Structure (77f4fa2d 8c1c 4906 880f B6c1c10f2655 01)
Mirabegron Tablet, Extended Release
Product Images NDC 70518-4631
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Product Visual Gallery
This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Mirabegron (NDC 70518-4631). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by Remedyrepack 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
Figure 1 (77f4fa2d 8c1c 4906 880f B6c1c10f2655 02)
This text provides information about the impact of CYP3A/Pgp inhibitors/inducers on drug PK (pharmacokinetics), presenting fold change and 90% confidence interval recommendations. It lists specific medications such as Ketoconazole and Rifampicin along with their recommended dosages and any necessary adjustments. It also mentions other drugs like Solfenadin, Tamsulosin, and Metformin, indicating whether dose adjustment is needed. Additionally, it includes a graph showing the mean change relative to mirabegron alone.*
Figure 2 (77f4fa2d 8c1c 4906 880f B6c1c10f2655 03)
This text seems to be a list of different drugs classified as CYP3A4 and CYP2D6 substrates, along with their respective recommended doses and potential interactions. Specific drugs mentioned include Saifenadin, Etinylestradial, Levonorgestrel, Desipramine, Metoprolol, Tamoxifen, Digoxin, Warfarin, and Metformin. It also provides information on PK fold change, AUC, Qmax, and dose adjustment recommendations for each substrate.*
Figure 3 (77f4fa2d 8c1c 4906 880f B6c1c10f2655 04)
Figure 4 (77f4fa2d 8c1c 4906 880f B6c1c10f2655 05)
This text appears to be a list of numerical values and some reference to a study or trial involving a placebo and mirabegron 50 mg in a sample size of 480 and 473, respectively. The numbers seem to represent data points or changes.*
Figure 5 (77f4fa2d 8c1c 4906 880f B6c1c10f2655 06)
This text provides a table showing the mean change from baseline for different values ranging from 0.00 to -2.00. The data compares the placebo group (n=325) with the mirabegron 50 mg group (n=312) at week 12. The values listed are the mean changes in the respective groups.*
Figure 6 (77f4fa2d 8c1c 4906 880f B6c1c10f2655 07)
Figure 7 (77f4fa2d 8c1c 4906 880f B6c1c10f2655 08)
This text provides data on the mean change from baseline values at different intervals, including 0.0, -0.25, -0.50, -0.75, -1.0, -1.25, -1.50, -1.75, -2.0. It also includes information regarding a study group with different dosages of mirabegron, 25 mg, and 50 mg, with a sample size of 257 individuals.*
Figure 8 (77f4fa2d 8c1c 4906 880f B6c1c10f2655 09)
This text appears to show a list of values followed by a comparison of changes between different groups in a study. It includes the mean change from baseline and specific data related to a study involving different doses of mirabegron and a placebo.*
Mm1 (Mirabegron 25mg 70518 4631 00)
This is a description of a medication package containing 50 tablets of erabegron manufactured by Zydus Pharm in Pennington, NJ. The tablets are extended-release 25 mg each and should be stored at 20-25°C (68-77°F) with excursions permitted to 15-30°C (59-86°F). The usual dosage information is available in the insert. The package was repackaged by RemedyRepack Y Inc. in Indiana, PA. For more detailed information, refer to the medication insert.*
Remedy_label (Remedy Label)
This is information about a 25mg tablet of Mirabegron manufactured by Zydus Pharmaceuticals, located in Pennington, NJ. It is an extended-release tablet with usual dosage instructions provided in the insert. The tablet should be stored at a temperature range of 20-25°C (68-77°F), with excursions permitted to 15-30°C (59-86°F). The tablet is repackaged by RemedyRepack Inc. located in Indiana, PA, and the contact number is 724-465-8762.*
* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.
