Mirabegron Tablet, Extended Release
Product Images NDC 70518-4304

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Mirabegron (NDC 70518-4304). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Remedyrepack 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

Structure (77f4fa2d 8c1c 4906 880f B6c1c10f2655 01)

Chemical structure of mirabegron showing its molecular framework with benzene rings, hydroxyl group, amine groups, and a thiadiazole ring.*

FDA Label Image

Figure 1 (77f4fa2d 8c1c 4906 880f B6c1c10f2655 02)

A chart illustrating the pharmacokinetic effects of various CYP3A/Pgp inhibitors and inducers, as well as other drugs, on mirabegron. It shows fold changes with 90% confidence intervals for AUC and Cmax, comparing co-administration relative to mirabegron alone. Recommendations noted include no dose adjustments for listed drugs ranging from ketoconazole to metformin.*

FDA Label Image

Figure 2 (77f4fa2d 8c1c 4906 880f B6c1c10f2655 03)

A chart displaying pharmacokinetic (PK) fold changes and 90% confidence intervals for various CYP3A4 and CYP2D6 substrates and other drugs, including solifenacin, ethinylestradiol, levonorgestrel, desipramine, metoprolol, tamsulosin, digoxin, warfarin, and metformin. The x-axis shows mean change relative to substrate alone, with recommendations for dose adjustments listed for each drug.*

FDA Label Image

Figure 3 (77f4fa2d 8c1c 4906 880f B6c1c10f2655 04)

Line graph showing mean change from baseline over 12 weeks comparing placebo and Mirabegron 50 mg. The x-axis represents time in weeks (baseline, 4, 8, and 12), and the y-axis represents mean change from baseline. Data points with error bars illustrate that Mirabegron 50 mg (square markers) shows a greater mean decrease over time compared to placebo (circle markers).*

FDA Label Image

Figure 4 (77f4fa2d 8c1c 4906 880f B6c1c10f2655 05)

A line graph comparing the mean change from baseline over 12 weeks between placebo and Mirabegron 50 mg groups. The x-axis represents weeks (BL, 4, 8, 12), and the y-axis shows mean change from baseline. Two lines plot placebo (n=480) and Mirabegron 50 mg (n=473), with Mirabegron showing a greater mean change at each time point.*

FDA Label Image

Figure 5 (77f4fa2d 8c1c 4906 880f B6c1c10f2655 06)

A line graph comparing the mean change from baseline over 12 weeks for placebo and Mirabegron 50 mg groups. The x-axis represents weeks (baseline, 4, 8, 12), and the y-axis shows mean change from baseline. Data points for placebo and Mirabegron 50 mg include error bars indicating variability.*

FDA Label Image

Figure 6 (77f4fa2d 8c1c 4906 880f B6c1c10f2655 07)

A line graph showing mean change from baseline over weeks 4, 8, and 12 for placebo and mirabegron 50 mg groups. The y-axis represents mean change from baseline, and the x-axis represents time in weeks. The graph includes error bars and distinguishes two groups: placebo (circle markers) and mirabegron 50 mg (square markers).*

FDA Label Image

Figure 7 (77f4fa2d 8c1c 4906 880f B6c1c10f2655 08)

A line graph depicting mean change from baseline over weeks for placebo, mirabegron 25 mg, and mirabegron 50 mg treatment groups. The X-axis represents time points at baseline, week 4, week 8, and week 12. The Y-axis shows mean change from baseline values, ranging from 0 to -2. Data points for each group include error bars indicating variability.*

FDA Label Image

Figure 8 (77f4fa2d 8c1c 4906 880f B6c1c10f2655 09)

A line graph showing the mean change from baseline over weeks 4, 8, and 12 for three groups: placebo, mirabegron 25 mg, and mirabegron 50 mg. The vertical axis represents mean change from baseline, the horizontal axis shows weeks. Mirabegron groups demonstrate a greater decrease compared to placebo over time, with error bars indicating variability.*

FDA Label Image

Mm1 (Mirabegron 50mg 70518 4304 00)

Mirabegron 50 mg extended-release oral tablets in a quantity of 90 tablets. The label indicates the product is prescription only (Rx), with a barcode and QR code present. Manufacturer information lists Zydus Pharm, Pennington, NJ, while repackaging is done by RemedyRepack Inc., Indiana, PA. The label includes a warning to swallow tablets whole and storage instructions.*

* 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.