Mirabegron Tablet, Film Coated, Extended Release
Product Images NDC 71335-2807

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Mirabegron (NDC 71335-2807). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Bryant Ranch Prepack, 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 (Mirabegron)

Chemical structure diagram of mirabegron, showing its molecular arrangement including phenyl groups, hydroxyl, amine, amide, and thiazole functional groups.*

FDA Label Image

Fig 1 (3e871d38 8ab6 48fa 8c01 Fdbe8c65fd85 02)

Chart depicting pharmacokinetic fold change and 90% confidence intervals for AUC and Cmax of mirabegron when co-administered with CYP3A/Pgp inhibitors and inducers (ketoconazole, rifampicin) and other drugs (solifenacin, tamsulosin, metformin). The x-axis shows mean change relative to mirabegron alone, with corresponding dose adjustment recommendations indicating no dose adjustment needed for all listed drugs.*

FDA Label Image

Fig 2 (3e871d38 8ab6 48fa 8c01 Fdbe8c65fd85 03)

A pharmacokinetic chart showing the mean fold change and 90% confidence intervals for various CYP3A4, CYP2D6, and other substrates with fold changes in AUC and Cmax. The chart includes recommendations for dose adjustments, ranging from 'No dose adjustment' to 'Caution' or 'Starting dose adjustment', based on the mean change relative to substrate alone.*

FDA Label Image

Figure 3 (3e871d38 8ab6 48fa 8c01 Fdbe8c65fd85 04)

A line graph depicting mean change from baseline over 12 weeks, comparing placebo and mirabegron 50 mg groups. The x-axis shows time points at baseline (BL), 4, 8, and 12 weeks; 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 4 (3e871d38 8ab6 48fa 8c01 Fdbe8c65fd85 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 shows mean change from baseline, with values decreasing over time. Data points for placebo are circles with a solid line; for mirabegron 50 mg, squares with a dash-dot line.*

FDA Label Image

Figure 5 (3e871d38 8ab6 48fa 8c01 Fdbe8c65fd85 06)

Line graph showing mean change from baseline over weeks for placebo and mirabegron 50 mg groups. The x-axis represents time in weeks (baseline, 4, 8, 12) and the y-axis represents mean change from baseline. Data points for placebo (n=325) decrease less steeply compared to mirabegron 50 mg (n=312), indicated by a dashed line and solid line with square and circle markers respectively.*

FDA Label Image

Figure 6 (3e871d38 8ab6 48fa 8c01 Fdbe8c65fd85 07)

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, with values decreasing below zero. Data points include error bars for both placebo (circles) and mirabegron 50 mg (squares) groups, illustrating a greater decrease in the mirabegron group over time.*

FDA Label Image

Figure 7 (3e871d38 8ab6 48fa 8c01 Fdbe8c65fd85 08)

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. Placebo is marked with circles, mirabegron 25 mg with triangles, and mirabegron 50 mg with squares, each with error bars reflecting variability.*

FDA Label Image

Figure 8 (3e871d38 8ab6 48fa 8c01 Fdbe8c65fd85 09)

A line graph depicting mean change from baseline over 12 weeks for three groups: placebo (n=415), mirabegron 25 mg (n=410), and mirabegron 50 mg (n=426). The x-axis represents weeks (BL, 4, 8, 12) and the y-axis shows mean change from baseline ranging from 0.00 to -2.25. Error bars indicate variability at each data point for all groups.*

FDA Label Image

Label (Lbl713352807)

Label for Mirabegron Extended-Release Tablets 25 mg by Bryant Ranch Prepack. The label includes the NDC 71335-2807-1, indicates the package contains 30 tablets, and states the tablets are film-coated and extended-release. Manufactured by Lupin Limited, with storage instructions and dispensing warnings included.*

* 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.