Synjardy Tablet
Product Images NDC 0597-0159

12 FDA label images from Boehringer Ingelheim Pharmaceuticals, Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Synjardy (NDC 0597-0159). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Boehringer Ingelheim Pharmaceuticals, Inc., 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

Chemical Structure (Synjardy 01)

Chemical Structure (Synjardy 01)
Chemical structure diagram of empagliflozin, the active ingredient in Synjardy tablets. The structure shows the molecular arrangement including hydroxyl groups, a chlorine atom on a benzene ring, and a dioxolane ring moiety.*
FDA Label Image

Chemical Structure (Synjardy 02)

Chemical Structure (Synjardy 02)
Chemical structure of metformin hydrochloride, one of the active ingredients in Synjardy tablets, showing the molecular formula representation including nitrogen and hydrogen groups and the hydrochloride component.*
FDA Label Image

Figure 1 (Synjardy 03)

Figure 1 (Synjardy 03)
A forest plot showing the geometric mean ratio with 90% confidence intervals for AUC and Cmax values of various antidiabetic drugs and other medications compared to empagliflozin alone. The drugs are listed with their dosages and frequency, with data points and confidence intervals indicating their relative changes in pharmacokinetic parameters.*
FDA Label Image

Figure 2 (Synjardy 04)

Figure 2 (Synjardy 04)
A chart showing geometric mean ratios with 90% confidence intervals for various drugs including antidiabetic drugs, oral contraceptives, and other medications. The y-axis lists drugs by name and dosage, while the x-axis displays a range from 50 to 150 percent, illustrating relative pharmacokinetic measures (AUC and Cmax) compared across multiple drug types.*
FDA Label Image

Figure 3 (Synjardy 05)

Figure 3 (Synjardy 05)
Line graph depicting mean percentage change from baseline in HbA1c levels over 52 weeks for two treatment groups: Glimepiride plus Metformin (N=700) and Empagliflozin 25 mg plus Metformin (N=693). The x-axis represents time in weeks, and the y-axis shows HbA1c percent change. The graph illustrates trends in glycemic control between the two therapies with data points at baseline, 4, 12, 28, 40, and 52 weeks, including mean treatment differences at week 52.*
FDA Label Image

Figure 4 (Synjardy 06)

Figure 4 (Synjardy 06)
A line graph showing the percentage of patients with an event over 48 months comparing Placebo and All Empagliflozin groups. The x-axis represents time in months, and the y-axis represents patients with event in percentage. The graph includes a risk table below indicating numbers of subjects at risk for both groups at multiple time points.*
FDA Label Image

Figure 5 (Synjardy 07)

Figure 5 (Synjardy 07)
A line chart comparing the percentage of patients with events over 48 months between placebo and all empagliflozin groups. The vertical axis shows patients with event (%) from 0 to 20%, and the horizontal axis shows time in months from 0 to 48. The chart includes a risk table under the x-axis with subject numbers for placebo and empagliflozin groups at various time points.*
FDA Label Image

Image (Synjardy 08)

FDA Label Image

Principal Display Panel (5 mg/500 mg Tablet Bottle Label)

Principal Display Panel (5 mg/500 mg Tablet Bottle Label)
Synjardy 5 mg/500 mg tablets packaging label showing empagliflozin and metformin hydrochloride as active ingredients. The label indicates it contains 60 oral tablets, dispensed by Boehringer Ingelheim Pharmaceuticals, Inc. and Lilly. The label includes storage instructions, dosage note to see package insert, barcode, and licensing details from Germany.*
FDA Label Image

Principal Display Panel (5 mg/1000 mg Tablet Bottle Label)

Principal Display Panel (5 mg/1000 mg Tablet Bottle Label)
Label for Synjardy 5 mg/1000 mg oral tablets containing empagliflozin and metformin hydrochloride. The label shows the brand and generic names, dosage strength, count of 60 tablets, and manufacturer information including Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company. Directions note to dispense with accompanying medication guide and storage instructions are included.*
FDA Label Image

Principal Display Panel (12.5 mg/500 mg Tablet Bottle Label)

Principal Display Panel (12.5 mg/500 mg Tablet Bottle Label)
Label for Synjardy 12.5 mg/500 mg tablets containing empagliflozin and metformin hydrochloride. The oral tablet packaging indicates a count of 60 tablets. The label includes storage instructions, distributor and manufacturer information for Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company, and notes that the product is made in Germany under license from BI International GmbH.*
FDA Label Image

Principal Display Panel (12.5 mg/1000 mg Tablet Bottle Label)

Principal Display Panel (12.5 mg/1000 mg Tablet Bottle Label)
Synjardy 12.5 mg/1000 mg oral tablet packaging label showing empagliflozin and metformin hydrochloride as active ingredients. The label includes storage instructions, manufacturer and distributor information for Boehringer Ingelheim Pharmaceuticals, Inc. and Lilly, and indicates a 60-tablet bottle made in Germany. The label also features branding logos and a barcode.*

* 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.