin and metformin hydrochloride. It is important not to crush, cut, or chew the tablets, as they must be swallowed whole. The usual dosage information can be found in the package insert. The tablets should be stored at temperatures between 20°C to 25°C (68°F to 77°F), with permissible excursions between 15°C to 30°C (59°F to 86°F). The product is manufactured in India for Macleods Pharma USA, Inc. and caution is advised not to use the tablets if the printed inner seal of the bottle is broken or missing.*

FDA Label Image

505 (Dapa Met Er 5mg 500mg 90s Container)

This text provides information about a medication that contains 5 mg of dapagliflozin and 500 mg of metformin hydrochloride in each tablet. The usual dosage and storage instructions are included. It also mentions the manufacturer and provides a website to access the medication guide. The tablets should be swallowed whole and should not be crushed, cut, or chewed.*

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3333 (Dapa Met Er 5mg 500mg Carton Tablets)

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Dapa (Dapa Met Er Dapagliflozin Str)

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505 (Dapa Met Er Figur 1)

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505 (Dapa Met Er Figure 2)

This is a display of data comparing the adjusted mean change from baseline HbA1c (%) values over 24 weeks for subjects using Dapagliflozin 10 mg + Metformin XR, Dapagliflozin 10 mg, and Metformin XR. The information is presented in graphs showing the mean change based on a repeated measures model for subjects who completed the study without rescue intervention. The right side graph specifically portrays the values for the mean change at Week 24 using last observation carried forward (LOCF) method and 95% confidence intervals.*

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505 (Dapa Met Er Figure 3)

This text provides information on the adjusted mean change from baseline HbA1c (%) over the study weeks for two groups - PLACEBO + METFORMIN and DAPAGLIFLOZIN 10 MG + METFORMIN. The data includes graphs showing values for adjusted mean change from baseline based on a longitudinal repeated measures model and an ANCOVA model. The study evaluated subjects completing the Short-Term Period without rescue, with both baseline and Week 24 values, providing valuable insights into the impact of the treatments on HbA1c levels.*

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505 (Dapa Met Er Figure 6)

This is a tabular presentation of clinical trial data comparing the effects of Dapagliflozin versus Placebo on patients over a period of time from randomization. The table shows the number of patients at risk at various time intervals starting from 0 months up to 32 months. It also includes information on the percentage of patients with events and the Hazard Ratio with a 95% Confidence Interval. The data can be useful for evaluating the efficacy and safety of Dapagliflozin compared to placebo in a clinical setting.*

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505 (Dapa Met Er Figure 7a)

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505 (Dapa Met Er Figure 7b)

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505 (Dapa Met Er Figure 8)

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525 (Dapa Met Er Figure4)

This is a clinical study report showing the number of patients at risk over several months after randomization for two groups: Dapagliflozin and Placebo. The data provides insight into the course of the study and the number of patients remaining in each group at specific time points.*

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505 (Dapa Met Er Figure5)

This is a set of data related to a medical study, likely in a clinical trial evaluating the efficacy of a drug called "Dapagliflozin" compared to a placebo. The text includes different time points (24, 30, 36, 42 months from randomization) along with the number of patients at risk in each group. The numbers seem to represent the patients with a certain event or those who remained unaffected during the study at different intervals. The total number of patients at risk in the Dapagliflozin group is 8582 and in the Placebo group is 8578, with decreasing counts at subsequent time points.*

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Dapa-met-er-met-structure (Dapa Met Er Metformin Structure)

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