Pirfenidone Tablet, Film Coated
Product Images NDC 42385-925

View Photos of Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Pirfenidone (NDC 42385-925). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Laurus Labs Limited, 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 Figure 1 (Pirfenidone Figure1)

Pirfenidone Figure 1 (Pirfenidone Figure1)
This appears to be a statistical chart showing the percentage of patients who experienced worsening, no change or improvement in their forced vital capacity (FVC) as a result of taking Pirfenidone compared to a placebo. The chart also shows the absolute change in FVC percentage from baseline to 52 weeks.*
FDA Label Image

Package Label.principal Display Panel (801 mg)

Package Label.principal Display Panel (801 mg)
Each tablet contains 801mg of pirfenidone, manufactured by Laurus Generics Inc. The usual dosage information can be found in the package insert. It is recommended to store the tablets at a temperature range of 20°C to 25°C (68°F to 77°F), with excursions allowed between 15°C to 30°C (59°F to 86°F). This medication is prescription-only and should be kept out of reach of children. The NDC number is 42385-926-90 and the tablets come in a bottle of 90. The M.L number is provided as 16/VSP/AP/2015F & BICG.*
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Figure 11 (Pirfenidone Figure11)

Figure 11 (Pirfenidone Figure11)
This is a dosing schedule for Pirfenidone capsules and tablets with 267 mg strength. The schedule is divided into three weeks; for the first week, the patient should take three pills every morning, afternoon, and evening, with a total of nine pills per day. During the second week, the patient should take two pills in the morning and afternoon, and seven pills during dinner, for a total of eleven pills per day. For the third week and onwards, the patient should take three pills during breakfast, lunch, and dinner, for a total of nine pills per day.*
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Figure 12 (Pirfenidone Figure12)

Figure 12 (Pirfenidone Figure12)
This is a dosing schedule for Pirfenidone 534 mg tablets where 1 tablet should be taken three times a day, with one tablet during breakfast, lunch, and dinner. The table lists the dosage for days 8 to 14, indicating that a total of 3 pills should be taken each day, one in the morning, afternoon, and evening.*
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Figure 13 (Pirfenidone Figure13)

Figure 13 (Pirfenidone Figure13)
The text provides instructions on the dosing schedule for Pirfenidone Tablets of 801 mg. The recommended dose is one brown tablet three times a day. The dosing schedule is presented in a chart divided into morning, afternoon, and evening, for a total of three pills per day. The dosing schedule is followed from day 15 onward.*
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Pirfenidone Figure 2 (Pirfenidone Figure2)

FDA Label Image

Pirfenidone Figure 3 (Pirfenidone Figure3)

Pirfenidone Figure 3 (Pirfenidone Figure3)
This appears to be a table presenting survival data for patients treated with Pirfenidone compared to those treated with a placebo. The percentage of patients alive is shown for each group at different time points, along with the corresponding hazard ratio and patients at risk. However, without additional context, it is difficult to draw conclusions or provide more specific information.*
FDA Label Image

Package Label.principal Display Panel (267 mg)

Package Label.principal Display Panel (267 mg)
This is a medication called Pirfenidone in capsule form containing 267mg of the medication. It is important to refer to the package insert for information on the dosage and administration of this medication. It is recommended to store between 20°C to 25°C, with a limited range of excursions between 15°C to 30°C. It is advisable to keep the medication out of reach of children. The medcation was manufactured for Laurus Generics Inc, and Laurus Labs Limited in India. The lot number provided is not readable.*
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Package Label.principal Display Panel (14-Day Titration Pack)

Package Label.principal Display Panel (14-Day Titration Pack)
This is a description of a 14-day titration pack of Pirfenidone Capsules manufactured by Laurus Labs. The pack includes 21 capsules for week one and 42 capsules for week two. Each capsule contains 267 mg of Pirfenidone. The dosing instructions state to take one capsule three times a day for week one and two capsules three times a day for week two. The store temperature range is 20°C to 25°C, with excursions permitted between 15°C to 30°C. The not-for-resale pack is only for the patient's first two weeks of therapy, and patients should refer to the package insert for usual dosage and administration information. The National Drug Code (NDC) for the product is 42385-923-63, and the product is manufactured by Laurus Labs Limited. Keep out of reach of children.*
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Package Label.principal Display Panel (Maintenance Pack)

Package Label.principal Display Panel (Maintenance Pack)
The text describes the packaging and dosage information for Pirfenidone capsules from LAURUS Labs. Each carton contains 4 weekly packs of 252 capsules, with each weekly pack containing 63 capsules and each capsule containing 267 mg of pirfenidone. The recommended dosage and administration information is available in the package insert. The product should be stored at controlled room temperature and kept out of reach of children. The capsules are manufactured by Laurus Labs Limited in India and distributed by Laurus Generics Inc. in Berkeley Heights, NJ.*
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Package Label.principal Display Panel (267 mg)

Package Label.principal Display Panel (267 mg)
Each tablet of Pirfenidone contains 267mg of the drug. The usual dosage should be obtained from the package insert. Store the tablets between 20-25°C and do not exceed 30°C. Keep away from children. Manufacturing details and brand name are not provided.*
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Package Label.principal Display Panel (267 mg)

Package Label.principal Display Panel (267 mg)
This is a description of a medication called Pirfenidone in tablet form. It is kept out of reach of children and comes in a package of 270 tablets, which are divided into three bottles of 90 tablets each. Each film-coated tablet contains 267mg of Pirfenidone, and the package insert should be consulted for the medication's dosage and administration information. The medication should be stored at a temperature of 20° to 25°C (69°F to 77°F), with excursions permitted between 15°C to 30°C (59°F to 86°F). The medicine is manufactured by Launss Generics Inc., located at 40 Cone et, Suite 200, Barkely Heights, W 07522, and by Launss Labs Limited in Visakagatoan-531011.*
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Package Label.principal Display Panel (534 mg)

Package Label.principal Display Panel (534 mg)
Each tablet of Pirfenidone B contains 534mg of pirfenidone. Dosage information can be found in the package insert. The tablets should be stored between 20°C to 25°C, with excursions allowed between 15°C to 30°C. The product is manufactured by Laurus Labs Limited in India. The M.L No is 16VSP/AP/201S/F & B/CC, and the NDC is 42385-925-90. This product is only available with a prescription and should be kept out of reach of children.*
FDA Label Image

Pirfenidone Chemical Structure (Pirfenidone Structure)

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