Mirabegron Tablet, Film Coated, Extended Release
Product Images NDC 68180-152

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Mirabegron (NDC 68180-152). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Lupin Pharmaceuticals, 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

Structure (Mirabegron)

Chemical structure of mirabegron, the active ingredient in MIRABEGRON extended-release film-coated tablets by Lupin Pharmaceuticals, Inc. The structure shows the molecular arrangement including aromatic rings, hydroxyl, amine, and thiadiazole groups.*

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Fig 1 (Df9595b1 E4de 4e5f A76a 6d89e139303d 02)

A pharmacokinetic chart showing the fold change and 90% confidence intervals for AUC and Cmax of mirabegron when coadministered with CYP3A/Pgp inhibitors or inducers and other drugs such as ketoconazole, rifampicin, solifenacin, tamsulosin, and metformin. The graph includes dosing information and indicates that no dose adjustment is recommended for these combinations.*

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Fig 2 (Df9595b1 E4de 4e5f A76a 6d89e139303d 03)

A chart showing the mean change relative to substrate alone for various CYP3A4 and CYP2D6 substrates and other drugs. It compares PK parameters AUC and Cmax, showing fold changes with 90% confidence intervals, alongside dosing recommendations such as no dose adjustment or caution for specific drugs.*

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Figure 3 (Df9595b1 E4de 4e5f A76a 6d89e139303d 04)

A line graph depicting mean change from baseline over 12 weeks for placebo and mirabegron 50 mg. The x-axis shows weeks (BL, 4, 8, 12), and the y-axis shows mean change from baseline values from 0 to -2.0. Placebo data points are marked with circles and a solid line, while mirabegron 50 mg data points are squares with a dashed line, indicating a greater mean decrease for mirabegron over time.*

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Figure 4 (Df9595b1 E4de 4e5f A76a 6d89e139303d 05)

A line graph showing mean change from baseline over 12 weeks comparing placebo and mirabegron 50 mg groups. The x-axis represents weeks (BL, 4, 8, 12) and the y-axis shows mean change from baseline. Data points for placebo and mirabegron 50 mg are plotted with error bars, indicating a greater mean change in the mirabegron group throughout the study period.*

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Figure 5 (Df9595b1 E4de 4e5f A76a 6d89e139303d 06)

A line graph showing 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 indicates mean change from baseline. Two lines depict data points with error bars for placebo and mirabegron 50 mg groups.*

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Figure 6 (Df9595b1 E4de 4e5f A76a 6d89e139303d 07)

A line graph showing mean change from baseline over time (weeks 0, 4, 8, 12) comparing placebo and mirabegron 50 mg treatment groups. The y-axis represents mean change from baseline. Mirabegron 50 mg data points are represented by squares connected with a dashed line, and placebo data points by circles with a solid line. Error bars indicate variability for each time point.*

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Figure 7 (Df9595b1 E4de 4e5f A76a 6d89e139303d 08)

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 (baseline, 4, 8, 12) and the y-axis represents mean change from baseline. Data points for mirabegron 25 mg and 50 mg show a greater decrease compared to placebo.*

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Figure 8 (Df9595b1 E4de 4e5f A76a 6d89e139303d 09)

A line graph illustrating the mean change from baseline over 12 weeks for placebo and mirabegron 25 mg and 50 mg doses. The x-axis represents weeks (Baseline, 4, 8, 12), and the y-axis shows mean change from baseline, decreasing over time. Lines with markers compare placebo and two mirabegron dose groups across the study period.*

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Bottle Label (25 mg)

The label for Mirabegron Extended-Release Tablets, 25 mg, from Lupin Pharmaceuticals, Inc. It includes dosage form details as film-coated, extended-release oral tablets, with a 30-count package. The label specifies swallowing the tablet whole and storing at controlled room temperature. Manufacturer information includes Lupin Pharmaceuticals in Baltimore, MD, and Lupin Limited in Nagpur, India.*

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Image 11 (Df9595b1 E4de 4e5f A76a 6d89e139303d 11)

Mirabegron Extended-Release Tablets 25 mg film-coated tablets packaging label by Lupin Pharmaceuticals, Inc. The label shows a 30-tablet bottle with directions to swallow whole, not to cut, crush, or chew. It includes storage instructions, the NDC number 68180-151-06, and manufacturer details from Lupin Pharmaceuticals, Inc. and Lupin Limited, India.*

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Bottle Label (50 mg)

Label for Mirabegron Extended-Release Tablets 50 mg, oral, film-coated, extended-release tablets available in a 30-count package. The label states once-daily dosing, swallowing tablets whole, and the product is manufactured by Lupin Pharmaceuticals, Inc. with distribution details and storage instructions included.*

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Image 13 (Df9595b1 E4de 4e5f A76a 6d89e139303d 13)

Packaging label for Mirabegron Extended-Release Tablets, 50 mg strength, manufactured by Lupin Pharmaceuticals, Inc. Label indicates 30 film-coated, extended-release oral tablets per container. Instructions include swallowing the tablet whole and storing at controlled room temperature.*

* 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.