Pirfenidone Tablet, Film Coated
Product Images NDC 72603-259

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Pirfenidone (NDC 72603-259). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Northstar Rx 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

Pirfenidone-267mg-270s-carton-lbl.jpg (Pirfenidone 267mg 270s Carton Lbl)

This text provides information about Pirfenidone Tablets with NDC 72603-258-03. Each film-coated tablet contains 267 mg of pirfenidone. The packaging includes 270 tablets (3 bottles of 90 tablets each). It is advised to keep these tablets out of reach of children and follow the dosage instructions provided on the package insert. The tablets should be stored at a temperature of 25°C (77°F) with excursions permitted to 15° to 0°C (59° to 86°F). The tablets are manufactured for Northstar Rx LLC, Memphis, TN 38141, and manufactured by SN Laboratories Private Limited in Telangana, India.*

FDA Label Image

Pirfenidone-267mg-90s-cont-lbl.jpg (Pirfenidone 267mg 90s Cont Lbl)

This is information about Pirfenidone tablets with 90 tablets in the pack. Each film-coated tablet contains 267 mg of pirfenidone. The usual dosage information can be found in the package insert. The tablets should be stored at 25°C (77°F) with excursions permitted to 15° to 30°C (59° to 86°F). The manufacturer is Northstar Rx LLC in Memphis, TN, and they are manufactured by MSN Laboratories Private Limited in Telangana, INDIA, with the copyright belonging to Northstar Healthcare Holdings Ltd. The manufacturing license number is 5/MNITS/2014/FIG. This information was issued in March 2024.*

FDA Label Image

Pirfenidone-801mg-90s-cont-lbl.jpg (Pirfenidone 801mg 90s Cont Lbl)

Each film-coated tablet contains pirfenidone, 801 mg. Usual Dosage: See package insert for dosage and administration information. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Keep out of reach of children. Manufactured for Northstar Rx LLC, Memphis, TN 38141. Manufactured by MISN Laboratories Private Limited, 90 Tablets, Product of India. NDC 72603-259-01. Issued: 03/2024.*

FDA Label Image

Fig1 (Pirfenidone Figure 1)

The text provides numerical data representing the change in %FVC (Forced Vital Capacity) from baseline to week 52 in a study comparing the drug Pirfenidone with a placebo. It shows different percentage values and categories such as "Worsening" (Decrease in %FVC) and "No Decline" (Increase in %FVC) for the two groups (Pirfenidone and Placebo). The data is segmented into intervals like 10-30%, 30-40%, and 40-50% for the absolute change in %FVC.*

FDA Label Image

Fig2 (Pirfenidone Figure 2)

FDA Label Image

Fig3 (Pirfenidone Figure 3)

This text provides information on a study involving Pirlenidone (n=623) and Placebo (n=624) in terms of the percentage of patients alive over time. The Hazard Ratio (HR) with 95% confidence interval (CI) is presented as 0.75 (0.51 - 1.11) between the two groups. The data also includes a time plot showing the survival rate of patients for both Pirlenidone and Placebo groups over weeks. Additionally, it shows the number of patients at risk for each group at specific time points.*

FDA Label Image

Str (Pirfenidone Str)

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