Pirfenidone Tablet, Coated
Product Images NDC 71335-2984

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Pirfenidone (NDC 71335-2984). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Bryant Ranch Prepack, 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

Label (Lbl713352984)

This description provides details about a medication called Pirfenidone in tablet form. Each film-coated tablet contains 801 mg of Pirfenidone. The usual dosage information can be found by scanning the package insert QR code. The tablets should be stored at 25°C (77°F) with temperature excursions allowed from 15° to 30°C (59° to 86°F). The medication is for prescription use only and should be kept out of reach of children. The tablets come in a package containing 90 tablets. The medication is relabeled by Bryant Ranch Prepack, Inc. and manufactured by Alembic Pharmaceuticals Limited.*

FDA Label Image

Figure 1 (Pirfenidone Figure1)

This text provides data on the percentage of patients with worsening or no decline in Forced Vital Capacity (%FVC) after treatment with Pirfenidone or Placebo. It shows the absolute change in %FVC from baseline to week 52. The results indicate that Pirfenidone had a positive impact on %FVC compared to the Placebo group.*

FDA Label Image

Figure 2 (Pirfenidone Figure2)

The text provides information on the Mean Change in Forced Vital Capacity (FVC) in milliliters for two groups: Pijrfenidone with n=278 and Placebo with n=277 over a period of weeks. The data shows changes in FVC measurements for each week, ranging from -100 mL to -500 mL.*

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Figure 3 (Pirfenidone Figure3)

This is a statistical comparison between Pirfenidone and Placebo in terms of the percentage of patients alive. The data provides information on the Hazard Ratio (HR) with confidence interval, and the number of patients in each group at different time points up to 120 weeks. The analysis suggests that Pirfenidone may have a lower risk of mortality compared to Placebo, with a HR of 0.75.*

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Pirfenidone-pi-table1 (Pirfenidone Pi Table 1)

This text provides a dosing schedule for Pirfenidone Tablets 267 mg, indicating the number of tablets to be taken in the morning, afternoon, and evening for each week. It specifies the total number of pills to be consumed each day for days 1 to 7, days 8 to 14, and beyond day 15. This information is important for ensuring proper intake of the medication as prescribed.*

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Pirfenidone-pi-table-2 (Pirfenidone Pi Table 2)

This is a dosing schedule for Pirfenidone tablets of 801 mg, to be taken 1 tablet with breakfast, 1 tablet with lunch, and 1 tablet with dinner, totaling 3 pills per day starting from day 15 onwards.*

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Pirfenidone (Pirfenidone Structure)

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