Zileuton

  • Part D specialty tier in 55% of formularies (2026Q3)

Therapy management checklist

Screening, baseline and ongoing monitoring with the label's stated frequency, hold and discontinue criteria, and counseling points, each quoted from the FDA label.

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Storage and cold chain

Zileuton: storage and handling

Freezing
Not addressed
Room temperature
at or below 25°C (86°F)
Label statement
Store between 20 to 25°C (68 to 77°F); excursions permitted to 15-30°C (59 to 86°F) [see USP Controlled Room Temperature].
Room temperature
at or below 25°C (77°F)
Label statement
Store at controlled room temperature, 20 to 25°C (68° to 77°F) see USP.
Back into the refrigerator
Not addressed
Light
Protect from light
Label statement
Protect from light.
Shaking
Not addressed

Temperature excursion helper

Answers only from this label's storage statements. It does not judge whether a product is still usable beyond what the label states.

Within the label's stated room-temperature allowance (at up to 25°C (86°F)). Follow the label's instructions for what to do next.

Entered: 1 day at up to 77°F (25°C).

Store between 20 to 25°C (68 to 77°F); excursions permitted to 15-30°C (59 to 86°F) [see USP Controlled Room Temperature].

If anything else happened to the product, or you are unsure, Contact the manufacturer at 1-844-874-7464 (the number printed on the label) about this product.

Where the label prints this number
at 1-844-874-7464 What are the ingredients in Zileuton Extended-Release Tablets? Active ingredient: zileuton Inactive ingredients: colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, partially pregelatinized maize starch, polyethylene glycol 400, sodium lauryl sulfate, sodium starch glycolate, titanium dioxide, yellow iron oxide.
All storage statements on the label (3)
  • Store between 20 to 25°C (68 to 77°F); excursions permitted to 15-30°C (59 to 86°F) [see USP Controlled Room Temperature].
  • Protect from light.
  • Store at controlled room temperature, 20 to 25°C (68° to 77°F) see USP.

FDA label version 7, effective May 15, 2024. DailyMed

Dosing and titration calendar

Built only from the schedules the label states (loading, titration, day schedules, cycles and weight bands). Steps the label states in words the calendar cannot place are shown, not guessed.

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Medicare Part D coverage

3%of plans list it
37%of those: prior authorization
0%step therapy
26%quantity limit
30%specialty tier

5,496 Part D plans, CMS formulary files 2026Q3. Look up tier, PA, step therapy and quantity limits by plan

Patient assistance

No manufacturer program page is listed for this drug yet.

Independent foundations and the full directory (checked 2026-11-06). Eligibility and amounts are set by each program; open its page for them.

For licensed clinicians. Use with clinical judgment. Statements are quoted from the FDA label; confirm against the label for the product you are using.