Product Information
ZILEUTON ER 600 MG TABLET is a generic product labeled by Strides Pharma Inc., priced at $2.0493 per EA under NDC 64380018901. Its NADAC has been published 178 times since Dec 14, 2022.
FDA first approved this application on Dec 16, 2019. Its Orange Book therapeutic-equivalence code is AB — FDA rates it therapeutically equivalent to (substitutable for) its reference product.
Strength
600 mg/1
Manufacturer
Strides Pharma Inc.NDC
64380018901
Classification
Generic
Dosage Form
TABLET, MULTILAYER, EXTENDED RELEASE
Route
ORAL
Effective Date
9/23/2026
Active Ingredients
ZILEUTONApproval Type
Generic (ANDA)
FDA Application
ANDA212670FDA Approved
12/16/2019
TE Code
AB
On Market Since
10/15/2022
Pharmacological Classes
Price Statistics
The NADAC for ZILEUTON ER 600 MG TABLET has been published 178 times since Dec 14, 2022, and over the history we have for it it has declined 79.5%. The table below summarizes its recorded NADAC range and movement.
| Current price | $2.0493 per EA |
|---|---|
| All-time high | $10.0166 (Nov 15, 2023) |
| All-time low | $1.9211 (Jun 17, 2026) |
| 52-week high | $3.0625 |
| 52-week low | $1.9211 |
| Median price | $4.5430 |
| Average price | $5.4114 |
| Largest weekly change | -36.1% (Apr 17, 2024) |
| Weeks tracked | 178 |
| Tracking since | Dec 14, 2022 |
Generic Alternatives
No other NADAC-published product shares this drug's active ingredient and strength in a comparable dosage form. Compare the broader picture on the zileuton market page.
Lowest-Cost Alternatives
No alternatives available
Related Drugs
Same classification
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Manufacturer
Strides Pharma Inc. manufacturer profile
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Drug market
zileuton market comparison
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Trend hub
Latest market trends
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Guide
Understanding NADAC pricing
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Frequently asked questions
What is the NADAC price of ZILEUTON ER 600 MG TABLET?
The current National Average Drug Acquisition Cost (NADAC) for ZILEUTON ER 600 MG TABLET, manufactured by Strides Pharma Inc., is $2.0493 per EA (NDC 64380018901), effective Sep 30, 2026.
How has the price of ZILEUTON ER 600 MG TABLET changed over time?
Over the history we have for it, the NADAC for ZILEUTON ER 600 MG TABLET has declined 79.5%. It has been tracked across 178 weekly CMS publications since Dec 14, 2022.
What are the highest and lowest recorded NADAC prices for ZILEUTON ER 600 MG TABLET?
Since Dec 14, 2022, the NADAC for ZILEUTON ER 600 MG TABLET has ranged from a low of $1.9211 (Jun 17, 2026) to a high of $10.0166 (Nov 15, 2023), with a median of $4.5430 per EA.
Are there cheaper alternatives to ZILEUTON ER 600 MG TABLET?
No other NADAC-published product currently shares the active ingredient and strength of ZILEUTON ER 600 MG TABLET in a comparable dosage form, so no direct lower-cost alternative is listed.
Who manufactures ZILEUTON ER 600 MG TABLET?
ZILEUTON ER 600 MG TABLET (NDC 64380018901) is labeled by Strides Pharma Inc., and CMS classifies it as a generic product.