Synjardy Tablet, Extended Release
Product Images NDC 0597-0280

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 0597-0280). 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 the active ingredient in Synjardy XR, depicting the molecular arrangement of its components including hydroxyl groups, aromatic rings, and a chlorine atom.*
FDA Label Image

Chemical Structure (Synjardy 02)

Chemical Structure (Synjardy 02)
Chemical structure diagram of the active ingredient indicated in the product data, showing a molecular formula with nitrogen, carbon, hydrogen atoms, and a hydrochloride (HCl) component.*
FDA Label Image

Figure 1 (Synjardy 03)

Figure 1 (Synjardy 03)
A forest plot chart showing geometric mean ratios with 90% confidence intervals comparing the pharmacokinetic parameters AUC and Cmax for various antidiabetic drugs and other medications relative to empagliflozin alone. The horizontal axis represents change relative to empagliflozin alone, ranging from 50 to 200. Drugs listed include metformin, glimepiride, pioglitazone, sitagliptin, linagliptin, simvastatin, warfarin, verapamil, ramipril, gemfibrozil, hydrochlorothiazide, torsemide, rifampicin, and probenecid, with their corresponding dosages and dosing frequencies.*
FDA Label Image

Figure 2 (Synjardy 04)

Figure 2 (Synjardy 04)
A forest plot chart depicting the geometric mean ratio with 90% confidence intervals for various drugs including antidiabetic drugs, oral contraceptives, and others. The x-axis shows the ratio scale from 50 to 150, while the y-axis lists drugs like Metformin, Glimepiride, Pioglitazone, Sitagliptin, Linagliptin, Ethinylestradiol, Levonorgestrel, Simvastatin, R- and S-Warfarin, Ramipril, Digoxin, Hydrochlorothiazide, and Torsemide. Both AUC and Cmax values are shown for each drug.*
FDA Label Image

Figure 3 (Synjardy 05)

Figure 3 (Synjardy 05)
A line graph comparing the mean percentage change from baseline in HbA1c levels over 52 weeks between two treatments: Glimepiride plus Metformin (N=700) and Empagliflozin 25 mg plus Metformin (N=693). The graph shows HbA1c changes at baseline, week 4, 12, 28, 40, and 52, with error bars displayed at week 52.*
FDA Label Image

Figure 4 (Synjardy 06)

Figure 4 (Synjardy 06)
A Kaplan-Meier curve showing the percentage of patients with an event over 48 months, comparing placebo (solid line) and all empagliflozin treatments (dotted line). The x-axis represents months, and the y-axis represents the percentage of patients with events. Below the graph are counts of subjects at risk in each group at selected time points.*
FDA Label Image

Figure 5 (Synjardy 07)

Figure 5 (Synjardy 07)
A Kaplan-Meier curve showing the percentage of patients with an event over 48 months for placebo versus all empagliflozin groups. The graph includes a table of subject counts at risk for each treatment group over time. The percentage of patients with events increases more steeply for the placebo group compared to the empagliflozin group throughout the study period.*
FDA Label Image

Image (Synjardy 08)

FDA Label Image

Principal Display Panel (10 mg/1000 mg Tablet Bottle Label)

Principal Display Panel (10 mg/1000 mg Tablet Bottle Label)
Label for Synjardy XR 10 mg/1000 mg extended-release tablets containing empagliflozin and metformin hydrochloride. The label includes dosage strength, manufacturer information (Boehringer Ingelheim Pharmaceuticals, Inc. and Lilly), storage instructions, and a barcode. The package contains 30 tablets and states Rx only.*
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 XR 5 mg/1000 mg extended-release tablets, containing empagliflozin and metformin hydrochloride. The label indicates the product is manufactured by Boehringer Ingelheim Pharmaceuticals, Inc. and marketed with Lilly USA, LLC. The package contains 60 tablets with storage information and a barcode.*
FDA Label Image

Principal Display Panel (25 mg/1000 mg Tablet Bottle Label)

Principal Display Panel (25 mg/1000 mg Tablet Bottle Label)
Packaging label for Synjardy XR extended-release tablets containing 25 mg empagliflozin and 1000 mg metformin hydrochloride. The label indicates a quantity of 30 tablets and marks the product as prescription only. It includes storage instructions, manufacturer details (Boehringer Ingelheim Pharmaceuticals, Inc. and Lilly USA), and the NDC code 0597-0295-88.*
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)
Packaging label for Synjardy XR 12.5 mg/1000 mg extended-release tablets containing empagliflozin and metformin hydrochloride. The label shows the product name, strength, NDC 0597-0300-45, quantity of 60 tablets, and is marketed by Boehringer Ingelheim Pharmaceuticals, Inc. and Lilly USA, LLC. Storage and handling instructions are included on the label.*

* 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.