Zileuton Tablet
Brand: ZYFLO
This drug is currently listed as to be discontinued by the FDA. Affected manufacturer: Chiesi USA, Inc..
Active FDA Drug Shortage
Contact your pharmacist if you are affected. They can check availability from other manufacturers or suggest alternatives.
Shortage Details
- Generic Name
- Zileuton Tablet
- Manufacturer
- Chiesi USA, Inc.
- Dosage Form
- Tablet
- Presentation
- Zyflo, Tablet, 600 mg (NDC 10122-901-12)
- Package NDC
- 10122-901-12
Status & Timeline
- Status
- To Be Discontinued
- First Reported
- Apr 1, 2025
- Last Updated
- Apr 1, 2025
- Therapeutic Category
- Pulmonary/Allergy
Frequently Asked Questions
Why is Zileuton in shortage?
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What This Zileuton Shortage Record Means
The FDA Drug Shortages database lists this record for Zileuton Tablet (brand: ZYFLO) from Chiesi USA, Inc. with a current status of To Be Discontinued. The affected dosage form is Tablet, presented as Zyflo, Tablet, 600 mg (NDC 10122-901-12). Shortages are tracked at the manufacturer and presentation level — other manufacturers or formulations of the same generic may remain available, which is why pharmacists often can source a working substitute even when one record is flagged.
This shortage was first reported on Apr 1, 2025 and was last updated Apr 1, 2025. FDA-supplied reason codes are not recorded for this entry; common drivers include manufacturing quality issues, raw-material constraints, demand surges, and voluntary business decisions to discontinue a presentation. No other current shortage records match this generic in the database, which can signal that either the disruption is contained to one manufacturer or other suppliers have not yet formally reported a shortfall.
A shortage listing is a supply-side signal, not a patient-level instruction. Access can vary dramatically by pharmacy, region, hospital system, and insurance formulary — local pharmacists have real-time visibility that a national database cannot provide. Therapeutic substitutes often exist in the same class, but switching decisions belong with your prescriber, who weighs efficacy, dosing conversion, interaction profile, and personal history. This page summarizes public FDA data for educational reference only and is not medical advice. If your medication is affected, contact your pharmacist and prescriber to plan an appropriate response.
Disclaimer: This information comes from the FDA Drug Shortages Database and is for educational purposes only. It is not medical advice. Do not stop or change any medication without consulting your healthcare provider or pharmacist. Shortage status can change rapidly — always verify current availability with your pharmacist.
Read our methodology — how this data is sourced, computed, and verified.