Myrbetriq Granule, For Suspension, Extended Release
Product Images NDC 0469-5020

Product Visual Gallery

This gallery contains 18 technical images submitted to the FDA as part of the official labeling for Myrbetriq (NDC 0469-5020). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Astellas Pharma Us, 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.

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Mirabegron Structural Formula (Image 01)

Chemical structure of mirabegron, the active ingredient in Myrbetriq. The structure depicts the molecular arrangement including aromatic rings, hydroxyl group, and amide linkage characteristic of mirabegron.*

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Astellas Logo (Image 02)

Myrbetriq 25 mg film-coated extended-release tablets carton by Astellas Pharma US, Inc. The packaging includes branding, active ingredient mirabegron, dosage form, strength, and quantity information, along with regulatory markings and usage identifiers on a white and orange box.*

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Astellas Logo (Image 03)

Myrbetriq 25 mg film-coated extended-release tablets packaging label from Astellas Pharma US, Inc. The carton displays the brand and generic name mirabegron, dosage strength of 25 mg, and image of a single pink oval tablet. It is an oral prescription medication.*

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Logo.jpg (Image 04)

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Logo.jpg (Image 05)

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25mg Extended Release Tablet Carton (Image 06)

Carton packaging label for Myrbetriq 25 mg extended-release film-coated tablets by Astellas Pharma US, Inc. The label states once-daily oral dosing with instructions to swallow the tablet whole without cutting, crushing, or chewing. The package contains 30 tablets. Additional information includes storage and pharmacist guidance, a barcode, and contact details for patient information.*

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50mg Extended Release Tablet Carton (Image 07)

Packaging label for Myrbetriq 50 mg extended-release film-coated tablets by Astellas Pharma US, Inc. The label instructs to swallow tablets whole without cutting, crushing, or chewing. The bottle contains 30 tablets, for oral once-daily use. Includes contact information for patient inquiries and storage instructions.*

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Figure 1 (Image 08)

A chart showing fold change in pharmacokinetic parameters (AUC and Cmax) with 90% confidence intervals for various CYP3A/Pgp inhibitors and inducers, and other drugs, relative to mirabegron alone. Drugs included are ketoconazole, rifampicin, solifenacin, tamsulosin, and metformin with associated dose regimens. The chart also notes dosing adjustment recommendations, all indicating no dose adjustment necessary.*

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Figure 2 (Image 09)

A pharmacokinetic chart depicting mean fold changes with 90% confidence intervals in AUC and Cmax for various CYP3A4 and CYP2D6 substrates, as well as other drugs, relative to substrate alone. The chart includes drug names and dosages, and corresponding dosing recommendations such as dose adjustment guidance or caution advisories.*

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Figure 3 (Image 10)

A line graph depicting mean change from baseline over a 12-week period 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 from 0 to -2. Data points show decreases over time for both groups, with mirabegron showing a greater decline. Error bars indicate variability.*

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Figure 4 (Image 11)

A line graph showing mean change from baseline over weeks 4, 8, and 12 comparing placebo and mirabegron 50 mg. The vertical axis represents mean change from baseline in a negative scale, and the horizontal axis represents time in weeks. Mirabegron 50 mg shows a greater decrease from baseline compared to placebo over time, with error bars indicating variability.*

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Figure 5 (Image 12)

A line graph showing mean change from baseline over weeks (0, 4, 8, 12) comparing placebo (n=325) and mirabegron 50 mg (n=312). The y-axis represents mean change from baseline, while the x-axis represents weeks. The mirabegron 50 mg group shows a greater decrease compared to placebo throughout the study period.*

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Figure 6 (Image 13)

A line graph comparing mean change from baseline over 12 weeks for placebo and mirabegron 50 mg groups. The x-axis represents weeks (BL, 4, 8, 12), and the y-axis represents mean change from baseline. Placebo is shown with circles and a solid line, mirabegron 50 mg with squares and a dashed line, both with error bars. Sample sizes are 433 for placebo and 425 for mirabegron 50 mg.*

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Figure 7 (Image 14)

A line graph depicting 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, 12) and the y-axis shows mean change from baseline. Three lines represent placebo, mirabegron 25 mg, and mirabegron 50 mg, with error bars at each data point.*

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Figure 8 (Image 15)

A line graph showing mean change from baseline over 12 weeks comparing placebo, mirabegron 25 mg, and mirabegron 50 mg groups. The x-axis represents weeks (BL, 4, 8, 12) and the y-axis shows mean change from baseline ranging from 0 to -2.25. Data points include error bars, with three distinct lines for placebo, mirabegron 25 mg, and mirabegron 50 mg.*

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Figure 9 (Image 16)

A line graph depicting adjusted change from baseline over time for different treatment groups including placebo, Myrbetriq (mirabegron) 25 mg and 50 mg, solifenacin 5 mg, and their combinations. The x-axis shows visits from baseline through week 12 and end of treatment, while the y-axis shows adjusted change from baseline. The graph includes error bars for mean values at each time point.*

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Figure 10 (Image 17)

A line graph showing adjusted change from baseline over multiple visits (Baseline, Week 4, Week 8, Week 12, and End of Treatment) for various treatment groups including Placebo, Myrbetriq 25 mg, Myrbetriq 50 mg, and combinations of solifenacin (S) plus Myrbetriq (M) 25 mg and 50 mg. The y-axis represents the adjusted change from baseline, with multiple lines corresponding to each treatment group and error bars indicating variability.*

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Myrbetriq Granules Carton Image (Image 18)

Myrbetriq Granules 8 mg/mL oral suspension carton label for extended-release granules containing mirabegron. The label indicates a 100 mL bottle size with instructions for preparation and administration. The product is marketed by Astellas Pharma US, Inc. and includes patient and pharmacist information, dosage instructions, and handling precautions.*

* 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.