Product Information
PIRFENIDONE 801 MG TABLET is a generic product labeled by Apotex Corp., priced at $1.9618 per EA under NDC 60505468209. Its NADAC has been published 118 times since Jul 3, 2024.
FDA first approved this application on May 31, 2023. Its Orange Book therapeutic-equivalence code is AB — FDA rates it therapeutically equivalent to (substitutable for) its reference product.
Strength
801 mg/1
Manufacturer
Apotex Corp.NDC
60505468209
Classification
Generic
Dosage Form
TABLET
Route
ORAL
Effective Date
9/23/2026
Active Ingredients
PIRFENIDONEApproval Type
Generic (ANDA)
FDA Application
ANDA212709FDA Approved
5/31/2023
TE Code
AB
On Market Since
4/9/2024
Pharmacological Classes
Price Statistics
The NADAC for PIRFENIDONE 801 MG TABLET has been published 118 times since Jul 3, 2024, and over the history we have for it it has declined 74.6%. The table below summarizes its recorded NADAC range and movement.
| Current price | $1.9618 per EA |
|---|---|
| All-time high | $7.7174 (Sep 11, 2024) |
| All-time low | $1.9618 (Sep 23, 2026) |
| 52-week high | $4.3015 |
| 52-week low | $1.9618 |
| Median price | $4.1179 |
| Average price | $4.6027 |
| Largest weekly change | -27.3% (Nov 20, 2024) |
| Weeks tracked | 118 |
| Tracking since | Jul 3, 2024 |
Generic Alternatives
The matcher finds 10 manufacturers offering a NADAC-published product with this drug's active ingredient and strength in a comparable dosage form (cheapest from each manufacturer, up to 10 shown below). None of the shown alternatives sit below the current price. These are candidates to verify clinically, not guaranteed substitutes — see our generic drug prices guide.
Related Drugs
Same classification
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Manufacturer
Apotex Corp. manufacturer profile
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Drug market
Pirfenidone market comparison
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Therapeutic class
Pyridone class view
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Trend hub
Latest market trends
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Guide
Understanding NADAC pricing
Use the explainer when you need context on how CMS publishes NADAC and how to interpret the number on this page.
Frequently asked questions
What is the NADAC price of PIRFENIDONE 801 MG TABLET?
The current National Average Drug Acquisition Cost (NADAC) for PIRFENIDONE 801 MG TABLET, manufactured by Apotex Corp., is $1.9618 per EA (NDC 60505468209), effective Sep 30, 2026.
How has the price of PIRFENIDONE 801 MG TABLET changed over time?
Over the history we have for it, the NADAC for PIRFENIDONE 801 MG TABLET has declined 74.6%. It has been tracked across 118 weekly CMS publications since Jul 3, 2024.
What are the highest and lowest recorded NADAC prices for PIRFENIDONE 801 MG TABLET?
Since Jul 3, 2024, the NADAC for PIRFENIDONE 801 MG TABLET has ranged from a low of $1.9618 (Sep 23, 2026) to a high of $7.7174 (Sep 11, 2024), with a median of $4.1179 per EA.
Are there cheaper alternatives to PIRFENIDONE 801 MG TABLET?
10 manufacturers publish a NADAC-priced product with the same active ingredient and strength as PIRFENIDONE 801 MG TABLET in a comparable dosage form, but none are currently priced below it.
Who manufactures PIRFENIDONE 801 MG TABLET?
PIRFENIDONE 801 MG TABLET (NDC 60505468209) is labeled by Apotex Corp., and CMS classifies it as a generic product.