Chemical Structure (Sirturo 01)
Sirturo Tablet
Product Images NDC 59676-702
View Photos of Packaging, Regulatory Labels, and Product Appearance
Product Visual Gallery
This gallery contains 4 technical images submitted to the FDA as part of the official labeling for Sirturo (NDC 59676-702). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by Janssen Products, Lp, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.
Figure 1 (Sirturo 02)
This text presents information about the distribution of Bedaquiline Agar and Bedaquiline REMA MIC against baseline clinical isolates from different studies and subjects. The data includes the MIC values in ug/mL and sg/mL for various concentrations ranging from 0.003 to 0.5 ug/mL.*
Principal Display Panel (20 mg Tablet Bottle Label)
This text contains information regarding the dosage, storage, and safety precautions for a medication called Sirturo, specifically stating that it should not be taken with "SIRTURG." The medication should be stored at a controlled room temperature, protected from light and moisture, and kept out of reach of children. The product is manufactured in India and distributed by Janssen Products. The tablet contains 20mg of bedaquilne, and the package contains 60 tablets. The expiration date and lot number are also available.*
Principal Display Panel (100 mg Tablet Bottle Label)
Sirturo (bedaquiline) tablets contain 100 mg of bedaquiline, equivalent to 120.89 mg of bedaquiline Ifumarate. The recommended dosage information is available in the package insert along with full prescribing information. It is essential to keep the product out of reach of children. Medicines that should not be taken with Sirturo® should be identified by consulting a doctor or pharmacist. Sirturo is manufactured in India by Recipharm Pharmaservices Pyt Lid., Bangalore, and is manufactured for Janssen Therapeutics, Division of Janssen Products, LP. The tablets need to be dispensed in the original container, and tablets outside the container should be kept in a light-resistant container, out of reach of children, with an expiration date not to exceed three months. Storage temperature must not exceed 25°C (77°F), with excursions permitted to 15°C-30°C (59°F - 86°F).*
* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.
