Chemical Structure (Opsumit 01)
Opsumit Tablet, Film Coated
Product Images NDC 66215-501
View Photos of Packaging, Regulatory Labels, and Product Appearance
Product Visual Gallery
This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Opsumit (NDC 66215-501). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by Actelion Pharmaceuticals Us, 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.
Figure 1 (Opsumit 02)
This appears to be a table showing the interaction of the drug macitentan and other drugs (Sidonati, Coue, Cyclosporine-a, Avce, Ketoconazole, and Ritampin) in terms of their estimated impact on AUCw (Area Under Concentration Curve) with respective point estimates and 0-90% confidence intervals. The recommendation for each interaction is either "No dose adjustment" or "Avoid".*
Figure 2 (Opsumit 03)
This is a tabular representation of clinical trial results in which 242 participants were treated with OPSUMIT 10mg and 250 were treated with a placebo. The table shows the number at risk and the percentage for each group over a period of several months from treatment start. The Hazard Ratio is 0.547 and Logrank p-value is <.0001, suggesting that OPSUMIT 10mg is effective in reducing the risk of cardiovascular disease compared to placebo.*
Figure 3 (Opsumit 04)
This is a table showing the hazard ratio and confidence interval of various factors on the primary end point in clinical trials of a drug called OPSUMIT. The factors include age, gender, race, comorbidities, geographical region, and baseline characteristics. The data on patients under 18 is also mentioned.*
Figure 4 (Opsumit 05)
This is the summary of a clinical trial evaluating the efficacy of OPSUMIT 10 mg compared to a placebo. The data shows the percentage of patients who remained event-free (Kaplan-Meier) at different time points over a 62-month period. The hazard ratio, confidence interval, and logrank p-value are also provided. The number of patients at risk and the months from the start of treatment are shown in a table. The text ends abruptly with a single digit, making it unclear whether there is further information.*
Figure (Opsumit 06)
This is a description of acceptable birth control options, including various methods such as the pill, intrauterine devices, condoms, diaphragms, cervical caps, spermicides, and implants. The different options are separated into four categories, with each category consisting of possible combinations of methods. Some of the methods listed include hormonal birth control, barrier methods, and surgical options.*
Principal Display Panel (10 mg Tablet Bottle Carton)
* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.
