Structure (Mirabegron)
Mirabegron Tablet, Film Coated, Extended Release
Product Images NDC 71335-2807
View Photos of Packaging, Regulatory Labels, and Product Appearance
Product Visual Gallery
This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Mirabegron (NDC 71335-2807). 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.
Product Images & Figures Index
Fig 1 (3e871d38 8ab6 48fa 8c01 Fdbe8c65fd85 02)
This text provides information on the effects of CYP3A/Pgp inhibitors and inducers on the pharmacokinetics (PK) of different drugs. It lists specific drugs such as Ketoconazole, Rifampicin, Salifenacin, Tamsulosin, and Metformin, along with their recommended dosing adjustments based on the fold change and 90% confidence interval (CI) in PK parameters like AUC and Cmax. The text indicates whether dose adjustments are necessary when these drugs are used in combination with the inhibitors or inducers. Additionally, it shows the mean change relative to Mirabegron when used alone.*
Fig 2 (3e871d38 8ab6 48fa 8c01 Fdbe8c65fd85 03)
Figure 3 (3e871d38 8ab6 48fa 8c01 Fdbe8c65fd85 04)
This description appears to be a list of values showing changes from baseline along with the mean change value. The text includes data points for different time intervals (e.g., Week 12) and treatment groups (e.g., placebo and mirabegron 50 mg). This data may be part of a research study or clinical trial evaluating the effects of mirabegron on a specific outcome compared to a placebo.*
Figure 4 (3e871d38 8ab6 48fa 8c01 Fdbe8c65fd85 05)
This text provides a list of changes from the baseline in a study comparing a placebo group to a group taking 50 mg of mirabegron. The data includes measurements at different time points such as 4, 8, and 12 weeks. The text also mentions a total number of participants in each group (480 in the placebo group and 473 in the mirabegron group). No further information is available.*
Figure 5 (3e871d38 8ab6 48fa 8c01 Fdbe8c65fd85 06)
This text appears to be a list of numerical values and headings related to a study or experiment comparing a placebo group to a group taking mirabegron. The values seem to represent changes from a baseline measurement. The data includes the mean change from baseline for different time points such as -1.75, -2.00, and specific weeks are mentioned for each group (placebo and mirabegron 50 mg). The sample sizes (n) for each group are also provided (325 for placebo and 312 for mirabegron).*
Figure 6 (3e871d38 8ab6 48fa 8c01 Fdbe8c65fd85 07)
Not available.*
Figure 7 (3e871d38 8ab6 48fa 8c01 Fdbe8c65fd85 08)
This is a comparison of mean change from baseline in a study evaluating the effects of a placebo, mirabegron 25mg, and mirabegron 50mg on a certain variable over time. The text includes data points ranging from -2.00 to 0.00, indicating the changes observed at different time points.*
Figure 8 (3e871d38 8ab6 48fa 8c01 Fdbe8c65fd85 09)
This is a summary of data showing the mean change from baseline for placebo, mirabegron 25 mg, and mirabegron 50 mg groups at different weeks. The values represent a progression from 0.00 to -2.25 over time. The sample sizes for each group are also provided.*
Label (Lbl713352807)
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. The tablets should be taken once daily by mouth and should be swallowed whole without cutting, crushing, or chewing. Detailed prescribing information can be accessed by scanning the QR code on the package insert. Manufactured by Bryant Ranch Prepack, Inc and Lupin Limited.*
* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.
