Zileuton Tablet, Multilayer, Extended Release
Product Images NDC 64380-189

View Photos of Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 3 technical images submitted to the FDA as part of the official labeling for Zileuton (NDC 64380-189). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Strides Pharma Science Limited, 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

FDA Label Image

Chemical Structure Of Zileuton (3c61db22 C5f4 45c8 9ace 386dd4267c12 01)

Chemical Structure Of Zileuton (3c61db22 C5f4 45c8 9ace 386dd4267c12 01)
Chemical structure of zileuton showing a fused thienyl and benzene ring system attached to a hydroxyl and urea functional groups.*
FDA Label Image

Figure 1. Mean Change From Baseline In Trough Fev1 In 12-week Clinical Trial In Patients With Asthma. (3c61db22 C5f4 45c8 9ace 386dd4267c12 02)

Figure 1. Mean Change From Baseline In Trough Fev1 In 12-week Clinical Trial In Patients With Asthma. (3c61db22 C5f4 45c8 9ace 386dd4267c12 02)
A line chart comparing mean change from baseline in trough FEV1 (L) over a double-blind study period between Zileuton Extended-Release Tablets and placebo. The chart shows time points from week 0 to endpoint, with Zileuton consistently showing greater improvement than placebo. A sample size table is included below the graph for both groups at each time point.*
FDA Label Image

Image (3c61db22 C5f4 45c8 9ace 386dd4267c12 03)

Image (3c61db22 C5f4 45c8 9ace 386dd4267c12 03)
Label for Zileuton Extended-Release Tablets 600 mg, oral multilayer extended-release tablets by Strides Pharma Inc. The label states the dosage of 2 tablets twice daily and a total of 120 tablets per container. It includes NDC 64380-189-01, storage instructions, and a barcode.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.