Pirfenidone Tablet, Film Coated
Product Images NDC 16729-468

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Pirfenidone (NDC 16729-468). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Accord Healthcare 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.

FDA Label Image

267 mg 90 Tablets (Pirfenidone 267mg 90tablets)

Label for Pirfenidone 267 mg film-coated tablets by Accord Healthcare Inc. The label includes dosage strength, Rx only designation, a quantity indication of 90 tablets, and storage instructions. It also shows manufacturer and manufacturing site details, along with barcodes and a placeholder area for lot and expiration data.*

FDA Label Image

801 mg 90 Tablets (Pirfenidone 801mg 90tablets)

Label for Pirfenidone Tablets, 801 mg, film-coated oral tablets from Accord Healthcare Inc. The label indicates a package size of 90 tablets and includes storage instructions, dosage reference to package insert, manufacturing details, and two barcodes. The label features the generic name Pirfenidone prominently with the strength in a magenta box.*

FDA Label Image

Figure 1 (Pirfenidone Figure1)

A cumulative distribution graph showing the percentage of patients on the y-axis and the absolute change in percent predicted forced vital capacity (%FVC) from baseline to week 52 on the x-axis. Two lines represent groups: Pirfenidone (n=278) and placebo (n=277). The graph highlights worsening (decrease in %FVC) versus no decline (increase in %FVC) and compares the patients' response distributions between the treatment and placebo over 52 weeks.*

FDA Label Image

Figure 2 (Pirfenidone Figure2)

A line graph showing mean change in FVC (mL) over 52 weeks comparing Pirfenidone and placebo groups. The x-axis represents weeks (0 to 52), and the y-axis represents mean change in FVC. The solid line with squares indicates Pirfenidone (n=278), and the dashed line with triangles indicates placebo (n=277), illustrating greater decline in FVC in the placebo group over time.*

FDA Label Image

Figure 3 (Pirfenidone Figure3)

A Kaplan-Meier survival curve showing the percentage of patients alive over time (weeks) for two groups: Pirfenidone (n=623) and Placebo (n=624). The graph compares survival rates up to 120 weeks, with corresponding numbers of patients at risk listed below the x-axis. A hazard ratio (HR) with 95% confidence interval is displayed on the chart.*

FDA Label Image

Chemical Structure (Pirfenidone Structural Formula)

Chemical structure of Pirfenidone, showing a pyridone ring methyl-substituted and connected to a phenyl group via 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.