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Zileuton

Active substance: zileuton

TABLET, MULTILAYER, EXTENDED RELEASE · ZILEUTON 600 mg/1

United StatesActive

Marketing holder: Strides Pharma Science Limited

Verified 2026-10-09 · openFDA NDC

Composition
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208c-cb3b-7bfe-baf0-481536c3c17e,01a12093-3d76-701a-998b-31bb29f51d4f,01a12093-4f3c-7289-8e03-d69d7fbe1a9a,01a12098-c177-7b44-81c6-a778a7d4c1e4,01a1209b-8b81-7b00-8ea1-ac583f843b07;count=6 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
64380-189
Registration status
Active
Dispensing
Prescription only
Route
ORAL
Sources
  • product · openFDA NDC · 64380-189 · Verified 2026-10-09 · open in source
  • registration_status · openFDA NDC · 64380-189 · Verified 2026-10-09 · open in source
  • ingredients.0 · openFDA NDC · 64380-189 · Verified 2026-10-09 · open in source