Pirfenidone Tablet, Film Coated
Product Images NDC 42571-336

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Pirfenidone (NDC 42571-336). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Micro Labs 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.

FDA Label Image

Pirfenidone-267mg-lbl.jpg (Pirfenidone 267mg Lbl)

Label for Pirfenidone Tablets 267 mg, film-coated oral tablets. The label states NDC 42571-335-90 and a package count of 90 tablets. It includes storage instructions to keep at 25°C (77°F) with permitted excursions and a caution to keep out of reach of children. Manufactured for Micro Labs USA, Inc., Somerset, NJ.*

FDA Label Image

Pirfenidone-801mg-lbl.jpg (Pirfenidone 801mg Lbl)

Label for Pirfenidone Tablets 801 mg oral film-coated tablets, with a package count of 90 tablets. The label indicates the manufacturer as Micro Labs USA, Inc., Somerset, NJ, with revision date 02/2022. Storage instructions and dosage directions reference the package insert. The NDC is 42571-336-90.*

FDA Label Image

Figure 1 (Pirfenidone Figure1)

A cumulative distribution plot comparing the percentage of patients treated with Pirfenidone versus placebo, showing absolute change in percent predicted forced vital capacity (%FVC) from baseline to week 52. The horizontal axis represents the change in %FVC, while the vertical axis indicates the cumulative percentage of patients. The graph distinguishes worsening (decrease in %FVC) from no decline (increase in %FVC).*

FDA Label Image

Figure 2 (Pirfenidone Figure2)

A line graph showing the mean change in Forced Vital Capacity (FVC) over 52 weeks comparing Pirfenidone (solid line) and placebo (dashed line) groups. The x-axis represents weeks, and the y-axis shows the change in FVC in milliliters. Pirfenidone shows a smaller decline in FVC compared to placebo over time.*

FDA Label Image

Figure 3 (Pirfenidone Figure3)

A survival curve graph showing the percentage of patients alive over time in weeks up to 120 weeks, comparing two groups: Pirfenidone (n=623) and Placebo (n=624). The graph includes a hazard ratio (HR) with 95% confidence interval (CI) of 0.75 (0.51-1.11) indicating comparative survival outcomes. Patient numbers at risk are shown at multiple time points for both groups.*

FDA Label Image

Structure (Pirfenidone Structure)

Chemical structure diagram of Pirfenidone, showing the molecular arrangement with a methyl group and a ketone functional group attached to a pyridine ring connected to a phenyl ring through a nitrogen atom.*

* 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.