Mirabegron Tablet, Extended Release
Product Images NDC 70771-1753

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Mirabegron (NDC 70771-1753). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Zydus Lifesciences Limited, 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 (9dd396b5 4841 483a B63b 63a0e3cea1ae 01)

Chemical structure of Mirabegron, showing its molecular components and arrangement, including aromatic rings, hydroxyl group, amine groups, and heterocyclic thiazole ring.*

FDA Label Image

Figure 1 (9dd396b5 4841 483a B63b 63a0e3cea1ae 02)

A forest plot graph showing pharmacokinetic fold changes and 90% confidence intervals for CYP3A/Pgp inhibitors and inducers, as well as other drugs, relative to mirabegron alone. The x-axis indicates mean change in AUC and Cmax values, with recommendations listed for no dose adjustments for ketoconazole, rifampicin, solifenacin, tamsulosin, and metformin.*

FDA Label Image

Figure 2 (9dd396b5 4841 483a B63b 63a0e3cea1ae 03)

A pharmacokinetic chart showing mean fold changes and 90% confidence intervals in AUC and Cmax for various CYP3A4 substrates, CYP2D6 substrates, and other drugs when co-administered with Mirabegron. The chart includes dose adjustment recommendations, indicating no dose adjustment for some drugs and caution or dose adjustment guidance for others.*

FDA Label Image

Figure 3 (9dd396b5 4841 483a B63b 63a0e3cea1ae 04)

A line graph showing mean change from baseline over 12 weeks, comparing placebo and Mirabegron 50 mg groups. The x-axis represents time points (baseline, week 4, week 8, week 12), and the y-axis shows mean change from baseline. Data points with error bars illustrate decreases over time, with Mirabegron 50 mg showing a greater decrease than placebo.*

FDA Label Image

Figure 4 (9dd396b5 4841 483a B63b 63a0e3cea1ae 05)

A line graph showing the mean change from baseline over 12 weeks, comparing placebo and Mirabegron 50 mg. The x-axis represents time in weeks (BL, 4, 8, 12), and the y-axis shows mean change from baseline. Data points with error bars demonstrate that Mirabegron 50 mg results in a greater decrease compared to placebo throughout the period.*

FDA Label Image

Figure 5 (9dd396b5 4841 483a B63b 63a0e3cea1ae 06)

A line graph comparing mean change from baseline over 12 weeks between placebo and Mirabegron 50 mg groups. The x-axis shows time points at baseline (BL), 4, 8, and 12 weeks, while the y-axis shows mean change from baseline values. The Mirabegron 50 mg group shows a greater decrease compared to placebo at each time point, with data points represented by squares for Mirabegron and circles for placebo.*

FDA Label Image

Figure 6 (9dd396b5 4841 483a B63b 63a0e3cea1ae 07)

Line graph showing mean change from baseline over 12 weeks comparing placebo and mirabegron 50 mg tablet. The x-axis represents weeks (baseline, 4, 8, 12), and the y-axis shows mean change from baseline. The graph includes error bars and indicates greater reduction for mirabegron 50 mg than placebo over time.*

FDA Label Image

Figure 7 (9dd396b5 4841 483a B63b 63a0e3cea1ae 08)

A line graph showing mean change from baseline over 12 weeks in a study comparing placebo, mirabegron 25 mg, and mirabegron 50 mg. The x-axis represents weeks (BL, 4, 8, 12), and the y-axis shows mean change from baseline. Data points for placebo, mirabegron 25 mg, and mirabegron 50 mg are marked by circles, triangles, and squares, respectively, with error bars indicating variability.*

FDA Label Image

Figure 8 (9dd396b5 4841 483a B63b 63a0e3cea1ae 09)

Line chart showing mean change from baseline over 12 weeks for placebo, mirabegron 25 mg, and mirabegron 50 mg groups. The x-axis represents weeks (baseline, 4, 8, and 12), and the y-axis shows mean change from baseline. Data points indicate a decline over time in all groups, with mirabegron groups showing a greater change than placebo.*

FDA Label Image

Mirabegron Extended-release Tablets, 25mg (9dd396b5 4841 483a B63b 63a0e3cea1ae 10)

Label for Mirabegron Extended-Release Tablets, 25 mg strength, oral tablets for once-daily use. The product is manufactured by Cadila Healthcare Ltd., Matoda, Ahmedabad, India, and is distributed under the ZyGenerics brand. The package contains 100 tablets and includes directions to swallow whole without cutting or crushing.*

FDA Label Image

Mirabegron Extended-release Tablets, 50mg (9dd396b5 4841 483a B63b 63a0e3cea1ae 11)

Label for Mirabegron 50 mg extended-release tablets by Zygenerics, supplied in a bottle of 100 tablets. The label states the product is for once-daily oral use, with instructions to swallow the tablet whole without cutting, crushing, or chewing. Manufactured by Cadila Healthcare Ltd., Matoda, Ahmedabad, India.*

* 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.