Mirabegron Tablet, Extended Release
Product Images NDC 70518-4631

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Mirabegron (NDC 70518-4631). 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 arrangement with various rings and functional groups.*

FDA Label Image

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

A chart showing the mean change in pharmacokinetic parameters (AUC and Cmax) relative to mirabegron alone when coadministered with CYP3A/Pgp inhibitors or inducers and other drugs. It includes data for ketoconazole, rifampicin, solifenacin, tamsulosin, and metformin, with recommendations on dose adjustments. Error bars represent 90% confidence intervals.*

FDA Label Image

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

A forest plot chart showing the mean change relative to substrate alone for various CYP3A4, CYP2D6, and other substrates after administration with Mirabegron. The chart presents pharmacokinetic parameters (AUC and Cmax), fold changes with 90% confidence intervals, and dosing recommendations such as no dose adjustment or caution for each substrate.*

FDA Label Image

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

A line graph showing mean change from baseline over 12 weeks comparing placebo and mirabegron 50 mg groups. The x-axis represents weeks (BL, 4, 8, 12), and the y-axis represents the mean change from baseline. Data points with error bars illustrate trends for both groups, with mirabegron showing greater reduction over time.*

FDA Label Image

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

A line graph showing mean change from baseline over 12 weeks comparing placebo and mirabegron 50 mg. The x-axis represents weeks (BL, 4, 8, 12) and the y-axis represents mean change from baseline. Placebo is depicted with circles and a solid line, mirabegron 50 mg with squares and a dashed line, showing greater mean change with mirabegron across time points.*

FDA Label Image

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

A line graph depicting mean change from baseline over 12 weeks, comparing placebo (circles) and mirabegron 50 mg (squares) groups. The vertical axis shows mean change from baseline, and the horizontal axis indicates weeks at baseline, 4, 8, and 12. Error bars represent variability for each time point.*

FDA Label Image

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

A line graph depicting mean change from baseline over 12 weeks comparing placebo and mirabegron 50 mg groups. The x-axis shows time in weeks (BL, 4, 8, 12), while the y-axis shows mean change from baseline values. Two lines represent the placebo group (n=433) and mirabegron 50 mg group (n=425), with mirabegron showing a greater decline in mean change over time.*

FDA Label Image

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

A line graph showing mean change from baseline over 12 weeks for placebo, mirabegron 25 mg, and mirabegron 50 mg. The x-axis represents weeks (BL, 4, 8, 12), and the y-axis shows mean change values. Different symbols denote treatment groups with 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 12 weeks for placebo and two doses of Mirabegron (25 mg and 50 mg). The x-axis represents time in weeks (baseline, 4, 8, and 12), and the y-axis shows the mean change from baseline. Data points include placebo (circle), Mirabegron 25 mg (triangle), and Mirabegron 50 mg (square) with error bars.*

FDA Label Image

Mm1 (Mirabegron 25mg 70518 4631 00)

Mirabegron 25 mg extended-release tablets, oral route, in a box containing 50 tablets. The label shows NDC number 70518-4631-00 and notes repackaging by RemedyRepack Inc., Indiana, PA. Manufacturer is Zydus Pharmaceuticals, Pennington, NJ. Storage conditions and usual dosage directions refer to the package insert.*

FDA Label Image

Remedy_label (Remedy Label)

Mirabegron 25 mg extended-release tablet packaging label showing quantity of 1 tablet. The label includes NDC 70518-4631-01, states it is repackaged by RemedyRepack Inc. in Indiana, PA. Manufacturer is Zydus Pharmaceuticals, Pennington, NJ. Storage instructions and a QR code are visible.*

* 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.