Mirabegron Tablet, Film Coated, Extended Release
Product Images NDC 71335-2809

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Mirabegron (NDC 71335-2809). 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 of mirabegron, the active ingredient in the MIRABEGRON 25 mg extended-release film-coated oral tablet by Bryant Ranch Prepack.*

FDA Label Image

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

A pharmacokinetic chart showing the mean change relative to mirabegron alone for CYP3A/Pgp inhibitors/inducers and other drugs. It includes data on AUC and Cmax fold changes with 90% confidence intervals for ketoconazole, rifampicin, solifenacin, tamsulosin, and metformin, along with dosing recommendations of no dose adjustment.*

FDA Label Image

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

A chart displaying fold change and 90% confidence intervals of pharmacokinetic parameters (AUC, Cmax) for various CYP3A4 and CYP2D6 substrates and other drugs relative to substrate alone. The x-axis shows mean change, and recommendations on dose adjustments accompany the results, which include drugs such as solifenacin, ethinylestradiol, desipramine, metoprolol, tamsulosin, digoxin, warfarin, and metformin.*

FDA Label Image

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

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, 12), and the y-axis shows mean change from baseline. Data points include error bars indicating variability. Mirabegron group shows a greater decrease over time compared to placebo.*

FDA Label Image

Figure 4 (3e871d38 8ab6 48fa 8c01 Fdbe8c65fd85 05)

A line graph showing mean change from baseline over 12 weeks for placebo and mirabegron 50 mg groups. The x-axis is labeled 'Week' with intervals BL (baseline), 4, 8, and 12. The y-axis is labeled 'Mean Change from Baseline'. Two lines are shown: a solid line with circular markers for placebo (n=480) and a dashed line with square markers for mirabegron 50 mg (n=473), both showing a decrease in mean values over time with mirabegron demonstrating a greater decline.*

FDA Label Image

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

A line graph depicting 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 values. Two lines with markers display data points and error bars for placebo and mirabegron groups.*

FDA Label Image

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

A line graph depicting mean change from baseline over a 12-week period for placebo and mirabegron 50 mg groups. The x-axis represents weeks (BL, 4, 8, 12) and the y-axis shows mean change from baseline. Placebo data are shown with circles and a solid line; mirabegron 50 mg data are shown with squares and a dashed line, both including error bars.*

FDA Label Image

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

A line graph depicting mean change from baseline over 12 weeks separated by placebo, mirabegron 25 mg, and mirabegron 50 mg treatment groups. The x-axis shows time points at baseline, week 4, week 8, and week 12. The y-axis displays the mean change from baseline values. Placebo group data is represented by circles with a solid line, mirabegron 25 mg group by triangles with a dashed line, and mirabegron 50 mg group by squares with a dash-dot line. The graph includes error bars for variability at each time point.*

FDA Label Image

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

A line graph showing mean change from baseline over weeks 0, 4, 8, and 12 for placebo, mirabegron 25 mg, and mirabegron 50 mg groups. The y-axis represents mean change from baseline, and the x-axis represents weeks. Data points include error bars. Mirabegron groups show greater mean change compared to placebo over time.*

FDA Label Image

Label (Lbl713352809)

Label for Mirabegron Extended-Release Tablets, 25 mg strength. The bottle contains 90 tablets. The product is repackaged by Bryant Ranch Prepack, Inc., Burbank, CA and manufactured by Lupin Limited. Prescription drug, oral route. Includes storage and dispensing instructions along with barcode and QR codes for additional information.*

* 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.