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Prescription medicine · generic available

Pirfenidone

Brand names: Esbriet

Drug class: Pyridone

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

NoBoxed warning
None listedFDA shortage list
2Recalls (FDA reports)
24Companies
2017First FDA approval on file

Quick answers

What is Pirfenidone used for?
The FDA-approved label (Esbriet, Genentech, Inc., December 5, 2025) says: “ESBRIET is indicated for the treatment of idiopathic pulmonary fibrosis (IPF). ESBRIET is a pyridone indicated for the treatment of idiopathic pulmonary fibrosis (IPF).” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Pirfenidone have a boxed warning?
No. None of the 33 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Pirfenidone?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Pirfenidone been recalled?
FDA enforcement reports list 2 recalls of products of this medicine; the newest started February 7, 2023 (Class II). A recall usually concerns specific lots, not every product.
Who makes Pirfenidone?
24 companies list prescription products of Pirfenidone in the FDA NDC Directory, including Amneal Pharmaceuticals NY LLC, Bryant Ranch Prepack and Laurus Labs Limited.

What Pirfenidone is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

ESBRIET is indicated for the treatment of idiopathic pulmonary fibrosis (IPF). ESBRIET is a pyridone indicated for the treatment of idiopathic pulmonary fibrosis (IPF).

— FDA label: Esbriet, Genentech, Inc., effective December 5, 2025. Read the full label on DailyMed →

The FDA has 33 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Conditions named on the label

These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.

Pulmonary fibrosis

Related medical specialties

Pulmonology

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

0 of 33 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsTablet, film coated · Tablet, coated · Capsule · Tablet
RouteOral
Prescription products61 in the FDA NDC Directory
Brand namesEsbriet

What pharmacies pay (NADAC)

The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.

This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.

NADAC per unit for Pirfenidone, by strength and form
Strength and formGeneric or brandPharmacies pay
pirfenidone 267 mg
tablet		 Generic $0.6527 per tablet
pirfenidone 267 mg
tablet, coated		 Generic $0.6527 per tablet
pirfenidone 267 mg
tablet, film coated		 Generic $0.6527 per tablet
pirfenidone 801 mg
tablet		 Generic $1.92 per tablet
pirfenidone 801 mg
tablet, coated		 Generic $1.92 per tablet
pirfenidone 801 mg
tablet, film coated		 Generic $1.92 per tablet

NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.

Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

FDA approval history

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA208780
ESBRIET		 LegacyJanuary 11, 2017 3, latest February 24, 2023
2023: Labeling · 2022: Labeling · 2019: Labeling

Generic approvals (18)

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

  1. February 7, 2023 · Class II · Terminated · D-0420-2023

    CGMP Deviations: recalling drug products following an FDA inspection.

    Pirfenidone Tablets 801 mg, Rx Only, 90-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. NDC 16729-468-15, UPC 3 — Accord Healthcare, Inc.

  2. February 7, 2023 · Class II · Terminated · D-0419-2023

    CGMP Deviations: recalling drug products following an FDA inspection.

    Pirfenidone Tablets 267 mg 90-count bottle x3/Carton, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. Bottle NDC 167 — Accord Healthcare, Inc.

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

Official identifiers

RxCUI (RxNorm)1592279, 1592285, 1868014, 1868016, 1868018, 1868020, 2606490, 2606491
SPL set ID of the quoted label2e8c3537-36d7-4de5-9b5c-7a624b9a9e6e
FDA labels (SPL)33
FDA applicationsNDA208780, 18 ANDA
Active ingredients (FDA)PIRFENIDONE

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Esbriet, Genentech, Inc., effective December 5, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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