Mirabegron Tablet, Film Coated, Extended Release
Product Images NDC 71335-2810

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Mirabegron (NDC 71335-2810). 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, depicting its molecular arrangement including phenyl, hydroxyl, amine, and thiazole functional groups. This structural formula illustrates the specific bonding and composition of the active ingredient mirabegron.*

FDA Label Image

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

A pharmacokinetic chart showing the fold change and 90% confidence interval of AUC and Cmax for CYP3A/Pgp inhibitors and inducers (Ketoconazole and Rifampicin), and other drugs (Solifenacin, Tamsulosin, Metformin) relative to mirabegron alone. The graph indicates no dose adjustment recommendations for these drugs when used with mirabegron.*

FDA Label Image

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

A pharmacokinetic chart illustrating the fold change and 90% confidence intervals for various CYP3A4 and CYP2D6 substrates plus other drugs when co-administered, with recommendations for dose adjustments. The x-axis shows mean change relative to substrate alone, with drug names and dosages listed on the y-axis, separated into CYP3A4 substrates, CYP2D6 substrates, and other drugs.*

FDA Label Image

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

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 from baseline. Two lines with markers show decreasing values over time, with mirabegron 50 mg (squares) showing larger negative changes than placebo (circles). Error bars indicate 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. Data points for placebo are circles connected by a solid line, and mirabegron 50 mg are squares connected by a dashed line, both with error bars.*

FDA Label Image

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

A line graph showing the mean change from baseline over 12 weeks for mirabegron 50 mg and placebo groups. The x-axis represents time in weeks (BL, 4, 8, 12), and the y-axis shows mean change from baseline with values ranging from 0 to -2. Two lines represent placebo and mirabegron 50 mg groups with data points and error bars indicating variability.*

FDA Label Image

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

A line graph depicting the mean change from baseline over 12 weeks for two groups: placebo (circle markers) and mirabegron 50 mg (square markers). The x-axis shows time points at baseline, week 4, week 8, and week 12, while the y-axis represents the mean change from baseline values. Both groups show a decrease over time, with mirabegron 50 mg exhibiting a greater mean change compared to placebo. Error bars indicate variability at each point.*

FDA Label Image

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

This line graph depicts the mean change from baseline over 12 weeks across three groups: placebo, mirabegron 25 mg, and mirabegron 50 mg. The vertical axis measures mean change from baseline, and the horizontal axis represents time in weeks (BL, 4, 8, 12). Data points for each group include error bars, illustrating variability.*

FDA Label Image

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

A line graph showing mean change from baseline over 12 weeks for placebo and mirabegron 25 mg and 50 mg groups. The X-axis represents weeks (baseline, 4, 8, and 12), and the Y-axis shows mean change from baseline. Data points include error bars for variability. Lines show decreasing mean changes over time for each group, with mirabegron 25 mg and 50 mg groups showing more reduction than placebo.*

FDA Label Image

Label (Lbl713352810)

Label for Mirabegron Extended-Release Tablets, 50 mg, oral film-coated tablet. The label indicates a package size of 90 tablets, repackaged by Bryant Ranch Prepack, Inc., Burbank, CA, and manufactured by Lupin Limited. The label includes dosage instructions and storage conditions, plus barcodes and QR codes for package inserts.*

* 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.