Esbriet
Product Images NDC 64116-121

6 FDA label images from Intermune, Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Esbriet (NDC 64116-121). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Intermune, 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.

Product Images & Figures Index

FDA Label Image

Chemical Structure (Esbriet Figure 1)

Chemical Structure (Esbriet Figure 1)
Chemical structure diagram of pirfenidone, the active ingredient in Esbriet. The structure shows a pyridone ring bonded to a benzene ring through a nitrogen atom, with a methyl group attached to the pyridine ring.*
FDA Label Image

Figure 1 (Esbriet Figure 2)

Figure 1 (Esbriet Figure 2)
A cumulative distribution plot showing the percentage of patients versus absolute change in percent forced vital capacity (%FVC) from baseline to week 52. Two lines represent Esbriet (n=278) and placebo (n=277) groups, illustrating worsening (decrease in %FVC) and no decline (increase in %FVC). Markers on the graph indicate percentages of patients experiencing specific changes in %FVC.*
FDA Label Image

Figure 1 (Esbriet Figure 3)

Figure 1 (Esbriet Figure 3)
A line graph showing mean change in Forced Vital Capacity (FVC) in milliliters over 52 weeks comparing Esbriet (n=278) to placebo (n=277). The graph indicates a less steep decline in FVC for patients on Esbriet compared to placebo across the study period.*
FDA Label Image

Figure 1 (Esbriet Figure 4)

Figure 1 (Esbriet Figure 4)
A Kaplan-Meier survival curve comparing percentage of patients alive over time (weeks) for Esbriet (n=623) versus placebo (n=624). The graph shows patient survival from approximately 0 to 120 weeks, with a hazard ratio (HR) and 95% confidence interval (CI) provided. Patients at risk are listed below the x-axis for both Pirfenidone (Esbriet) and placebo groups at multiple time points.*
FDA Label Image

Capsules Carton (Esbriet Figure 5)

Capsules Carton (Esbriet Figure 5)
Packaging label for Esbriet (pirfenidone) capsules, 267 mg, manufactured for InterMune, Inc. The label shows the product name and strength multiple times along with instructions to keep out of reach of children. It indicates Rx only and specifies a total count of 270 capsules. Storage instructions note 25°C with permitted excursions. Barcodes and lot/expiration placeholders are also included.*
FDA Label Image

Capsules Label (Esbriet Figure 6)

Capsules Label (Esbriet Figure 6)
The image shows the label for Esbriet capsules, containing 267 mg of the active ingredient pirfenidone. It indicates the product is manufactured for InterMune, Inc., with NDC 64116-121-01. The label includes storage instructions, a barcode, and the quantity of 270 capsules. Dosage and administration information refer to the package insert.*

* 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.