Structure (Mirabegron)
Mirabegron Tablet, Film Coated, Extended Release
Product Images NDC 68180-151
View Photos of Packaging, Regulatory Labels, and Product Appearance
Product Visual Gallery
This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Mirabegron (NDC 68180-151). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by Lupin Pharmaceuticals, 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
Fig 1 (Df9595b1 E4de 4e5f A76a 6d89e139303d 02)
This text provides information on the effects of different drugs on the pharmacokinetics (PK) of Mirabegron. It lists examples of CYP3A/Pgp inhibitors/inducers, their recommended dosages, and the fold change in AUC and Cmax. The drugs mentioned include Ketoconazole, Rifampicin, Salifenacin, Tamsulosin, and Metformin. The data suggests whether dose adjustments are necessary with Mirabegron when co-administered with these medications.*
Fig 2 (Df9595b1 E4de 4e5f A76a 6d89e139303d 03)
Figure 3 (Df9595b1 E4de 4e5f A76a 6d89e139303d 04)
This is a list showing changes from baseline values for different time points in a study comparing a placebo group with a group receiving 50 mg of mirabegron. The data includes mean changes and sample sizes for each group at different weeks.*
Figure 4 (Df9595b1 E4de 4e5f A76a 6d89e139303d 05)
This is a comparison chart showing the mean change from baseline in a study evaluating the effectiveness of Mirabegron 50 mg compared to a placebo over a certain period of time. The chart includes data points at different intervals and specifies the number of participants for each group.*
Figure 5 (Df9595b1 E4de 4e5f A76a 6d89e139303d 06)
This is a set of numbers indicating a decrease from baseline scores in a study comparing placebo with mirabegron 50mg. The sample size for placebo is 325 and for mirabegron 50mg is 312. The mean change from baseline is decreasing in value.*
Figure 6 (Df9595b1 E4de 4e5f A76a 6d89e139303d 07)
Figure 7 (Df9595b1 E4de 4e5f A76a 6d89e139303d 08)
This is a table showing the mean change from baseline for different time points in a study comparing mirabegron (25mg and 50mg) to a placebo. The changes in values are displayed at intervals ranging from 0.00 to -2.00 over the course of the study.*
Figure 8 (Df9595b1 E4de 4e5f A76a 6d89e139303d 09)
This text appears to be a table showing numerical values of mean changes from baseline for different treatments and time points. It also includes information about the number of participants for each treatment group. The data includes values ranging from -1.75 to -2.25 with references to placebo, mirabegron 25 mg, and mirabegron 50 mg. The table seems to be related to a clinical trial or study evaluating the efficacy of mirabegron at different doses over time.*
Bottle Label (25 mg)
This is a description for a medication named "Mirabegron." The tablets come in a pack with NDC 68180-151-06. The typical dosage is once a day taken orally. Storage instructions include storing at room temperature and protecting from excursions (permitted within a specified range). The manufacturer is identified as Lupin Pharmaceuticals, Inc., located at Baltimore, Maryland. The tablets should be swallowed whole and not cut, crushed, or chewed. It is an extended-release formulation and should be kept out of reach of children. There are 30 tablets per pack.*
Image 11 (Df9595b1 E4de 4e5f A76a 6d89e139303d 11)
This is a medication package insert for Mirabegron Extended-Release Tablets, with a dosage of 25 mg. It is intended for once-daily use and should be swallowed whole without cutting, crushing, or chewing. The tablets should be stored at room temperature. The product is manufactured by Lupin Pharmaceuticals and dispensed in a tight container with safety closures. The text also includes information about the manufacturer's address and contact details.*
Bottle Label (50 mg)
This text provides information about a medication with the NDC 68180-152-06, containing 50 mg of mirabegron per tablet. The recommended dosage is once daily by mouth. It advises against cutting, crushing, or chewing the tablet, and to swallow it whole. The tablets are extended-release and should be stored at 25°C (77°F), with excursions permitted to 15°C to 30°C. The medication should be kept out of reach of children. The product is manufactured by Lupin Limited, and the package contains 30 tablets. *
Image 13 (Df9595b1 E4de 4e5f A76a 6d89e139303d 13)
The text is not clearly readable.*
* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.
