Structure (Mirabegron)
Chemical structure of mirabegron, the active ingredient in MIRABEGRON extended-release film-coated tablets by Lupin Pharmaceuticals.*
Mirabegron Tablet, Film Coated, Extended Release
Product Images NDC 68180-151
13 FDA label images from Lupin Pharmaceuticals, Inc. · Packaging, Regulatory Labels, and Product Appearance
Product Visual Gallery
This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Mirabegron (NDC 68180-151). 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.
Product Images & Figures Index
Fig 1 (B26f08e4 Dfe4 4a0f B6b5 E9abb495e415 02)
A chart depicting fold change and 90% confidence intervals in pharmacokinetic parameters (AUC and Cmax) of mirabegron when coadministered with various CYP3A/Pgp inhibitors/inducers and other drugs. The x-axis shows mean change relative to mirabegron alone, with comparisons for ketoconazole, rifampicin, solifenacin, tamsulosin, and metformin, along with dose adjustment recommendations.*
Fig 2 (B26f08e4 Dfe4 4a0f B6b5 E9abb495e415 03)
A forest plot chart showing the mean fold change and 90% confidence intervals of pharmacokinetic parameters AUC and Cmax for various CYP3A4, CYP2D6 substrates, and other drugs when taken with mirabegron. The chart includes dosage notes, fold changes relative to substrate alone, and dose adjustment recommendations for each substrate.*
Figure 3 (B26f08e4 Dfe4 4a0f B6b5 E9abb495e415 04)
A line graph showing the 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 with values ranging from 0 to -2. Both groups show a decreasing trend, with the mirabegron 50 mg group exhibiting a greater decrease compared to placebo.*
Figure 4 (B26f08e4 Dfe4 4a0f B6b5 E9abb495e415 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 values. Mirabegron 50 mg data points are marked with squares and connected by a dashed line, showing greater mean reduction over time compared to placebo, which is marked with circles and a solid line.*
Figure 5 (B26f08e4 Dfe4 4a0f B6b5 E9abb495e415 06)
A line graph showing mean change from baseline over 12 weeks comparing placebo and mirabegron 50 mg groups. The x-axis represents time in weeks (baseline, 4, 8, 12), and the y-axis shows mean change from baseline. The graph includes data points with error bars for placebo (circle markers) and mirabegron 50 mg (square markers), showing greater mean change for mirabegron over time.*
Figure 6 (B26f08e4 Dfe4 4a0f B6b5 E9abb495e415 07)
A line graph showing mean change from baseline over time in weeks (0, 4, 8, 12) comparing placebo and mirabegron 50 mg groups. The y-axis measures mean change from baseline, with mirabegron 50 mg showing a greater decrease than placebo across the timeframe, with error bars indicating variability. Placebo corresponds to n=433 and mirabegron 50 mg to n=425 participants.*
Figure 7 (B26f08e4 Dfe4 4a0f B6b5 E9abb495e415 08)
A line graph showing the 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 shows mean change from baseline, with data points and error bars for each group.*
Figure 8 (B26f08e4 Dfe4 4a0f B6b5 E9abb495e415 09)
A line graph depicting mean change from baseline over 12 weeks comparing placebo, mirabegron 25 mg, and mirabegron 50 mg. The x-axis represents weeks (baseline, 4, 8, 12), and the y-axis shows mean change from baseline. Data points with error bars illustrate change trends for each group, showing greater reduction with mirabegron doses than placebo.*
Image (6e53669c 9083 47ad 9bde 3a936703073e 119 1)
Box packaging for MIRABEGRON 25 mg extended-release film-coated tablets. The front panel displays the brand name MIRABEGRON prominently along with the tablet strength of 25 mg. The label indicates it is an extended-release oral tablet. The manufacturer Lupin Pharmaceuticals, Inc. is noted on the box. The package design uses black text on a white background with some decorative black clovers.*
Image (6e53669c 9083 47ad 9bde 3a936703073e 135 1)
MIRABEGRON 25 mg film coated extended release tablet packaging by Lupin Pharmaceuticals, Inc. The image shows a single oval, white tablet blister card with four tablets arranged vertically.*
Image (B26f08e4 Dfe4 4a0f B6b5 E9abb495e415 10)
Label for Mirabegron Extended-Release Tablets 25 mg, oral film-coated tablets for once-daily use. The label indicates it is manufactured for Lupin Pharmaceuticals, Inc. and made in India by Lupin Limited. The package contains 30 tablets and warnings include swallowing whole and keeping out of reach of children.*
Image (B26f08e4 Dfe4 4a0f B6b5 E9abb495e415 11)
Label for Mirabegron Extended-Release Tablets 50 mg by Lupin Pharmaceuticals, Inc. The oral film-coated tablets are to be taken once daily whole, without cutting, crushing, or chewing. The package contains 30 tablets. Manufactured by Lupin Limited in India, with storage instructions at 25°C (77°F) and allowed temperature excursions.*
* 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.
