Mirabegron Tablet, Film Coated, Extended Release
Product Images NDC 69238-2860

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Mirabegron (NDC 69238-2860). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Amneal Pharmaceuticals Ny Llc, 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

Chem Structure (Mirabegron Extended Release Tablets 1)

Chemical structure of mirabegron, showing its molecular formula with rings, functional groups including hydroxyl, amine, and thiazole moieties.*

FDA Label Image

25mg 90ct Label (Mirabegron Extended Release Tablets 10)

Label for Mirabegron Extended-Release Tablets, 25 mg strength, for oral use. The label instructions state to swallow the tablet whole without cutting, crushing, or chewing. The packaging contains 90 tablets and indicates once-daily dosing. The labeler is Amneal Pharmaceuticals NY LLC, with manufacturing by MSN Laboratories Private Limited in India.*

FDA Label Image

50mg 90ct Label (Mirabegron Extended Release Tablets 11)

Label for Mirabegron Extended-Release Tablets 50 mg, oral film-coated extended-release tablets, packaged as 90 tablets. Instructions highlight swallowing the tablet whole without cutting, crushing, or chewing. Manufactured by MSN Laboratories Private Limited and distributed by Amneal Pharmaceuticals LLC. Includes storage instructions and dispensing requirements.*

FDA Label Image

Figure 1 (Mirabegron Extended Release Tablets 2)

A pharmacokinetic chart depicting mean changes in AUC and Cmax relative to mirabegron alone for various CYP3A/Pgp inhibitors and inducers (ketoconazole, rifampicin) and other drugs (solifenacin, tamsulosin, metformin), with corresponding dose adjustment recommendations on the right. The x-axis shows mean change values with 90% confidence intervals.*

FDA Label Image

Figure 2 (Mirabegron Extended Release Tablets 3)

A chart displaying fold changes in pharmacokinetic parameters (AUC and Cmax) of various CYP3A4 and CYP2D6 substrates and other drugs relative to substrate alone, along with dosing recommendations. The graph includes data points with 90% confidence intervals and categorizes drugs by enzyme substrate type, illustrating the mean change in exposure when coadministered with another agent.*

FDA Label Image

Figure 3 (Mirabegron Extended Release Tablets 4)

A line graph showing the mean change from baseline over 12 weeks for placebo and Mirabegron 50 mg tablets. The x-axis represents time in weeks (Baseline, 4, 8, 12), and the y-axis represents mean change from baseline. The graph includes error bars for each data point, comparing placebo (n=291) to Mirabegron 50 mg (n=293), with Mirabegron showing a greater decrease over time.*

FDA Label Image

Figure 4 (Mirabegron Extended Release Tablets 5)

Line graph showing mean change from baseline over 12 weeks comparing placebo and Mirabegron 50 mg groups. The y-axis indicates mean change from baseline, and the x-axis indicates time in weeks (baseline, 4, 8, 12). Data points with error bars are plotted for both groups, showing greater reduction in the Mirabegron 50 mg group across time points.*

FDA Label Image

Figure 5 (Mirabegron Extended Release Tablets 6)

A line graph comparing mean change from baseline over 12 weeks between placebo and mirabegron 50 mg groups. The x-axis represents time in weeks (baseline, 4, 8, and 12), and the y-axis shows mean change from baseline values. Data points with error bars indicate that mirabegron 50 mg shows a greater decrease over time compared to placebo.*

FDA Label Image

Figure 6 (Mirabegron Extended Release Tablets 7)

A line graph comparing the mean change from baseline over 12 weeks between placebo and mirabegron 50 mg groups. The x-axis shows time points in weeks (Baseline, 4, 8, 12) and the y-axis shows mean change values, with error bars indicating variability. Mirabegron 50 mg shows a greater decrease compared to placebo over time.*

FDA Label Image

Figure 7 (Mirabegron Extended Release Tablets 8)

A line graph showing mean change from baseline over 12 weeks for three groups: 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. Mirabegron treatment groups show greater decreases compared to placebo, with error bars representing variability for each data point.*

FDA Label Image

Figure 8 (Mirabegron Extended Release Tablets 9)

A line graph displaying mean change from baseline over 12 weeks in a clinical study comparing placebo, mirabegron 25 mg, and mirabegron 50 mg. The x-axis represents weeks (BL, 4, 8, 12), and the y-axis represents mean change from baseline. Data points include error bars. Mirabegron 25 mg and 50 mg groups show a similar trend distinct from placebo.*

* 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.