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Pirfenidone 267 mg Tablet, Film Coated, 3-count — NDC 42571-0335-39 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Pirfenidone 267 mg Tablet, Film Coated, 3-count — NDC 42571-335-39 (Billing 42571-0335-39)

by Micro Labs Limited · 3 TABLET, FILM COATED in 1 CARTON

This is a package of 3 tablets of Pirfenidone 267 mg Tablet, Film Coated from Micro Labs Limited, marketed since Dec 2022 and currently FDA-listed; retail pharmacies pay about $0.6855 per tablet (NADAC). It is the main listing for this product, which comes in 2 package sizes.

NDC 42571-0335-39
🏷️ FDA NDC (as labeled) 42571-335-39 billing pads the product segment with a zero
This package
Contains3-count Cost per ea$0.6855 NADAC Per package$2.06 / 3 tablets Pack sizes2 compare ↓
Also priced by: Part D plans $24.12/unit — full pricing hub ↓
Main listing for product 42571-335 · Also comes in: 90 tablets 42571-335-90
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 42571-335-39
Product NDC 42571-335
11-digit billing NDC 42571033539
NCPDP billing unit EA — each (per item)
RxCUI 1868014, 1868018
UNII D7NLD2JX7U
UPC 0342571335908, 0342571336905, 0342571335397
Application # ANDA212680
SPL Set ID 1abc06c7-6a45-4a0b-b2da-c228aaa137ed
Established class (EPC) Pyridone
Chemical class Pyridones
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-12-01
Route ORAL
Dosage form TABLET, FILM COATED
Substance PIRFENIDONE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 45550060000325
GCN Seq No 077032
GCN 42903
HICL code 040237
Ingredient (HICL) Pirfenidone
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code Z1
Therapeutic class — intermediate (HIC2) Positive Effects On Wide-Spread Tissue
HIC3 code Z1M
Therapeutic class — specific (HIC3) Antifibrotic Therapy - Pyridone Analogs
AHFS code 48:02.00.00
AHFS class Antifibrotic Agents
FDB label name PIRFENIDONE 267 MG TABLET
FDB brand name Pirfenidone
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 077032
  • GCN: 42903
  • GPI-14 (Medi-Span): 45550060000325
  • HICL (First Databank): 040237
  • AHFS class code: 48:02.00.00
  • RxCUI (RxNorm): 1868014
Why two NDCs? The FDA registers this code as 42571-335-39 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 42571-0335-39. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Pyridone class.

Pharmacologic class Pyridone
Drug family (ATC) Other immunosuppressants
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name PIRFENIDONE 267 MG TABLET Ingredient Pirfenidone
📗 Our plain-language guide HelloPharmacist
  • It treats idiopathic pulmonary fibrosis, or IPF, a lung disease where scarring builds up for no known reason. Esbriet and generic pirfenidone capsules and tablets are all labeled f...
  • Take it by mouth three times a day with food, at about the same times each day. You’ll start low and build up over about 14 days. If you miss a dose, don’t double up, and never tak...
  • Nausea, rash, stomach pain, diarrhea, tiredness and decreased appetite are common. Stomach effects are usually worst in the first few months and often ease. Tell us if they get bot...
  • Yes. Pirfenidone can make your skin sensitive to sunlight. Avoid sun and sunlamps, wear sunscreen and cover up daily. Let your doctor know if you develop a rash.
📖 Read our full Pirfenidone guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.686 $2.06 / 3 tablets
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $24.12 $72.36 / 3 tablets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $1.516 $0.686
▼ Down 45% over the last 10 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
42571-0335-90 42571-335-90 90 BOTTLE in 1 CARTON / 90 TABLET, FILM COATED in 1 BOTTLE — — 2022-12-01 — Active
42571-0335-39 You're viewing this Main listing 3 TABLET, FILM COATED in 1 CARTON $0.6855 / ea $2.06 2022-12-01 — Active

Pack size FAQ

What quantity is in this package?
This is a 3-count package — 3 tablet, film coated in 1 carton.
What NDC number is used to bill for this package of Pirfenidone 267 mg Tablet, Film Coated?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Pirfenidone 267 mg 00480-3610-87 Teva 270 tablets $0.685 AB Availability likely —
Pirfenidone 267 mg 00781-8085-32 Sandoz 270 tablets $0.685 AB Availability likely —
Pirfenidone 267 mg 00904-7397-53 MAJOR 90 tablets $0.685 AB Availability likely —
Pirfenidone 267 mg 31722-0872-27 Camber 90 tablets $0.685 AB Availability likely —
Pirfenidone 267 mg 42385-0924-99 Laurus 90 tablets $0.685 AB Availability likely —
Pirfenidone 267 mgthis 42571-0335-39 Micro 3 tablets $0.685 AB Availability likely —
Pirfenidone 267 mg 59651-0238-27 Aurobindo 270 tablets $0.685 AB Availability likely —
Pirfenidone 267 mg 60219-1640-08 Amneal 90 tablets $0.685 AB Availability likely —
Pirfenidone 267 mg 60505-4681-07 Apotex 270 tablets $0.685 AB Availability likely —
Pirfenidone 267 mg 62332-0479-64 Alembic 90 tablets $0.685 AB Availability likely —
Pirfenidone 267 mg 72205-0181-26 Novadoz 90 tablets $0.685 AB Availability likely —
Pirfenidone 267 mg 72603-0258-03 Northstar 90 tablets $0.685 AB Availability likely —
Pirfenidone 267 mg 76282-0717-27 EXELAN 270 tablets $0.685 AB Availability likely —
Pirfenidone 267 mg 16729-0467-85 Accord 90 tablets — AB FDA listed —
Pirfenidone 267 mg 42291-0491-27 AvKARE 90 tablets — AB FDA listed —
Pirfenidone 267 mg 46708-0479-27 Alembic 270 tablets — AB FDA listed —
Pirfenidone 267 mg 50228-0442-10 ScieGen 1000 tablets — AB FDA listed —
Esbriet 267 mg 50242-0122-06 Genentech, 270 tablets — AB FDA listed —
Pirfenidone 267 mg 51407-0913-27 Golden 270 tablets — AB FDA listed —
Pirfenidone 267 mg 69097-0987-05 Cipla 90 tablets — AB FDA listed —
Pirfenidone 267 mg 69238-1640-08 Amneal 90 tablets — AB FDA listed —
Pirfenidone 267 mg 70954-0869-10 ANI 90 tablets — AB FDA listed —
Pirfenidone 267 mg 71335-2944-01 Bryant 90 tablets — AB FDA listed —
Pirfenidone 267 mg 72162-2465-02 Bryant 90 tablets — AB FDA listed —
Esbriet 267 mg 83107-0028-27 Legacy 270 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2022
On the market since
Dec 2022
📍
2026
Currently FDA-listed
4 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color yellow / brown
ShapeOval
ImprintP2
Size2 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerMicro Labs Limited
Application holderMICRO LABS LTD
FDA applicationANDA212680 (ANDA)
Labeler code42571
First marketedDec 2022
Product typeHuman Prescription Drug
Portfolio190 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Patient Medication Information 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 33 words ▾

1 INDICATIONS AND USAGE Pirfenidone tablet is indicated for the treatment of idiopathic pulmonary fibrosis (IPF). Pirfenidone tablet is a pyridone indicated for the treatment of idiopathic pulmonary fibrosis (IPF). ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Take with food. Recommended dosage: 801 mg three times daily (2403 mg/day). ( 2 ) Upon initiation of treatment, titrate to the full dosage of 2403 mg/day over a 14-day period as follows: Treatment days Dosage Days 1 through 7 267 mg three times daily (801 mg/day) Days 8 through 14 534 mg three times daily (1602 mg/day) Days 15 onward 801 mg three times daily (2403 mg/day) Consider temporary dosage reduction, treatment interruption, or discontinuation for management of adverse reactions.

( 2.3 , 5.1 , 5.2 , 5.3 , 5.4 ) Prior to treatment, conduct liver function tests. ( 2.1 )

2.1Testing Prior to Pirfenidone Tablet Administration Conduct liver function tests prior to initiating treatment with pirfenidone tablets [see Warnings and Precautions (5.1) ].

2.2Recommended Dosage The recommended daily maintenance dosage of pirfenidone tablet is 801 mg three times daily for a total of 2403 mg/day. Doses should be taken with food at the same time each day. Upon initiation of treatment, titrate to the full dosage of 2403 mg/day over a 14-day period as follows: Table 1.

Dosage Titration for Pirfenidone Tablets in Patients with IPF Treatment days Dosage Days 1 through 7 267 mg three times daily (801 mg/day) Days 8 through 14 534 mg three times daily (1602 mg/day) Days 15 onward 801 mg three times daily (2403 mg/day) Dosages above 2403 mg/day are not recommended for any patient. Patients should not take 2 doses at the same time to make up for a missed dose. Patients should not take more than 3 doses per day.

2.3Dosage Modifications due to Adverse Reactions Patients who miss 14 or more days of pirfenidone tablets should re-initiate treatment by undergoing the initial 2-week titration regimen up to the full maintenance dosage [see Dosage and Administration (2.2) ] . For treatment interruption of less than 14 days, the dosage prior to the interruption can be resumed. If patients experience significant adverse reactions (i.e., gastrointestinal, photosensitivity reaction or rash, severe cutaneous adverse reactions (SCAR)), consider temporary dosage reductions or interruptions of pirfenidone tablets to allow for resolution of symptoms.

If a SCAR is confirmed, permanently discontinue pirfenidone tablets [see Warnings and Precautions ( 5.1 , 5.2 , 5.3 , 5.4 )] . Dosage Modification due to Elevated Liver Enzymes Dosage modifications or interruptions may also be necessary when liver enzyme and bilirubin elevations are exhibited. For liver enzyme elevations, modify the dosage as follows: If a patient exhibits >3 but ≤5 × the upper limit of normal (ULN) ALT and/or AST without symptoms or hyperbilirubinemia after starting pirfenidone tablets therapy: Discontinue confounding medications, exclude other causes, and monitor the patient closely.

Repeat liver chemistry tests as clinically indicated. The full daily dosage may be maintained, if clinically appropriate, or reduced or interrupted (e.g., until liver chemistry tests are within normal limits) with subsequent re­-titration to the full dosage as tolerated. If a patient exhibits >3 but ≤5 × ULN ALT and/or AST accompanied by symptoms or hyperbilirubinemia: Permanently discontinue pirfenidone tablets.

Do not rechallenge patient with pirfenidone tablets. If a patient exhibits >5 × ULN ALT and/or AST: Permanently discontinue pirfenidone tablets. Do not rechallenge patient with pirfenidone tablets.

2.4Dosage Modifications due to Drug Interactions Strong CYP1A2 Inhibitors (e.g., fluvoxamine, enoxacin) Reduce pirfenidone tablets to 267 mg three times a day (801 mg/day). Moderate CYP1A2 Inhibitors (e.g., ciprofloxacin) With use of ciprofloxacin at a dosage of 750 mg twice daily, reduce pirfenidone tablets to 534 mg three times a day (1602 mg/day).

💊 Dosage Forms and Strengths 65 words ▾

3 DOSAGE FORMS AND STRENGTHS Pirfenidone Tablets 267 mg are Yellow to pale yellow colored, oval shaped, biconvex film coated tablets plain on one side and debossed with 'P1' on the other side. Pirfenidone Tablets 801 mg are brown colored, oval shaped film coated tablets plain on one side and debossed with 'P2' on the other side. Tablets: 267 mg, 801 mg ( 3 )

⛔ Contraindications 4 words ▾

4 CONTRAINDICATIONS None. None

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Elevated liver enzymes and drug-induced liver injury: ALT, AST, and bilirubin elevations have occurred with pirfenidone tablets including cases of drug-induced liver injury. In the postmarketing setting, non-serious and serious cases of drug-induced liver injury, including severe liver injury with fatal outcomes, have been reported. Monitor ALT, AST, and bilirubin before and during treatment.

Temporary dosage reductions or discontinuations may be required. ( 2.1 , 5.1 ) Photosensitivity and rash: Photosensitivity and rash have been noted with pirfenidone tablets. Avoid exposure to sunlight and sunlamps.

Wear sunscreen and protective clothing daily. Temporary dosage reductions or discontinuations may be required. ( 5.2 ) Severe Cutaneous Adverse Reactions (SCAR): Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reactions with eosinophilia and systemic symptoms (DRESS) have been reported in association with the use of pirfenidone tablets in the postmarketing setting.

Interrupt pirfenidone tablets in case of signs or symptoms of SCAR. Permanently discontinue pirfenidone tablets if a SCAR is confirmed. ( 5.3 ) Gastrointestinal disorders: Nausea, vomiting, diarrhea, dyspepsia, gastro-esophageal reflux disease, and abdominal pain have occurred with pirfenidone tablets.

Temporary dosage reductions or discontinuations may be required. (5.4)

5.1Elevated Liver Enzymes and Drug-Induced Liver Injury Cases of drug-induced liver injury (DILI) have been observed with pirfenidone tablets. In the postmarketing period, non-serious and serious cases of DILI, including severe liver injury with fatal outcome, have been reported. Patients treated with pirfenidone tablets 2403 mg/day in three Phase 3 trials had a higher incidence of elevations in ALT or AST ≥3 × ULN than placebo patients (3.7% vs 0.8%, respectively).

Elevations ≥10 × ULN in ALT or AST occurred in 0.3% of patients in the pirfenidone tablets 2403 mg/day group and in 0.2% of patients in the placebo group. Increases in ALT and AST ≥3 × ULN were reversible with dose modification or treatment discontinuation. Conduct liver function tests (ALT, AST, and bilirubin) prior to the initiation of therapy with pirfenidone tablets, monthly for the first 6 months, every 3 months thereafter, and as clinically indicated.

Measure liver function tests promptly in patients who report symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice. Dosage modification or interruption may be necessary for liver enzyme elevations [see Dosage and Administration ( 2.1 , 2.3 )].

5.2Photosensitivity Reaction or Rash Patients treated with pirfenidone tablets 2403 mg/day in the three Phase 3 studies had a higher incidence of photosensitivity reactions (9%) compared with patients treated with placebo (1%). The majority of the photosensitivity reactions occurred during the initial 6 months. Instruct patients to avoid or minimize exposure to sunlight (including sunlamps), to use a sunblock (SPF 50 or higher), and to wear clothing that protects against sun exposure.

Additionally, instruct patients to avoid concomitant medications known to cause photosensitivity. Dosage reduction or discontinuation may be necessary in some cases of photosensitivity reaction or rash [see Dosage and Administration (2.3) ] .

5.3Severe Cutaneous Adverse Reactions Severe cutaneous adverse reactions (SCAR), including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with the use of pirfenidone tablets in the postmarketing setting. If signs or symptoms of SCAR occur, interrupt pirfenidone tablets treatment until the etiology of the reaction has been determined. Consultation with a dermatologist is recommended.

If a SCAR is confirmed, permanently discontinue pirfenidone tablets.

5.4Gastrointestinal Disorders… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: Liver Enzyme Elevations and Drug-Induced Liver Injury [see Warnings and Precautions ( 5.1 )] Photosensitivity Reaction or Rash [see Warnings and Precautions ( 5.2 )] Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.3 )] Gastrointestinal Disorders [see Warnings and Precautions ( 5.4 )] The most common adverse reactions (≥10%) are nausea, rash, abdominal pain, upper respiratory tract infection, diarrhea, fatigue, headache, decreased appetite, dyspepsia, dizziness, vomiting, gastro-esophageal reflux disease, sinusitis, insomnia, weight decreased, and arthralgia.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Micro Labs USA Inc. at 1-855-839-8195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of pirfenidone has been evaluated in more than 1400 subjects with over 170 subjects exposed to pirfenidone for more than 5 years in clinical trials. Pirfenidone tablets was studied in 3 randomized, double-blind, placebo-controlled trials (Studies 1, 2, and 3) in which a total of 623 patients received 2403 mg/day of pirfenidone tablets and 624 patients received placebo.

Subjects ages ranged from 40 to 80 years (mean age of 67 years). Most patients were male (74%) and Caucasian (95%). The mean duration of exposure to pirfenidone tablets was 62 weeks (range: 2 to 118 weeks) in these 3 trials.

At the recommended dosage of 2403 mg/day, 14.6% of patients on pirfenidone tablets compared to 9.6% on placebo permanently discontinued treatment because of an adverse event. The most common (>1%) adverse reactions leading to discontinuation were rash and nausea. The most common (>3%) adverse reactions leading to dosage reduction or interruption were rash, nausea, diarrhea, and photosensitivity reaction.

The most common adverse reactions with an incidence of ≥10% and more frequent in the pirfenidone tablets than placebo treatment group are listed in Table 2. Table 2. Adverse Reactions Occurring in ≥10% of Pirfenidone Tablets-Treated Patients and More Commonly Than Placebo in Studies 1, 2, and 3 Adverse Reaction % of Patients (0 to 118 Weeks) Pirfenidone Tablets 2403 mg/day (N = 623) Placebo (N = 624) Nausea 36% 16% Rash 30% 10% Abdominal Pain 1 24% 15% Upper Respiratory Tract Infection 27% 25% Diarrhea 26% 20% Fatigue 26% 19% Headache 22% 19% Decreased Appetite 21% 8% Dyspepsia 19% 7% Dizziness 18% 11% Vomiting 13% 6% Gastro-esophageal Reflux Disease 11% 7% Sinusitis 11% 10% Insomnia 10% 7% Weight Decreased 10% 5% Arthralgia 10% 7% 1 Includes abdominal pain, upper abdominal pain, abdominal distension, and stomach discomfort.

Adverse reactions occurring in ≥5 to <10% of pirfenidone tablets-treated patients and more commonly than placebo are photosensitivity reaction (9% vs. 1%), pruritus (8% vs. 5%), asthenia (6% vs.

4%), dysgeusia (6% vs. 2%), and non-cardiac chest pain (5% vs. 4%).

6.2Postmarketing Experience In addition to adverse reactions identified from clinical trials the following adverse reactions have been identified during post-approval use of pirfenidone. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency. Blood and Lymphatic System Disorders: Agranulocytosis Hepatobiliary Disorders: Drug-induced liver injury Immune System Disorders: Angioedema Skin and Subcutaneous Tissue Disorders: Severe Cutaneous Adverse Reactions (SCAR)

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Moderate (e.g., ciprofloxacin) and strong inhibitors of CYP1A2 (e.g., fluvoxamine) increase systemic exposure of pirfenidone tablet and may alter the adverse reaction profile of pirfenidone tablet. Discontinue fluvoxamine prior to administration of pirfenidone tablet or reduce to 267 mg three times a day. Consider dosage reduction with use of ciprofloxacin. ( 7.1 )

7.1CYP1A2 Inhibitors Pirfenidone is metabolized primarily (70 to 80%) via CYP1A2 with minor contributions from other CYP isoenzymes including CYP2C9, 2C19, 2D6 and 2E1. Strong CYP1A2 Inhibitors The concomitant administration of pirfenidone tablets and fluvoxamine or other strong CYP1A2 inhibitors (e.g., enoxacin) is not recommended because it significantly increases exposure to pirfenidone tablets [see Clinical Pharmacology (12.3) ]. Use of fluvoxamine or other strong CYP1A2 inhibitors should be discontinued prior to administration of pirfenidone tablets and avoided during pirfenidone tablets treatment.

In the event that fluvoxamine or other strong CYP1A2 inhibitors are the only drug of choice, dosage reductions are recommended. Monitor for adverse reactions and consider discontinuation of pirfenidone tablets as needed [ see Dosage and Administration (2.4) ] . Moderate CYP1A2 Inhibitors Concomitant administration of pirfenidone tablets and ciprofloxacin (a moderate inhibitor of CYP1A2) moderately increases exposure to pirfenidone tablets [see Clinical Pharmacology (12.3) ] .

If ciprofloxacin at the dosage of 750 mg twice daily cannot be avoided, dosage reductions are recommended [see Dosage and Administration (2.4) ]. Monitor patients closely when ciprofloxacin is used at a dosage of 250 mg or 500 mg once daily. Concomitant CYP1A2 and other CYP Inhibitors Agents or combinations of agents that are moderate or strong inhibitors of both CYP1A2 and one or more other CYP isoenzymes involved in the metabolism of pirfenidone tablets (i.e., CYP2C9, 2C19, 2D6, and 2E1) should be discontinued prior to and avoided during pirfenidone tablets treatment.

7.2CYP1A2 Inducers The concomitant use of pirfenidone tablets and a CYP1A2 inducer may decrease the exposure of pirfenidone tablets and this may lead to loss of efficacy. Therefore, discontinue use of strong CYP1A2 inducers prior to pirfenidone tablets treatment and avoid the concomitant use of pirfenidone tablets and a strong CYP1A2 inducer [see Clinical Pharmacology (12.3) ] .

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Hepatic Impairment: Monitor for adverse reactions and consider dosage modification or discontinuation of pirfenidone tablet as needed. Pirfenidone tablets are not recommended for use in patients with severe hepatic impairment. ( 8.6 , 12.3 ) Renal Impairment: Monitor for adverse reactions and consider dosage modification or discontinuation of pirfenidone tablets as needed.

Pirfenidone tablets are not recommended for use in patients with end stage renal disease on dialysis. ( 8.7 , 12.3 ) Smokers: Decreased exposure has been noted in smokers which may alter the efficacy profile of pirfenidone tablets. ( 8.8 )

8.1Pregnancy Risk Summary The data with pirfenidone tablets use in pregnant women are insufficient to inform on drug associated risks for major birth defects and miscarriage. In animal reproduction studies, pirfenidone was not teratogenic in rats and rabbits at oral doses up to 3 and 2 times, respectively, the maximum recommended daily dose (MRDD) in adults [see Data] . In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Data Animal Data Animal reproductive studies were conducted in rats and rabbits. In a combined fertility and embryofetal development study, female rats received pirfenidone at oral doses of 0, 50, 150, 450, and 1000 mg/kg/day from 2 weeks prior to mating, during the mating phase, and throughout the periods of early embryonic development from gestation days (GD) 0 to 5 and organogenesis from GD 6 to 17. In an embryofetal development study, pregnant rabbits received pirfenidone at oral doses of 0, 30, 100, and 300 mg/kg/day throughout the period of organogenesis from GD 6 to 18.

In these studies, pirfenidone at doses up to 3 and 2 times, respectively, the maximum recommended daily dose (MRDD) in adults (on mg/m 2 basis at maternal oral doses up to 1000 mg/kg/day in rats and 300 mg/kg/day in rabbits, respectively) revealed no evidence of impaired fertility or harm to the fetus due to pirfenidone. In the presence of maternal toxicity, acyclic/irregular cycles (e.g., prolonged estrous cycle) were seen in rats at doses approximately equal to and higher than the MRDD in adults (on a mg/m 2 basis at maternal doses of 450 mg/kg/day and higher).

In a pre- and post-natal development study, female rats received pirfenidone at oral doses of 0, 100, 300, and 1000 mg/kg/day from GD 7 to lactation day 20. Prolongation of the gestation period, decreased numbers of live newborn, and reduced pup viability and body weights were seen in rats at an oral dosage approximately 3 times the MRDD in adults (on a mg/m 2 basis at a maternal oral dose of 1000 mg/kg/day).

8.2Lactation Risk Summary No information is available on the presence of pirfenidone in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. The lack of clinical data during lactation precludes clear determination of the risk of pirfenidone tablets to an infant during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for pirfenidone tablets and the potential adverse effects on the breastfed child from pirfenidone tablets or from the underlying maternal condition.

Data Animal Data: A study with radio-labeled pirfenidone in rats has shown that pirfenidone or its metabolites are excreted in milk. There are no data on the presence of pirfenidone or its metabolites in human milk, the effects of pirfenidone on the breastfed child, or its effects on milk production.

8.4Pediatric Use Safety and effectiveness of pirfenidone tablets in pediatric patients have not been established.

8.5Geriatric Use Of the total number of subjects in the clinical studies receiving pirfenidone tablets, 714 (67%) were 65 years old and over, while 231 (22%) were 75 years old and over. No overall difference… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary The data with pirfenidone tablets use in pregnant women are insufficient to inform on drug associated risks for major birth defects and miscarriage. In animal reproduction studies, pirfenidone was not teratogenic in rats and rabbits at oral doses up to 3 and 2 times, respectively, the maximum recommended daily dose (MRDD) in adults [see Data] . In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Data Animal Data Animal reproductive studies were conducted in rats and rabbits. In a combined fertility and embryofetal development study, female rats received pirfenidone at oral doses of 0, 50, 150, 450, and 1000 mg/kg/day from 2 weeks prior to mating, during the mating phase, and throughout the periods of early embryonic development from gestation days (GD) 0 to 5 and organogenesis from GD 6 to 17. In an embryofetal development study, pregnant rabbits received pirfenidone at oral doses of 0, 30, 100, and 300 mg/kg/day throughout the period of organogenesis from GD 6 to 18.

In these studies, pirfenidone at doses up to 3 and 2 times, respectively, the maximum recommended daily dose (MRDD) in adults (on mg/m 2 basis at maternal oral doses up to 1000 mg/kg/day in rats and 300 mg/kg/day in rabbits, respectively) revealed no evidence of impaired fertility or harm to the fetus due to pirfenidone. In the presence of maternal toxicity, acyclic/irregular cycles (e.g., prolonged estrous cycle) were seen in rats at doses approximately equal to and higher than the MRDD in adults (on a mg/m 2 basis at maternal doses of 450 mg/kg/day and higher).

In a pre- and post-natal development study, female rats received pirfenidone at oral doses of 0, 100, 300, and 1000 mg/kg/day from GD 7 to lactation day 20. Prolongation of the gestation period, decreased numbers of live newborn, and reduced pup viability and body weights were seen in rats at an oral dosage approximately 3 times the MRDD in adults (on a mg/m 2 basis at a maternal oral dose of 1000 mg/kg/day).

🧒 Pediatric Use 16 words ▾

8.4Pediatric Use Safety and effectiveness of pirfenidone tablets in pediatric patients have not been established.

🧓 Geriatric Use 55 words ▾

8.5Geriatric Use Of the total number of subjects in the clinical studies receiving pirfenidone tablets, 714 (67%) were 65 years old and over, while 231 (22%) were 75 years old and over. No overall differences in safety or effectiveness were observed between older and younger patients. No dosage adjustment is required based upon age.

🆘 Overdosage 72 words ▾

10 OVERDOSAGE There is limited clinical experience with overdosage. Multiple dosages of pirfenidone tablets up to a maximum tolerated dose of 4005 mg per day were administered as five 267 mg capsules three times daily to healthy adult volunteers over a 12-day dose escalation. In the event of a suspected overdosage, appropriate supportive medical care should be provided, including monitoring of vital signs and observation of the clinical status of the patient.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The mechanism of action of pirfenidone in the treatment of IPF has not been established.

12.2Pharmacodynamics Cardiac Electrophysiology: The effect of pirfenidone tablets on QT interval was evaluated in a randomized, placebo, and positive controlled parallel study in 160 healthy adult volunteers. Volunteers received pirfenidone tablets 2403 mg/day (recommended dose) and 4005 mg/day (1.6 times recommended dose) or placebo for 10 days or a single dose of 400 mg moxifloxacin (active control). Relative to placebo, the maximum mean change from baseline in study-specific QT interval was 3.2 milliseconds (ms) and 2.2 ms for pirfenidone tablets 2403 mg/day and 4005 mg/day, respectively.

No volunteer had a QTc interval greater than 480 ms or change from baseline greater than 60 ms. Although there was no evidence that pirfenidone tablets prolonged the QTc interval in this study, a definitive conclusion may not be drawn as the positive control (moxifloxacin) did not perform as expected in this study, and pirfenidone tablets at 4005 mg/day (1.7 times the maximum recommended dose) did not cover the maximum pirfenidone exposure increase with co-administration of fluvoxamine, a strong CYP1A2 inhibitor.

12.3Pharmacokinetics Absorption: After single oral-dose administration of 801 mg pirfenidone (three 267 mg capsules), the maximum observed plasma concentration (C max ) was achieved between 30 minutes and 4 hours (median time of 0.5 hours). Food decreased the rate and extent of absorption. Median T max increased from 0.5 hours to 3 hours with food.

Maximum plasma concentrations (C max ) and AUC 0 to inf decreased by approximately 49% and 16% with food, respectively. Bioequivalence was demonstrated in the fasted state when comparing the 801 mg tablet to three 267 mg capsules. The effect of food on pirfenidone exposure was consistent between the tablet and capsule formulations.

A reduced incidence of adverse reactions was observed in the fed group when compared to the fasted group. In controlled studies with IPF patients, pirfenidone tablets was taken with food [see Dosage and Administration (2) and Clinical Studies (14) ] . The absolute bioavailability of pirfenidone has not been determined in humans.

Distribution: Pirfenidone binds to human plasma proteins, primarily to serum albumin, in a concentration- independent manner over the range of concentrations observed in clinical trials. The overall mean binding was 58% at concentrations observed in clinical studies (1 to 10 mcg/mL). Mean apparent oral volume of distribution is approximately 59 to 71 liters.

Metabolism: In vitro profiling studies in hepatocytes and liver microsomes have shown that pirfenidone is primarily metabolized in the liver by CYP1A2 and multiple other CYPs (CYP2C9, 2C19, 2D6, and 2E1). Oral administration of pirfenidone tablets results in the formation of four metabolites. In humans, only pirfenidone and 5-carboxy-pirfenidone are present in plasma in significant quantities.

The mean metabolite-to-parent ratio ranged from approximately 0.6 to 0.7. No formal radiolabeled studies have assessed the metabolism of pirfenidone in humans. In vitro data suggests that metabolites are not expected to be pharmacologically active at observed metabolite concentrations.

Elimination: The mean terminal half-life is approximately 3 hours in healthy subjects. Pirfenidone is excreted predominantly as metabolite 5-carboxy-pirfenidone, mainly in the urine (approximately 80% of the dose). The majority of pirfenidone was excreted as the 5-carboxy metabolite (approximately 99.6% of that recovered).

Specific Populations: Hepatic Impairment The pharmacokinetics of pirfenidone and the 5-carboxy-pirfenidone metabolite were studied in 12 subjects with moderate hepatic impairment (Child Pugh Class B) and in 12 subjects with normal hepatic function. Results showed that the mean exposure, AUC 0 to inf and C max of pirfenidone increased approximately 1.6-… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 19 words ▾

12.1Mechanism of Action The mechanism of action of pirfenidone in the treatment of IPF has not been established.

📦 How Supplied / Storage and Handling 136 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Pirfenidone Tablets 267 mg are Yellow to pale yellow colored, oval shaped, biconvex film coated tablets plain on one side and debossed with 'P1' on the other side. 90’s Count Bottle in a Carton: NDC 42571-335-90 Carton of 270 (3 bottles of 90 tablets each): NDC 42571-335-39 Pirfenidone Tablets 801 mg are brown colored, oval shaped film coated tablets plain on one side and debossed with 'P2' on the other side. 90’s Count Bottle in a Carton: NDC 42571-336-90 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Keep the bottle tightly closed. Do not use if the seal over the bottle opening is broken or missing. Safely throw away any pirfenidone tablet that is out of date or no longer needed.

📋 Description 144 words ▾

11 DESCRIPTION Pirfenidone tablets belong to the chemical class of pyridone. Pirfenidone tablets are available as film-coated tablets containing 267 mg (yellow) and 801 mg (brown) pirfenidone. Pirfenidone has a molecular formula of C 12 H 11 NO and a molecular weight of 185.23.

Pirfenidone has the following structural formula, which has been referred to as 5-methyl-1­-phenyl-2-1(H)-pyridone or 5-methyl-1-phenyl-2-(1H)-pyridone. Pirfenidone is a white to pale yellow crystalline powder. It is freely soluble in ethanol (96%), sparing soluble in water and very slightly soluble in heptane.

The melting point is approximately 110.1°C to 110.2°C. Pirfenidone tablets contain pirfenidone and the following inactive ingredients: colloidal silicon dioxide, dibasic calcium phosphate dihydrate, sodium starch glycolate type A, polysorbate 80, maize starch B, sodium stearyl fumarate, polyvinyl alcohol, polyethylene glycol 3350, ferrosoferric oxide, iron oxide yellow (267 mg), iron oxide red (801 mg), talc and titanium dioxide. Structure

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Liver Enzyme Elevations Advise patients that they may be required to undergo liver function testing periodically. Instruct patients to immediately report any symptoms of a liver problem (e.g., skin or the white of eyes turn yellow, urine turns dark or brown [tea colored], pain on the right side of stomach, bleed or bruise more easily than normal, lethargy) [see Warnings and Precautions ( 5.1 )] .

Photosensitivity Reaction or Rash Advise patients to avoid or minimize exposure to sunlight (including sunlamps) during use of pirfenidone tablets because of concern for photosensitivity reactions or rash. Instruct patients to use a sunblock and to wear clothing that protects against sun exposure. Instruct patients to report symptoms of photosensitivity reaction or rash to their physician.

Temporary dosage reductions or discontinuations may be required [see Warnings and Precautions ( 5.2 )] . Severe Cutaneous Adverse Reactions Advise patients about signs and symptoms of severe cutaneous adverse reactions (SCAR). Advise patients to contact their healthcare provider immediately if they experience signs and symptoms of SCAR [see Warnings and Precautions ( 5.3 )].

Gastrointestinal Events Instruct patients to report symptoms of persistent gastrointestinal effects including nausea, diarrhea, dyspepsia, vomiting, gastro-esophageal reflux disease, and abdominal pain. Temporary dosage reductions or discontinuations may be required [see Warnings and Precautions (5.4) ]. Smokers Encourage patients to stop smoking prior to treatment with pirfenidone tablets and to avoid smoking when using pirfenidone tablets [see Clinical Pharmacology (12.3) ] .

Take with Food Instruct patients to take pirfenidone tablets with food to help decrease nausea and dizziness. Manufactured by: Micro Labs Limited INDIA. Manufactured for: Micro Labs USA, Inc.

Somerset, NJ 08873 Rev. 02/2025

💬 Patient Medication Information ~3 min read ▾

Patient Information Pirfenidone ( pir fen’ i done) Tablets What are pirfenidone tablets? Pirfenidone tablets are a prescription medicine used to treat people with a lung disease called idiopathic pulmonary fibrosis (IPF). It is not known if pirfenidone tablets are safe and effective in children.

Before you take pirfenidone tablets, tell your doctor about all of your medical conditions, including if you: have liver problems have kidney problems are a smoker are pregnant or plan to become pregnant. It is not known if pirfenidone tablets will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if pirfenidone passes into your breast milk.

You and your doctor should decide if you will take pirfenidone tablets. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. How should I take pirfenidone tablets?

Take pirfenidone tablets exactly as your doctor tells you to take it. Your doctor may change your dose of pirfenidone tablets as needed. Take pirfenidone tablets with food at the same time each day.

This may help to decrease your nausea and dizziness. Pirfenidone tablets 267 mg is supplied as a yellow tablet. If you have been prescribed pirfenidone tablets 267 mg, take it as follows: Take 1 pirfenidone tablets 267 mg tablet 3 times each day for days 1 through 7.

Take 2 pirfenidone tablets 267 mg tablet 3 times each day for days 8 through 14. Take 3 pirfenidone tablets 267 mg tablet 3 times each day on day 15 and each day after. Pirfenidone Tablets 267 mg Dosing Schedule Week Morning (Breakfast) Afternoon (Lunch) Evening (Dinner) Total Pills Each Day Days 1 to 7 1 1 1 3 Days 8 to 14 2 2 2 6 Days 15 onward 3 3 3 9 If you have been prescribed the brown 801 mg pirfenidone tablets film-coated tablets, take it as follows: Take 1 brown 801 mg pirfenidone tablet 3 times each day.

Pirfenidone Tablets 801 mg Dosing Schedule Week Morning (Breakfast) Afternoon (Lunch) Evening (Dinner) Total Pills Each Day Days 15 onward 1 1 1 3 If you miss 14 days or more of pirfenidone tablets call your doctor right away for further instructions about how to take your medicine. Do not take 2 doses at the same time to make up for your missed dose. Do not take more than 3 doses each day.

If you take too much pirfenidone tablets, call your doctor or go to the nearest hospital emergency room right away. Your doctor should do certain blood tests before you start taking pirfenidone tablets. What should I avoid while taking pirfenidone tablets ?

Avoid sunlight. Pirfenidone tablets can make your skin sensitive to the sun and the light from sunlamps and tanning beds. You could get a severe sunburn.

Use sunscreen (SPF 50) and wear a hat and clothes that cover your skin if you have to be in sunlight. Talk to your doctor if you get sunburn or a rash. Avoid taking pirfenidone tablets with other medicines that can make your skin sensitive to the sun, the light from sunlamps and tanning beds.

Avoid smoking. Smoking may affect how well pirfenidone tablets works. What are the possible side effects of pirfenidone tablets?

Pirfenidone tablets may cause serious side effects, including: liver problems. Call your doctor right away if you have unexplained symptoms such as yellowing of your skin or the white part of your eyes (jaundice), dark or brown (tea colored) urine, pain on the upper right side of your stomach area (abdomen), bleeding or bruising more easily than normal, feeling tired. Your doctor will do blood tests to check how your liver is working during your treatment with pirfenidone tablets. sensitivity to sunlight (photosensitivity) and rash.

See “What should I avoid while taking pirfenidone tablets?” severe skin reactions. Call your doctor right away if you have a severe skin reaction such as skin blisters, rash, sores in the mouth, hives or any other severe skin symptoms. Your doctor may stop your treatment with pirfenidone tablet. stomach problems.

Pirfenid… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Absorption: After single oral-dose administration of 801 mg pirfenidone (three 267 mg capsules), the maximum observed plasma concentration (C max ) was achieved between 30 minutes and 4 hours (median time of 0.5 hours). Food decreased the rate and extent of absorption. Median T max increased from 0.5 hours to 3 hours with food.

Maximum plasma concentrations (C max ) and AUC 0 to inf decreased by approximately 49% and 16% with food, respectively. Bioequivalence was demonstrated in the fasted state when comparing the 801 mg tablet to three 267 mg capsules. The effect of food on pirfenidone exposure was consistent between the tablet and capsule formulations.

A reduced incidence of adverse reactions was observed in the fed group when compared to the fasted group. In controlled studies with IPF patients, pirfenidone tablets was taken with food [see Dosage and Administration (2) and Clinical Studies (14) ] . The absolute bioavailability of pirfenidone has not been determined in humans.

Distribution: Pirfenidone binds to human plasma proteins, primarily to serum albumin, in a concentration- independent manner over the range of concentrations observed in clinical trials. The overall mean binding was 58% at concentrations observed in clinical studies (1 to 10 mcg/mL). Mean apparent oral volume of distribution is approximately 59 to 71 liters.

Metabolism: In vitro profiling studies in hepatocytes and liver microsomes have shown that pirfenidone is primarily metabolized in the liver by CYP1A2 and multiple other CYPs (CYP2C9, 2C19, 2D6, and 2E1). Oral administration of pirfenidone tablets results in the formation of four metabolites. In humans, only pirfenidone and 5-carboxy-pirfenidone are present in plasma in significant quantities.

The mean metabolite-to-parent ratio ranged from approximately 0.6 to 0.7. No formal radiolabeled studies have assessed the metabolism of pirfenidone in humans. In vitro data suggests that metabolites are not expected to be pharmacologically active at observed metabolite concentrations.

Elimination: The mean terminal half-life is approximately 3 hours in healthy subjects. Pirfenidone is excreted predominantly as metabolite 5-carboxy-pirfenidone, mainly in the urine (approximately 80% of the dose). The majority of pirfenidone was excreted as the 5-carboxy metabolite (approximately 99.6% of that recovered).

Specific Populations: Hepatic Impairment The pharmacokinetics of pirfenidone and the 5-carboxy-pirfenidone metabolite were studied in 12 subjects with moderate hepatic impairment (Child Pugh Class B) and in 12 subjects with normal hepatic function. Results showed that the mean exposure, AUC 0 to inf and C max of pirfenidone increased approximately 1.6- and approximately 1.4-fold in subjects with moderate hepatic impairment, respectively. The exposure of 5-carboxy-pirfenidone did not change significantly in subjects with moderate hepatic impairment.

Renal Impairment The pharmacokinetics of pirfenidone and the 5-carboxy-pirfenidone metabolite were studied in 18 subjects with mild (CL cr 50 to 80 mL/min), moderate (CL cr 30 to 50 mL/min), and severe (CL cr less than 30 mL/min) renal impairment (n=6/group) and in 6 subjects with normal CL cr (greater than or equal to 80 mL/min) renal function. Results showed that systemic exposure (AUC 0 to inf ) to pirfenidone increased approximately 1.4, 1.5, and 1.2-fold in subjects with mild, moderate and severe renal impairment, respectively.

The corresponding AUC 0 to inf of 5-carboxy-pirfenidone increased 1.7, 3.4, and 5.6-fold, although the change in the patients with mild renal impairment was not statistically significant. The renal clearance of 5-carboxy-pirfenidone decreased significantly in patients with moderate to severe renal impairment. The pharmacokinetics and safety of pirfenidone tablets has not been studied in subjects with end- stage renal disease requiring dialysis.

Geriatric Results of population pharmacokinetic analysis suggest that… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 168 words ▾

12.2Pharmacodynamics Cardiac Electrophysiology: The effect of pirfenidone tablets on QT interval was evaluated in a randomized, placebo, and positive controlled parallel study in 160 healthy adult volunteers. Volunteers received pirfenidone tablets 2403 mg/day (recommended dose) and 4005 mg/day (1.6 times recommended dose) or placebo for 10 days or a single dose of 400 mg moxifloxacin (active control). Relative to placebo, the maximum mean change from baseline in study-specific QT interval was 3.2 milliseconds (ms) and 2.2 ms for pirfenidone tablets 2403 mg/day and 4005 mg/day, respectively.

No volunteer had a QTc interval greater than 480 ms or change from baseline greater than 60 ms. Although there was no evidence that pirfenidone tablets prolonged the QTc interval in this study, a definitive conclusion may not be drawn as the positive control (moxifloxacin) did not perform as expected in this study, and pirfenidone tablets at 4005 mg/day (1.7 times the maximum recommended dose) did not cover the maximum pirfenidone exposure increase with co-administration of fluvoxamine, a strong CYP1A2 inhibitor.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES The efficacy of pirfenidone tablets was evaluated in patients with IPF in three phase 3, randomized, double-blind, placebo-controlled, multicenter trials (Studies 1, 2, and 3). Study 1 was a 52-week trial comparing pirfenidone tablets 2403 mg/day (n=278) versus placebo (n=277) in patients with IPF. Study 2 and Study 3 were nearly identical to each other in design, with few exceptions, including an intermediate dose treatment arm in Study 2.

Study 2 compared treatment with either pirfenidone tablets 2403 mg/day (n=174) or pirfenidone tablets 1197 mg/day (n=87) to placebo (n=174), while Study 3 compared pirfenidone tablets 2403 mg/day (n=171) to placebo (n=173). Study drug was administered three times daily with food for a minimum of 72 weeks. Patients continued on treatment until the last patient completed 72 weeks of treatment, which included observations to approximately 120 weeks of study treatment.

The primary endpoint was the change in percent predicted forced vital capacity (%FVC) from baseline to study end, measured at 52 weeks in Study 1, and at 72 weeks in Studies 2 and 3. Studies 1, 2 and 3 enrolled adult patients who had a clinical and radiographic diagnosis of IPF (with or without accompanying surgical lung biopsy), without evidence or suspicion of an alternative diagnosis for interstitial lung disease. Eligible patients were to have %FVC greater than or equal to 50% at baseline and a percent predicted diffusing capacity of the lungs for carbon monoxide (%DL CO ) greater than or equal to 30% (Study 1) or 35% (Studies 2 and 3) at baseline.

In all three trials, over 80% of patients completed study treatment. A total of 1247 patients with IPF were randomized to receive pirfenidone tablets 2403 mg/day (n=623) or placebo (n=624) in these three trials. Baseline characteristics were generally balanced across treatment groups.

The study population ranged from 40 to 80 years of age (mean age 67 years). Most patients were male (74%), white (95%), and current or former smokers (65%). Approximately 93% of patients met criteria for definite IPF on high resolution computed tomography (HRCT).

Baseline mean %FVC and %DL CO were 72% and 46%, respectively. Approximately 15% subjects discontinued from each treatment group. Change from Baseline in Percent Predicted Forced Vital Capacity In Study 1, the primary efficacy analysis for the change in %FVC from baseline to Week 52 demonstrated a statistically significant treatment effect of pirfenidone tablets 2403 mg/day (n=278) compared with placebo (n=277) using a rank ANCOVA with the lowest rank imputation for missing data due to death.

In Study 2, there was a statistically significant difference at Week 72 for the change in %FVC from baseline. In Study 3, there was no statistically significant difference at Week 72 for the change in %FVC from baseline. Figure 1 presents the cumulative distribution for all cut-offs for the change from baseline in %FVC at Week 52 for Study 1.

For all categorical declines in lung function, the proportion of patients declining was lower on pirfenidone tablets than on placebo. Study 2 showed similar results. Figure 1.

Cumulative Distribution of Patients by Change in Percent Predicted FVC from Baseline to Week 52 (Study 1). The Dashed Lines Indicate ≥10% Decline or ≥0% Decline. Mean Change from Baseline in FVC (mL) In Study 1, a reduction in the mean decline in FVC (in mL) was observed in patients receiving pirfenidone tablets 2403 mg/day (-235 mL) compared to placebo (-428 mL) (mean treatment difference 193 mL) at Week 52 (see Figure 2).

In Study 2, a reduction in the decline in FVC volume was also observed in patients receiving pirfenidone tablets 2403 mg/day compared with placebo (mean treatment difference 157 mL) at Week 72. There was no statistically significant difference in decline in FVC volume seen in Study 3. Figure 2.

Mean Change from Baseline in Forced Vital Capacity (Study 1) Survival Survival was evaluated for pirfenidone tab… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term studies were conducted in mice and rats with admixture of pirfenidone to the diet to evaluate its carcinogenic potential. In a 24-month carcinogenicity study in B6C3F1 mice, pirfenidone caused statistically significant dose-related increases of the combination of hepatocellular adenoma and carcinoma and hepatoblastoma in male mice at doses of 800 mg/kg and above (AUC exposure approximately 0.4 times adult exposure at the MRDD). There were statistically significant dose-related increases of the combination of hepatocellular adenoma and carcinoma in female mice at doses of 2000 mg/kg and above (AUC exposure approximately 0.7 times adult exposure at the MRDD).

In a 24-month carcinogenicity study in Fischer rats, pirfenidone caused statistically significant dose-related increases of the combination of hepatocellular adenoma and carcinoma in male rats at doses of 750 mg/kg and above (AUC exposure approximately 1.9 times adult exposure at the MRDD). There were statistically significant increases of the combination of hepatocellular adenoma and carcinoma and the combination of uterine adenocarcinoma and adenoma at a dose of 1500 mg/kg/day (AUC exposure approximately 3 times adult exposure at the MRDD).

The relevance of these tumor findings in rodents to humans is unknown. Mutagenesis Pirfenidone was not mutagenic or clastogenic in the following tests: mutagenicity tests in bacteria, a chromosomal aberration test in Chinese hamster lung cells, and a micronucleus test in mice. Impairment of Fertility Pirfenidone had no effects on fertility and reproductive performance in rats at dosages up to 1000 mg/kg/day (approximately 3 times the MRDD in adults on a mg/m 2 basis).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~1 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term studies were conducted in mice and rats with admixture of pirfenidone to the diet to evaluate its carcinogenic potential. In a 24-month carcinogenicity study in B6C3F1 mice, pirfenidone caused statistically significant dose-related increases of the combination of hepatocellular adenoma and carcinoma and hepatoblastoma in male mice at doses of 800 mg/kg and above (AUC exposure approximately 0.4 times adult exposure at the MRDD). There were statistically significant dose-related increases of the combination of hepatocellular adenoma and carcinoma in female mice at doses of 2000 mg/kg and above (AUC exposure approximately 0.7 times adult exposure at the MRDD).

In a 24-month carcinogenicity study in Fischer rats, pirfenidone caused statistically significant dose-related increases of the combination of hepatocellular adenoma and carcinoma in male rats at doses of 750 mg/kg and above (AUC exposure approximately 1.9 times adult exposure at the MRDD). There were statistically significant increases of the combination of hepatocellular adenoma and carcinoma and the combination of uterine adenocarcinoma and adenoma at a dose of 1500 mg/kg/day (AUC exposure approximately 3 times adult exposure at the MRDD).

The relevance of these tumor findings in rodents to humans is unknown. Mutagenesis Pirfenidone was not mutagenic or clastogenic in the following tests: mutagenicity tests in bacteria, a chromosomal aberration test in Chinese hamster lung cells, and a micronucleus test in mice. Impairment of Fertility Pirfenidone had no effects on fertility and reproductive performance in rats at dosages up to 1000 mg/kg/day (approximately 3 times the MRDD in adults on a mg/m 2 basis).

📄 Package Label / Principal Display Panel 49 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 42571-335-90 Pirfenidone Tablets 267 mg Rx only 90 Tablets MICRO LABS NDC 42571-335-39 Pirfenidone Tablets 267 mg Rx only 270 Tablets (3 bottles of 90 tablets each) MICRO LABS NDC 42571-336-90 Pirfenidone Tablets 801 mg Rx only 90 Tablets MICRO LABS pirfenidone-267mglbl.jpg pirfenidone-267mgcrt.jpg pirfenidone-801mglbl.jpg

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Pirfenidone — the program that covers self-administered drugs. 10 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Pirfenidone. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$30.43M
Claims incl. refills
18.3K
Beneficiaries
7.6K
Spend / beneficiary
$3,980.59
Spend / claim
$1,662.26
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.
← 42571-0334-01 · Micro 42571-0336-90 · Micro →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.