Dapagliflozin And Metformin Hydrochloride Tablet, Film Coated, Extended Release
Product Images NDC 59651-154

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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 59651-154). 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)

Figure 1 (Dapagmet Fig1)
This is about evaluating CFB in 24-Hr Urinary Glucose levels measured in grams, potentially associated with Dapagliflozin dosage (mg). The data includes observed values for both healthy subjects and those with T2DM, along with fitted lines for each group. There seems to be a distinction between the glucose levels for healthy subjects and those with T2DM across different dosages.*
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Package Label-principal Display Panel (5 mg/ 500 mg)

Package Label-principal Display Panel (5 mg/ 500 mg)
This is a description of a medication called Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets with a formulation of 5 mg Dapagliflozin and 500 mg metformin hydrochloride. It is distributed by Aurobindo Pharma USA and is intended for controlled room temperature storage. The tablets should not be crushed, cut, or chewed, and must be swallowed whole. Patients are advised to refer to the package insert for full dosage information. The text also mentions the location of the manufacturer in East Windsor, NJ, and provides a code for reference. Additionally, it instructs that a medication guide must be provided with each patient, and certain details such as GTIN and expiry date will be printed on the packaging.*
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Package Label-principal Display Panel (5 mg/ 1000 mg)

Package Label-principal Display Panel (5 mg/ 1000 mg)
This is information about an extended-release tablet containing Dapagliflozin 5 mg and Metformin hydrochloride USP 1000 mg. It is distributed by Aurobindo Pharma USA, Inc. The tablets should not be crushed, cut, or chewed but swallowed whole. It is advisable to store them at 20°C to 25°C (66°F to 77°F) and each patient should be provided with a Medication Guide. The tablets are manufactured in India. The package insert provides the usual dosage and important information about the medication.*
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Package Label-principal Display Panel (10 mg/ 500 mg)

Package Label-principal Display Panel (10 mg/ 500 mg)
Each film-coated extended-release tablet contains Dapagliflozin 10 mg and metformin hydrochloride USP 500 mg. It is made by Aurobindo Pharma USA, Inc. The usual dosage information can be found in the package insert. Store the tablets at 20° to 25°C. The medication is dispensed with a Medication Guide and should not be crushed, cut, or chewed - they must be swallowed whole. The tablets are distributed from East Windsor, NJ and are made in India. Provide the medication guide to each patient separately. Serialization details are printed during packing.*
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Package Label-principal Display Panel (10 mg/ 1000 mg)

Package Label-principal Display Panel (10 mg/ 1000 mg)
Each film-coated extended-release tablet Distributed by Aurobindo Pharma USA contains Dapagifiozin 10 mg and metformin hydrochioride USP 1000 mg. The product is manufactured in India and must be stored at 20° to 25°C. It's important to take the tablets whole, without crushing, cutting, or chewing them. For more detailed dosage information, refer to the package insert provided. The unique code AP/DRUGS/04/2016 is associated with this medication. Additionally, the medication guide should be provided to each patient, and the inner seal of the bottle should be checked before use.*
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Figure 2 (Dapagmet Fig2)

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Figure 3 (Dapagmet Fig3)

Figure 3 (Dapagmet Fig3)
This text provides information on the adjusted mean change from baseline HbA1c (%) for subjects in a study comparing the effects of placebo + metformin versus dapagliflozin 10 mg + metformin. The data presented includes graphs showing the adjusted mean change over time and at Week 24 using different statistical models and criteria for subject inclusion. The study seems to focus on the Short-Term Period and includes a longitudinal repeated measures model on one side and an ANCOVA model on the other. The results aim to showcase the impact of the treatments on HbA1c levels.*
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Figure 4: Time To First Occurrence Of Hospitalization For Heart Failure Or Cv Death In The Declare Study (Dapagmet Fig4)

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

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Figure 6 (Dapagmet Fig6)

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

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Figure 7 B) Deliver Trial (Dapagmet Fig8)

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Figure 8 (Dapagmet Fig9)

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Chemical Structure1 (Dapagmet Str1)

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Chemical Structure2 (Dapagmet Str2)

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