Mirabegron Tablet, Film Coated, Extended Release
Product Images NDC 73190-115

Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Mirabegron (NDC 73190-115). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Avkare, 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

Chem Structure (Mirabegron Extended Release Tablets 1)

Chemical structure of Mirabegron, showing the arrangement of its atoms and bonds, including hydroxyl, amine, aromatic rings, and a thiadiazole group as part of the molecule.*

FDA Label Image

Figure 1 (Mirabegron Extended Release Tablets 2)

A pharmacokinetic chart displaying the mean changes relative to mirabegron alone for various CYP3A/Pgp inhibitors and inducers, including ketoconazole, rifampicin, solifenacin, tamsulosin, and metformin. The chart plots fold changes with 90% confidence intervals for AUC and Cmax values, alongside dosage information and dosing recommendations indicating no dose adjustment required for mirabegron.*

FDA Label Image

Figure 2 (Mirabegron Extended Release Tablets 3)

A chart showing the mean fold change in pharmacokinetic parameters (AUC and Cmax) of various CYP3A4, CYP2D6 substrates, and other drugs when taken with Mirabegron. The graph includes data points and 90% confidence intervals, along with dosing recommendations such as no dose adjustment, caution, or starting dose adjustments based on the substrate.*

FDA Label Image

Figure 3 (Mirabegron Extended Release Tablets 4)

A line graph showing mean change from baseline over 12 weeks comparing placebo and Mirabegron 50 mg. The x-axis represents time in weeks (BL, 4, 8, 12), and the y-axis represents mean change from baseline, with values decreasing over time. Placebo and Mirabegron 50 mg groups show a downward trend, with Mirabegron demonstrating a greater decrease than placebo.*

FDA Label Image

Figure 4 (Mirabegron Extended Release Tablets 5)

A line graph showing mean change from baseline over a 12-week period comparing placebo and mirabegron 50 mg. The x-axis represents weeks (baseline, 4, 8, and 12), and the y-axis represents mean change values. Data points indicate measurements with error bars for both treatment groups, demonstrating a greater mean change with mirabegron 50 mg compared to placebo over time.*

FDA Label Image

Figure 5 (Mirabegron Extended Release Tablets 6)

A line graph comparing the mean change from baseline over 12 weeks between placebo and mirabegron 50 mg groups. The x-axis represents weeks (BL, 4, 8, 12), and the y-axis shows mean change from baseline. Two lines indicate data for placebo (n=325) and mirabegron 50 mg (n=312), with mirabegron showing a greater decrease over time.*

FDA Label Image

Figure 6 (Mirabegron Extended Release Tablets 7)

A line graph comparing mean change from baseline over weeks between placebo and mirabegron 50 mg groups. The x-axis represents weeks (baseline, 4, 8, 12), and the y-axis shows mean change from baseline, with values decreasing over time. Data points include error bars indicating variability.*

FDA Label Image

Figure 7 (Mirabegron Extended Release Tablets 8)

A line graph depicting mean change from baseline over 12 weeks for placebo, Mirabegron 25 mg, 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 from 0 to -2. The graph includes error bars for each data point and differentiates groups by distinct markers and line styles.*

FDA Label Image

Figure 8 (Mirabegron Extended Release Tablets 9)

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 time in weeks (BL, 4, 8, 12), and the y-axis shows mean change from baseline with error bars. The graph compares treatment effect trends between the three groups.*

FDA Label Image

1 (How Supplied)

A table displaying physical and packaging details for Mirabegron extended-release tablets in 25 mg and 50 mg strengths. The 25 mg tablets are oval and brown with branding "25, M," while the 50 mg tablets are oval and yellow with branding "50, M." The table also lists corresponding NDC codes for bottles containing 30 and 90 tablets in each strength.*

FDA Label Image

1 (115 30)

Label for Mirabegron Extended-Release Tablets, 25 mg strength, oral extended-release film-coated tablets. The label states a 30-count package size and includes directions to swallow whole without cutting, crushing, or chewing. Manufactured for AvKARE, Pulaski, TN, with storage instructions and a barcode visible.*

FDA Label Image

1 (115 90)

Label for Mirabegron Extended-Release Tablets, 25 mg strength, oral dosage form, film coated and extended release. The label shows a bottle count of 90 tablets, with instructions to swallow whole and not to cut, crush, or chew. Manufactured for AvKARE, Pulaski, TN. Includes storage instructions and barcode.*

FDA Label Image

1 (116 30)

Label for Mirabegron Extended-Release Tablets 50 mg, oral film-coated tablets, manufactured by AvKARE. The label indicates the product contains 30 tablets with instructions to swallow whole without cutting, crushing, or chewing. It includes storage information and pharmacist dispensing requirements.*

FDA Label Image

1 (116 90)

Label for Mirabegron Extended-Release Tablets 50 mg, once-daily oral film-coated tablets. The package contains 90 tablets and is manufactured for AvKARE. The label includes dosing instructions and storage conditions, emphasizing swallowing tablets whole and pharmacist dispensing instructions.*

* 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.