Macitentan Tablet, Film Coated
Product Images NDC 69238-1327

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Macitentan (NDC 69238-1327). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Amneal Pharmaceuticals Ny Llc, 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

S (Macitentan Tablets 10 mg 1)

FDA Label Image

1 (Macitentan Tablets 10 mg 2)

FDA Label Image

2 (Macitentan Tablets 10 mg 3)

This data pertains to a clinical study involving Macitentan 10mg compared to a placebo in terms of event-free survival. The results show a 63.18% event-free rate with Macitentan compared to a placebo group, with a hazard ratio of 0.547. The Kaplan-Meier analysis indicates a statistically significant difference between the two groups (p-value <.0001). Also displayed are the number of patients at risk in each group at different time points throughout the study period.*

FDA Label Image

5 (Macitentan Tablets 10 mg 4)

This is not available.*

FDA Label Image

6 (Macitentan Tablets 10 mg 5)

This text provides data on a clinical trial comparing Macitentan 10 mg to a placebo. The results show a Hazard Ratio of 0.500 with a 97.5% Confidence Interval of (0.335, 0.747) and a significant Logrank p-value of <0.0001. The number of patients at risk over months from treatment start is also presented in the table.*

FDA Label Image

1 (Macitentan Tablets 10 mg 6)

This text provides information about Macitentan tablets, including the recommended dosage of 10mg daily. It also mentions storage instructions and manufacturer details. Additionally, the text includes a lot number and relevant pharmaceutical information.*

FDA Label Image

2 (Macitentan Tablets 10 mg 7)

This excerpt provides information about a medication called Macitentan, which comes in film-coated tablets with a strength of 10mg. The recommended dosage is to be taken orally. The tablets are manufactured by Amneal Pharmaceuticals P Ltd. and distributed by Amneal Pharmaceuticals LLC. The prescription for this medication is for 30 tablets with a specific license number mentioned. The text also advises the pharmacist to dispense the accompanying Medication Guide to each patient. Instructions are given to keep the medication out of reach of children and not to use it if the seal over the bottle opening is broken or missing.*

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