Mirabegron Tablet, Film Coated, Extended Release
Product Images NDC 71335-2808

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Mirabegron (NDC 71335-2808). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Bryant Ranch Prepack, 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)

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Fig 1 (3e871d38 8ab6 48fa 8c01 Fdbe8c65fd85 02)

This is a list of CYP3A/Pgp inhibitors and inducers along with their impact on PK parameters like AUC and Cmax. The text provides specific recommendations for dose adjustments associated with drugs like Ketoconazole and Rifampicin. Additionally, it includes information on drugs like Solifenacin, Tamsulosin, and Metformin and their effects on AUC and Cmax. The mean change relative to mirabegron alone is also mentioned in the text.*

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Fig 2 (3e871d38 8ab6 48fa 8c01 Fdbe8c65fd85 03)

This is a list of different drugs and their recommended dose adjustments based on their interactions with enzymes like CYP3A and CYP2D6. For example, solifenacin and ethinylestradiol do not require dose adjustments, while desipramine and tamsulosin do not need dose adjustments for CYP2D6 substrates as well. Levonorgestrel and digoxin also do not require dose adjustments. Additionally, the text mentions other drugs like warfarin and metformin and specifies their dose adjustments.*

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Figure 3 (3e871d38 8ab6 48fa 8c01 Fdbe8c65fd85 04)

This is a list showing numerical values from 0.00 to 12, with incremental intervals of -0.25. The text mentions "Mean Change from Baseline" along with data for the placebo group (n=291) and the Mirabegron 50 mg group (n=293) at week 12. It seems to be a summary of results from a study or experiment evaluating the effects of Mirabegron.*

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Figure 4 (3e871d38 8ab6 48fa 8c01 Fdbe8c65fd85 05)

This information seems to be a comparison of mean change from baseline for a study involving a placebo group and a group treated with mirabegron 50 mg. The data shows values at varying time points. The mean change from baseline seems to decrease over time starting from 0.00 to -2.25. The study might have lasted for 12 weeks with data collected at weeks 4, 8, and 12. It appears that the groups consisted of 480 participants in the placebo group and 473 participants in the mirabegron 50 mg group.*

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Figure 5 (3e871d38 8ab6 48fa 8c01 Fdbe8c65fd85 06)

This text appears to be a list showing changes over time for a study comparing a placebo group to a group taking mirabegron 50 mg. The values indicate a decrease in some form of measurement from baseline to 12 weeks. It seems that the mean change from baseline is also included. The sample sizes for the placebo and mirabegron groups are specified (n=325 and n=312, respectively).*

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Figure 6 (3e871d38 8ab6 48fa 8c01 Fdbe8c65fd85 07)

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Figure 7 (3e871d38 8ab6 48fa 8c01 Fdbe8c65fd85 08)

This data provides measurements of changes from the baseline at different time points for a study comparing the efficacy of a placebo and two different doses of mirabegron. The mean change from the baseline is recorded at various intervals over time. The study has three groups: placebo, mirabegron 25 mg, and mirabegron 50 mg, with different sample sizes for each group. The data seems to indicate the effect of mirabegron on the study participants over the specified time periods.*

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Figure 8 (3e871d38 8ab6 48fa 8c01 Fdbe8c65fd85 09)

This text appears to contain a tabulated list of values representing change from baseline over different weeks in a study involving placebo and two different dosages of mirabegron (25 mg and 50 mg). The data includes numbers such as 0.00, 0.25, -0.50, -0.75, -1.75, -2.00, -2.25, and mentions after how many weeks the measurement was taken (e.g., at 4, 8, and 12 weeks). This data seems to be part of an evaluation of the effectiveness of mirabegron at different dosages.*

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Label (Lbl713352808)

Each tablet contains 50 mg of Mirabegron and is intended for oral use once daily. The packaging includes important safety information and a QR code for complete prescribing details. Store in a tight container at 25°C (77°F) with excursions permitted to 15°-30°C (59°-86°F). Manufactured by Bryant Ranch Prepack, Inc., and distributed by Lupin Limited. Keep out of reach of children and swallow the tablet whole without cutting, crushing, or chewing.*

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.