Jardiance Tablet, Film Coated
Product Images NDC 71610-900

Product Visual Gallery

This gallery contains 18 technical images submitted to the FDA as part of the official labeling for Jardiance (NDC 71610-900). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aphena Pharma Solutions - Tennessee, 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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Label (71610 0900 09)

Jardiance (Empagliflozin) 10 mg film-coated tablets label from Aphena Pharma Solutions - Tennessee, LLC. The label indicates a package size of 9000 tablets with NDC 71610-900-09. Storage instructions specify temperatures between 20-25°C and keeping the product out of reach of children. The label includes manufacturer and repackager information and barcodes for product identification.*

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Aphena (Aphena)

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Chemical Structure (Jardiance 01)

Chemical structure diagram of Empagliflozin, the active ingredient in Jardiance 10 mg oral film-coated tablets, showing molecular bonds, aromatic rings, hydroxyl groups, and a chlorine atom.*

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Figure 1 (Jardiance 02)

A forest plot showing the geometric mean ratio with 90% confidence intervals of various drugs' pharmacokinetic parameters (AUC and Cmax) relative to empagliflozin alone. The plot includes antidiabetic drugs like metformin, glimepiride, pioglitazone, sitagliptin, linagliptin, and other drugs such as simvastatin, warfarin, verapamil, ramipril, gemfibrozil, hydrochlorothiazide, torsemide, rifampicin, and probenecid, illustrating changes in drug exposure caused by coadministration with empagliflozin.*

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Figure 2 (Jardiance 03)

A forest plot chart displaying the geometric mean ratio with 90% confidence intervals for various drugs including antidiabetic drugs, oral contraceptives, and other medications. The horizontal axis ranges from 50 to 150, showing comparative AUC and Cmax values for each listed drug such as Metformin, Glimepiride, Pioglitazone, and others.*

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Figure 3 (Jardiance 04)

A line graph depicting mean change from baseline in HbA1c (%) over 24 weeks for placebo, Empagliflozin 10 mg, and Empagliflozin 25 mg groups. The y-axis shows percent change in HbA1c, and the x-axis shows weeks from baseline. The graph compares treatment effects with error bars at week 24 indicating variability.*

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Figure 4 (Jardiance 05)

A line graph comparing the mean percentage change from baseline in HbA1c levels over 52 weeks between two treatment groups: Glimepiride plus Metformin (N=700) and Empagliflozin 25 mg plus Metformin (N=693). The x-axis represents weeks from baseline to 52, and the y-axis shows the percentage change. The graph includes error bars indicating variability at week 52.*

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Figure 5 (Jardiance 06)

A line chart comparing the percentage of patients with events over 48 months for placebo and all empagliflozin groups. The solid line represents placebo, and the dotted line represents empagliflozin, showing fewer events in the empagliflozin group. Below the x-axis is a table listing subjects at risk at various months for both groups.*

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Figure 6 (Jardiance 07)

A Kaplan-Meier curve comparing the percentage of patients with an event over 48 months between placebo and empagliflozin treatment groups. The x-axis represents the duration in months, and the y-axis shows the percentage of patients with events. The chart also includes a table of subjects at risk by month for both groups.*

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Figure 7 (Jardiance 08a)

A cumulative incidence curve chart comparing kidney function decline over approximately 810 days for patients receiving Empagliflozin 10 mg versus placebo, showing lower incidence rates with the Empagliflozin group. The chart includes patient risk counts at various time points and statistical data including hazard ratio and p-value.*

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Figure 8 (Jardiance 08b)

A Kaplan-Meier curve graph comparing mean number of events over days since randomization between placebo and Empagliflozin 10 mg groups. The graph shows two lines, one for placebo (N=1867) and one for Empagliflozin 10 mg (N=1863), with patient counts at risk noted below the X-axis. The chart includes hazard ratio (HR 0.70, 95% CI 0.58 to 0.85) and p-value (0.0003) for the comparison.*

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Figure 9 (Jardiance 08c)

A forest plot chart presenting hazard ratios comparing Empagliflozin 10 mg to placebo across various subgroups such as diabetes status, age, sex, race, BMI, eGFR, NYHA class, heart failure physiology, and baseline medication use. The plot illustrates confidence intervals and the direction of effect favoring either Empagliflozin or placebo.*

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Figure 10 (Jardiance 08d)

A line graph comparing estimated cumulative incidence percentage over days since randomization for Jardiance (Empagliflozin 10 mg) versus placebo. The chart includes patient risk counts over time and statistical values for hazard ratio and p-value for Empagliflozin 10 mg versus placebo.*

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Figure 11 (Jardiance 08e)

A Kaplan-Meier curve graph comparing the mean number of events over days since randomization in patients taking Empagliflozin 10 mg versus placebo. The graph shows two lines representing each group, with the Empagliflozin group demonstrating fewer events. Patient counts at risk are listed below the timeline. Hazard ratio (HR) with 95% confidence interval and p-value are noted for Empagliflozin versus placebo.*

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Figure 12 (Jardiance 08f)

A forest plot displaying the hazard ratio for Empagliflozin 10 mg compared to placebo across multiple subgroups. The plot includes categories such as Diabetes at baseline, Age, Sex, Race, BMI, eGFR at baseline, NYHA class, LVEF at baseline, NT-proBNP levels, and Baseline use of MRA, with corresponding event rates, hazard ratios, and 95% confidence intervals illustrated as horizontal lines and markers.*

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Figure 13 (Jardiance 08g)

A line chart comparing the estimated cumulative incidence function percentage over months since randomization for Empagliflozin 10 mg versus placebo in a clinical study. The chart shows two lines: one solid for placebo and one dashed for Empagliflozin 10 mg, with patient risk numbers at various time points below the x-axis. The chart includes a hazard ratio (HR) and confidence interval (CI) indicating statistical comparison between the groups.*

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Figure 14 (Jardiance 08h)

A forest plot displaying hazard ratios with 95% confidence intervals comparing Empagliflozin 10 mg versus placebo across patient subgroups. The plot includes categories such as diabetes status, baseline eGFR, baseline UACR, age, sex, race, history of renal disease, and RAS inhibitor use, indicating subgroup-specific event counts and hazard ratios for Empagliflozin effectiveness.*

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Qr Code (Jardiance 08i)

The image shows a carton box of Jardiance 10 mg film-coated tablets. The packaging indicates the active ingredient as empagliflozin. This oral prescription drug is labeled by Aphena Pharma Solutions - Tennessee, LLC and the product NDC is 71610-900. The package appears to be designed for retail pharmacy dispensing.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.