Figure 1: Scatter Plot And Fitted Line Of Change From Baseline In 24-hour Urinary Glucose Amount Versus Dapagliflozin Dose In Healthy Subjects And Subjects With Type 2 Diabetes Mellitus (t2dm) (semi-log Plot) (Dapagliflozin Fig1)
Dapagliflozin Tablet, Film Coated
Product Images NDC 59651-159
View Photos of Packaging, Regulatory Labels, and Product Appearance
Product Visual Gallery
This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Dapagliflozin (NDC 59651-159). 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.
Product Images & Figures Index
Figure 2: Adjusted Mean Change From Baseline Over Time In Hba1c (%) In A 24-week Active-controlled Study Of Dapagliflozin Initial Combination Therapy With Metformin Xr (Dapagliflozin Fig2)
The text provides information on the adjusted mean change from baseline for different treatments over several study weeks. It includes graphs displaying values for adjusted mean change from baseline based on different models and criteria for inclusion of subjects in the analysis. The information is important for assessing the effectiveness and impact of treatments on the study subjects.*
Figure 3 (Dapagliflozin Fig3)
Figure (Dapagliflozin Fig4)
Figure (Dapagliflozin Fig5)
Package Label-principal Display Panel (5 mg)
This text provides information about a medication called Dapagliflozin Tablets 5mg. It includes guidance for pharmacists to dispense the medication with a guide provided separately to each patient. The tablets should be stored at 20°C to 25°C (68°F to 77°F). The label also indicates the manufacturer as Aurobindo Pharma USA, Inc. and mentions that the medication is made in India. It clarifies that the usual dosage information can be found in the package insert and warns not to use if the printed inner seal of the bottle is broken or missing. Additionally, it includes details for printing medication guides and mentions that GTIN, Serial Number, Expiry Date, and LOT will be printed during packing.*
Package Label-principal Display Panel (10 mg)
This is information related to a medication called Dapagliflozin Tablets, each containing 10 mg of dapagliflozin. The tablets are distributed by Aurobindo Pharma USA, Inc. and are meant to be dispensed to patients based on a medication guide provided separately. The usual dosage information can be found in the package insert. It is recommended to store the tablets at a temperature between 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C and 30°C (59°F and 86°F). The medication should not be used if the printed inner seal of the bottle is broken or missing. Furthermore, the production was in India with the code AP/DRUGS/04/2016. Additional detail such as the manufacturer's website for medication guides and a unique product code (P1419711) are provided as well.*
Chemical Structure (Dapagliflozin Str)
* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.
