Mirabegron Tablet, Extended Release
Product Images NDC 70710-1159

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Mirabegron (NDC 70710-1159). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Zydus Pharmaceuticals (usa) 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, the active ingredient in Mirabegron extended release tablets. The structure shows the molecular connectivity and functional groups characteristic of mirabegron.*

FDA Label Image

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

A chart illustrating the pharmacokinetic (PK) fold changes and 90% confidence intervals (CI) of various CYP3A/P-gp inhibitors/inducers and other drugs relative to mirabegron alone, with measurements of AUC and Cmax. The chart includes drugs such as Ketoconazole, Rifampicin, Solifenacin, Tamsulosin, and Metformin, showing their fold change values along with corresponding recommendations on dose adjustment, mostly indicating no dose adjustment is needed.*

FDA Label Image

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

A pharmacokinetic chart illustrating fold changes and 90% confidence intervals in AUC and Cmax for various CYP3A4 and CYP2D6 substrates and other drugs, with corresponding dosing recommendations such as no dose adjustment or caution. The x-axis represents mean change relative to substrate alone, ranging from 0.0 to 4.0.*

FDA Label Image

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

A line graph depicting the mean change from baseline over 12 weeks comparing placebo and mirabegron 50 mg. The x-axis represents weeks (baseline, 4, 8, 12), and the y-axis shows mean change from baseline, with mirabegron showing a greater decrease compared to placebo. Data points include error bars for both groups.*

FDA Label Image

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

A line graph showing the mean change from baseline over 12 weeks comparing placebo and mirabegron 50 mg treatment groups. The x-axis represents time in weeks (BL, 4, 8, 12), and the y-axis represents mean change from baseline. Data points for placebo (circles) and mirabegron 50 mg (squares) show a greater mean decrease over time for mirabegron with error bars indicating variability.*

FDA Label Image

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

A line graph showing mean change from baseline over 12 weeks for placebo and Mirabegron 50 mg groups. The y-axis represents mean change from baseline, ranging approximately from 0 to -2.0, and the x-axis shows time points at baseline, week 4, week 8, and week 12. Mirabegron 50 mg group shows a greater decrease from baseline compared to placebo, with error bars indicating variability at 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 50 mg Mirabegron treatments. The y-axis shows mean change from baseline, and the x-axis represents time in weeks (baseline, 4, 8, 12 weeks). Placebo data points use circles, Mirabegron 50 mg data points use squares, both with error bars.*

FDA Label Image

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

A line graph depicting mean change from baseline over 12 weeks for three groups: placebo (n=262), mirabegron 25 mg (n=254), and mirabegron 50 mg (n=257). The x-axis shows time points at baseline, week 4, week 8, and week 12. The y-axis quantifies mean change. Data points include error bars indicating variability.*

FDA Label Image

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

A line graph showing mean change from baseline over 12 weeks for placebo, mirabegron 25 mg, and mirabegron 50 mg groups. The x-axis represents weeks (BL, 4, 8, 12) and the y-axis shows mean change from baseline values. Data points include error bars indicating variability for each group at each time point.*

FDA Label Image

Mirabegron Extended-release Tablets, 25mg (77f4fa2d 8c1c 4906 880f B6c1c10f2655 10)

Mirabegron Extended-Release Tablets 25 mg oral tablets packaging label. The label indicates once-daily use and contains 30 tablets. It includes storage instructions, dosage information, and manufacturing details by Zydus Lifesciences Ltd., distributed by Zydus Pharmaceuticals (USA) Inc. The label features a barcode and the NDC number 70710-1159-3.*

FDA Label Image

Mirabegron Extended-release Tablets, 50mg (77f4fa2d 8c1c 4906 880f B6c1c10f2655 11)

Label for Mirabegron Extended-Release Tablets 50 mg oral tablets by Zydus Pharmaceuticals (USA) Inc. The label indicates a package of 30 tablets, once-daily use, and directs to swallow the tablet whole without cutting, crushing, or chewing. It includes storage instructions, safety warnings, and manufacturer and distributor details.*

* 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.