Mirabegron Tablet, Film Coated, Extended Release
Product Images NDC 70518-4665

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Mirabegron (NDC 70518-4665). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Remedyrepack Inc., 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

Image (6e53669c 9083 47ad 9bde 3a936703073e 119 1)

MIRABEGRON 50 mg oral extended-release film-coated tablets in a white plastic bottle with a white child-resistant cap. The label includes the product name MIRABEGRON, strength 50 mg, dosage form as sustained-release tablets, a quantity of 100 tablets, and the labeler REMEDYREPACK INC. The bottle bears standard pharmaceutical labeling text and regulatory markings.*

FDA Label Image

Image (6e53669c 9083 47ad 9bde 3a936703073e 135 1)

MIRABEGRON 50 mg extended-release film-coated oral tablets packaging label. The label features the product name MIRABEGRON prominently, with a subtle clover leaf design in the background. It indicates a single dose strength of 50 mg and identifies REMEDYREPACK INC. as the labeler.*

FDA Label Image

Remedy_label (Remedy Label)

Label for Mirabegron 50 mg extended-release film-coated tablets in a bottle of 90 tablets. The label includes dosage form and administration warnings such as swallowing the tablet whole without cutting, crushing, or chewing. It lists the NDC number 70518-4665-00 and repackaging information by RemedyRepack Inc. in Indiana, PA.*

FDA Label Image

Structure (Mirabegron)

Chemical structure of mirabegron, the active ingredient in MIRABEGRON 50 mg extended-release film-coated tablets by Remedyrepack Inc. The structure displays its molecular framework with phenyl, amine, and heterocyclic functional groups depicted.*

FDA Label Image

Fig 1 (B26f08e4 Dfe4 4a0f B6b5 E9abb495e415 02)

A graph showing the pharmacokinetic fold change and 90% confidence intervals for various drugs relative to mirabegron alone, including CYP3A/Pgp inhibitors and inducers (ketoconazole, rifampicin) and other drugs (solifenacin, tamsulosin, metformin). The graph plots mean changes in AUC and Cmax, with accompanying dosing recommendations indicating no dose adjustments are needed.*

FDA Label Image

Fig 2 (B26f08e4 Dfe4 4a0f B6b5 E9abb495e415 03)

A bar chart showing mean pharmacokinetic fold change with 90% confidence intervals for various CYP3A4, CYP2D6, and other substrates after drug administration. The X-axis represents mean change relative to substrate alone, and the Y-axis lists the substrates with dosage details. Recommendations for dose adjustments or cautions are noted on the right side of the chart.*

FDA Label Image

Figure 3 (B26f08e4 Dfe4 4a0f B6b5 E9abb495e415 04)

Line graph displaying 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 (circles) and mirabegron 50 mg (squares) show decreasing values over time, with mirabegron exhibiting greater reduction, including error bars for variability.*

FDA Label Image

Figure 4 (B26f08e4 Dfe4 4a0f B6b5 E9abb495e415 05)

A line graph comparing mean change from baseline over 12 weeks between placebo and mirabegron 50 mg groups. The x-axis shows weeks (Baseline, 4, 8, 12) and the y-axis shows mean change from baseline. Data points for placebo are marked with circles, and for mirabegron 50 mg with squares, showing a greater decrease over time for mirabegron compared to placebo.*

FDA Label Image

Figure 5 (B26f08e4 Dfe4 4a0f B6b5 E9abb495e415 06)

A line chart comparing the mean change from baseline over 12 weeks between placebo and mirabegron 50 mg groups. The x-axis represents time in weeks (BL, 4, 8, 12), and the y-axis shows mean change from baseline. Data points with error bars indicate measurements for placebo (circles) and mirabegron 50 mg (squares), with mirabegron showing a greater decrease over time.*

FDA Label Image

Figure 6 (B26f08e4 Dfe4 4a0f B6b5 E9abb495e415 07)

A line chart depicting mean change from baseline on the vertical axis and weeks on the horizontal axis for placebo and mirabegron 50 mg groups. The chart compares treatment effects over 12 weeks, with placebo data represented by filled circles and mirabegron 50 mg by filled squares, including error bars around each point.*

FDA Label Image

Figure 7 (B26f08e4 Dfe4 4a0f B6b5 E9abb495e415 08)

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 time in weeks (BL, 4, 8, 12) and the y-axis shows the mean change from baseline. Each group is plotted with error bars indicating variability.*

FDA Label Image

Figure 8 (B26f08e4 Dfe4 4a0f B6b5 E9abb495e415 09)

A line graph depicting mean change from baseline over weeks 0, 4, 8, and 12 comparing placebo and mirabegron at 25 mg and 50 mg doses. The vertical axis represents mean change from baseline, and the horizontal axis shows time in weeks. Data points include error bars, with placebo, mirabegron 25 mg, and mirabegron 50 mg represented by circles, triangles, and squares respectively.*

* 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.