Mirabegron Tablet, Film Coated, Extended Release
Product Images NDC 71335-2808

View Photos of Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Mirabegron (NDC 71335-2808). 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)

Structure (Mirabegron)
Chemical structure of mirabegron, the active ingredient in MIRABEGRON 50 mg extended-release tablets by Bryant Ranch Prepack.*
FDA Label Image

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

Fig 1 (3e871d38 8ab6 48fa 8c01 Fdbe8c65fd85 02)
A chart displaying pharmacokinetic (PK) fold changes and 90% confidence intervals (CI) in AUC and Cmax for various CYP3A/Pgp inhibitors and inducers as well as other drugs relative to mirabegron alone. The chart includes ketoconazole, rifampicin, solifenacin, tamsulosin, and metformin, with recommendations all indicating no dose adjustment. The x-axis shows mean change relative to mirabegron alone from 0.0 to 4.0.*
FDA Label Image

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

Fig 2 (3e871d38 8ab6 48fa 8c01 Fdbe8c65fd85 03)
A chart showing the mean fold change in pharmacokinetic parameters (AUC and Cmax) with 90% confidence intervals for various CYP3A4 and CYP2D6 substrates as well as other drugs when taken alone versus with an unspecified interaction. The chart includes recommendations regarding dose adjustments for each drug listed, such as no dose adjustment, caution, or specific starting dose changes.*
FDA Label Image

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

Figure 3 (3e871d38 8ab6 48fa 8c01 Fdbe8c65fd85 04)
A line graph showing mean change from baseline over weeks 0, 4, 8, and 12 comparing placebo and mirabegron 50 mg groups. The y-axis represents mean change from baseline, and the x-axis represents weeks. Mirabegron 50 mg shows a greater decrease from baseline compared to placebo across the time points, with error bars indicating variability.*
FDA Label Image

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

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 is labeled by weeks (Baseline, 4, 8, 12), and the y-axis shows mean change from baseline. Placebo is represented by circles with a solid line; mirabegron 50 mg is represented by squares with a dashed line, showing greater mean change from baseline over time.*
FDA Label Image

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

Figure 5 (3e871d38 8ab6 48fa 8c01 Fdbe8c65fd85 06)
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, ranging from 0 to -2. Mirabegron 50 mg data points decline more steeply than placebo, indicating a greater mean change over time. Error bars are shown for each data point.*
FDA Label Image

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

Figure 6 (3e871d38 8ab6 48fa 8c01 Fdbe8c65fd85 07)
A line graph depicting the mean change from baseline over 12 weeks for placebo and mirabegron 50 mg groups. The x-axis shows time in weeks (BL, 4, 8, 12), and the y-axis shows mean change from baseline. Data points include error bars. The placebo group is represented by circles and a solid line, while the mirabegron 50 mg group is shown with squares and a dashed line.*
FDA Label Image

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

Figure 7 (3e871d38 8ab6 48fa 8c01 Fdbe8c65fd85 08)
A line graph showing the 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 the mean change from baseline, with values decreasing below zero. Data points for placebo, mirabegron 25 mg, and 50 mg are shown with error bars, indicating changes over time for each group.*
FDA Label Image

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

Figure 8 (3e871d38 8ab6 48fa 8c01 Fdbe8c65fd85 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 the mean change from baseline ranging from 0 to -2.25. Data points include error bars and distinct markers for each group.*
FDA Label Image

Label (Lbl713352808)

Label (Lbl713352808)
Label for Mirabegron Extended-Release Tablets 50 mg, a human prescription drug in film-coated tablet form. The label shows the product name, strength, dosage form, quantity of 30 tablets, and manufacturer Lupin Limited. It includes dispensing instructions, storage conditions, and barcode with NDC 71335-2808-1. The labeler is Bryant Ranch Prepack.*

* 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.