Pirfenidone Tablet, Film Coated
Product Images NDC 70954-869

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Pirfenidone (NDC 70954-869). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Ani Pharmaceuticals, 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

Pirf-267mg (Pirf 267mg)

Label for Pirfenidone Tablets 267 mg film-coated oral tablets distributed by ANI Pharmaceuticals, Inc. The label includes dosage strength, storage instructions, quantity of 90 tablets, and barcode. It is marked Rx only.*

FDA Label Image

Pirf-801mg (Pirf 801mg)

Label for Pirfenidone Tablets 801 mg film-coated oral tablets. The label states the quantity as 90 tablets and indicates it is an Rx-only product. Distributed by ANI Pharmaceuticals, Inc., Baudette, MN. It includes storage instructions and a barcode, along with the issuance date of 10/2023.*

FDA Label Image

Pirf-carton (Pirf Carton)

Pirfenidone Tablets 267 mg film coated oral tablets packaging label from ANI Pharmaceuticals, Inc. The label shows the strength as 267 mg and indicates a package count of 270 tablets (3 bottles of 90 tablets each). It includes storage instructions and is marked Rx only for prescription use.*

FDA Label Image

Pirfenidone Figure 1 (Pirfenidone Figure1)

A cumulative distribution plot showing the percentage of patients versus absolute change in %FVC from baseline to week 52. The graph compares Pirfenidone (n=278) and Placebo (n=277) groups, illustrating changes in lung function with labels indicating percentages of patients experiencing worsening or no decline.*

FDA Label Image

Figure 11 (Pirfenidone Figure11)

A dosing schedule table for Pirfenidone Tablets 267 mg showing the number of tablets to be taken in the morning, afternoon, and evening over three time periods: days 1 to 7, days 8 to 14, and days 15 onward, with total pills per day increasing from 3 to 6 to 9.*

FDA Label Image

Figure 13 (Pirfenidone Figure13)

Dosing schedule table for Pirfenidone tablets 801 mg. It instructs taking one brown 801 mg pirfenidone tablet three times daily with meals (breakfast, lunch, and dinner) starting from day 15 onward, totaling three pills per day.*

FDA Label Image

Pirfenidone Figure 2 (Pirfenidone Figure2)

A line graph showing mean change in forced vital capacity (FVC) in mL over 52 weeks comparing Pirfenidone and placebo groups. The x-axis represents weeks (0, 13, 26, 39, 52), and the y-axis shows mean change in FVC. Pirfenidone group data is represented by a solid line, placebo by a dashed line, with both groups showing decline, but with the placebo group declining more sharply over time.*

FDA Label Image

Pirfenidone Figure 3 (Pirfenidone Figure3)

A survival curve chart comparing the percentage of patients alive over time (weeks) for Pirfenidone versus placebo. The chart shows lines representing Pirfenidone (n=623) and placebo (n=624) with corresponding patient risk numbers at different time points. A hazard ratio (HR) with 95% confidence interval is noted.*

FDA Label Image

Pirfenidone Chemical Structure (Pirfenidone Structure)

Chemical structure of pirfenidone showing its molecular framework with a pyridone ring and attached phenyl group, including a methyl substituent on the pyridone ring.*

* 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.