Mirabegron Tablet, Film Coated, Extended Release
Product Images NDC 67184-0571

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Mirabegron (NDC 67184-0571). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Qilu Pharmaceutical Co., Ltd., 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

Bottle Label, 25 mg- 30 Tablets (Bottle Label 25mg 30tablets)

This text provides important details about a medication containing 25 mg of mirabegron per tablet. It emphasizes swallowing the tablet whole and avoiding cutting, crushing, or chewing it. There are instructions to store the medication at a temperature between 20°C to 25°C (68°F to 77°F) with excursions permitted within 15°C to 30°C (59°F to 86°F). The usual dosage is once daily by mouth. The medication is manufactured by Qilu Pharmaceutical Co., Ltd. in China. Pharmacist dispensing instructions are also included.*

FDA Label Image

Bottle Label, 25 mg- 90 Tablets (Bottle Label 25mg 90tablets)

Each tablet of NDC 67184-0571-2 contains 25 mg of mirabegron. It is recommended to swallow the tablet whole and avoid cutting, crushing, or chewing it. The tablets should be stored at 20°C to 25°C (68°F to 77°F) with excursions permitted from 15°C to 30°C (59°F to 86°F). The usual dosage is once daily by mouth. Detailed prescribing information is available. These tablets are manufactured by Qilu Pharmaceutical Co., Ltd. in Jinan, China.*

FDA Label Image

Bottle Label, 50 mg- 30 Tablets (Bottle Label 50mg 30tablets)

This text provides information about a medication with the NDC code 67184-0572-1. Each tablet contains 50 mg of mirabegron, and it is recommended to swallow the tablet whole without cutting, crushing, or chewing. The medication should be stored at 20°C to 25°C (68°F to 77°F), with excursions permitted from 15°C to 30°C (59°F to 86°F). It should be kept out of reach of children and dispensed in a tight container. The usual dosage is once daily by mouth. For complete prescribing information, refer to the packaging. The tablets are manufactured by Qilu Pharmaceutical Co., Ltd in Jinan, China.*

FDA Label Image

Bottle Label, 50 mg- 90 Tablets (Bottle Label 50mg 90tablets)

Each tablet contains 50 mg of mirabegron. Swallow tablet whole. Do not cut, crush, or chew tablet. Store at 20°C to 25°C (68°F to 77°F). Extended-release. Recommended dosage: Once daily by mouth. Manufacturer: Qilu Pharmaceutical Co., Ltd. From Jinan, China. It is important to keep this medication out of reach of children.*

FDA Label Image

Mirabegron Structural Formula (Image 01)

FDA Label Image

Figure 1 (Image 02)

This text provides a list of different inhibitors and inducers related to CYP3A/Pgp enzymes along with their effects on PK (pharmacokinetics) parameters like AUC (area under the curve) and Cmax (maximum concentration). It also includes recommendations regarding dose adjustments based on the fold change observed in these parameters. Specific drugs such as Ketoconazole, Rifampicin, Solifenacin, Tamsulosin, and Metformin are mentioned with the respective effects on AUC and Cmax. Additionally, it references a mean change relative to mirabegron alone, it indicates that no dose adjustment is needed in most cases.*

FDA Label Image

Figure 2 (Image 03)

This data table provides information on the impact of CYP3A4 and CYP2D6 substrates on the pharmacokinetics of various drugs. It includes details on the fold change in PK and 90% confidence intervals for solifenacin, ethinylestradiol, levonorgestrel, desipramine, metoprolol, tamsulosin, digoxin, warfarin, and metformin. Recommendations for dose adjustments and cautions are also mentioned for each drug interaction.*

FDA Label Image

Figure 3 (Image 04)

The text provides information on the mean change from baseline for placebo (n=291) and mirabegron 50 mg (n=293) groups at weeks 4, 8, and 12. This data can be used to evaluate the effectiveness of mirabegron 50 mg compared to placebo over time.*

FDA Label Image

Figure 4 (Image 05)

This text includes numeric values representing changes from baseline measurements in a study involving a placebo group and a group taking mirabegron 50 mg. The data shown consists of mean changes at various time points in the study.*

FDA Label Image

Figure 5 (Image 06)

This is a table showing different numerical values such as 0.004, -0.25, -0.50, -0.75, -1.004, -1.25, -1.50, -1.75, -2.00, and more. The document might be related to a study or research with placebo and mirabegron 50 mg groups. The text also mentions "Mean Change from Basel" and "BL 4 8 12."*

FDA Label Image

Figure 6 (Image 07)

This text provides a list of numbers (-0.25, -0.50, -0.75) and symbols (I I I, - - -, o N o, =] o =]), as well as values indicating mean change from baseline (-1.75, -2.00, -2.25). Additionally, there is a comparison between a placebo group (n=433) and a group taking mirabegron 50 mg (n=425) after 12 weeks. The text seems to be part of a study or report about the effectiveness of mirabegron.*

FDA Label Image

Figure 7 (Image 08)

This is a data table showing the mean change from baseline for different treatment groups over a series of weeks (4, 8, and 12). The table includes values for the placebo group (n=262), mirabegron 25 mg group (n=254), and mirabegron 50 mg group (n=257). The mean changes from baseline range from -1.50 to -2.00. The total change calculated as 1.251 is not directly related to the mean change values.*

FDA Label Image

Figure 8 (Image 09)

This data provides information on the mean change from baseline in a study evaluating the effects of a drug (mirabegron) at different dosages (25 mg and 50 mg) compared to a placebo. The text mentions a timeline of weeks (4, 8, 12) and provides the sample sizes of each group (placebo, mirabegron 25 mg, mirabegron 50 mg) as 415, 410, and 426 respectively.*

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