Mirabegron Tablet, Film Coated, Extended Release
Product Images NDC 71335-2809

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Mirabegron (NDC 71335-2809). 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)

FDA Label Image

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

This text appears to be a table listing different drugs (such as Ketoconazole, Rifampicin, Solifenacin, Tamsulosin, and Metformin) and their effects on the pharmacokinetics (PK) of another drug (mirabegron). The table shows information related to AUC, Cmax, and the need for dose adjustment when these drugs are used in combination with mirabegron. It provides a quick reference guide for healthcare professionals on the interactions between these drugs and mirabegron.*

FDA Label Image

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

This information provides guidance on the pharmacokinetics of various drugs in relation to CYP3M and CYP2D6 substrates. It includes details on fold changes in AUC and Cmax values for solifenacin, ethinylestraciol, levonorgestrel, desipramine, metoprolol, tamsulosin, digoxin, warfarin, and metformin. Recommendations for dose adjustments are also mentioned for some of these drugs.*

FDA Label Image

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

This text appears to show a table or list of numerical values representing changes from a baseline measurement at different time points for a placebo group and a mirabegron 50 mg group. The mean change from the baseline is also included in this data set. The data seems to be related to a study or experiment involving 291 participants in the placebo group and 293 in the mirabegron 50 mg group at week 12. Additional context is needed to provide a more detailed description.*

FDA Label Image

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

This is a list of numerical values for different measurements and mean changes from baseline over time in a study comparing a placebo group (n=480) with a mirabegron 50 mg group (n=473). Week measurements are included at BL (baseline), 4, 8, and 12.*

FDA Label Image

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

This text appears to be a table showing values for different time points and treatments in a study. It includes baseline values, mean change from baseline, and the number of participants for each treatment group. The treatments mentioned are placebo and mirabegron 50 mg. The data seems to be related to a clinical trial or research study comparing the effects of the two treatments over 12 weeks.*

FDA Label Image

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

This is a table showing the mean change from baseline in a study comparing a placebo group (n=433) with a group taking mirabegron 50 mg (n=425) over the course of several weeks. The data can be used to evaluate the effectiveness of mirabegron compared to a placebo in the study.*

FDA Label Image

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

This is a data table showing the mean change from baseline for different time points and treatment groups in a study evaluating the effects of a placebo and two different doses of mirabegron. The data includes the mean change in values from baseline for each week and treatment group.*

FDA Label Image

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

This data appears to show different values for mean change from baseline for placebo, mirabegron 25 mg, and mirabegron 50 mg at various time points. The measurements are taken at baseline, week 4, week 8, and week 12, with corresponding values like 0.00, -2.25, -1.75, etc., for each treatment group. The information indicates a study or clinical trial comparing the effects of these treatments on a particular outcome.*

FDA Label Image

Label (Lbl713352809)

Each tablet of Mirabegron contains 25 mg of the active ingredient. It is recommended to store the tablets in a tight container at room temperature, between 15°C to 30°C. The usual dosage is once daily by mouth. For complete prescribing information, you can scan the provided QR code on the package insert. It is important to keep this medication out of reach of children and swallow the tablet whole without cutting, crushing, or chewing it.*

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