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bosentan

Active substance: bosentan

TABLET, FILM COATED · BOSENTAN 62.5 mg/1

United StatesActive

Marketing holder: Actavis Pharma, Inc.

Verified 2026-10-09 · openFDA NDC

Analogues in other countries
Composition
Analogues by country

Products with the same active substance registered in other countries.

CountryProducts
EU 2
  • Stayveer
    bosentan (as monohydrate)
    EMEA/H/C/002644
    Janssen-Cilag International NV
  • Tracleer
    bosentan (as monohydrate)
    EMEA/H/C/000401
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208c-30db-706a-8889-8d46a479cd45,01a1208d-8dc1-7ac9-98e9-7d17799344db,01a1208d-a86a-72c2-a74f-835866ce2447,01a1208d-c3ac-78dc-8c20-24d3518a1a2c,01a1208e-b0bc-787d-ad4b-ece7376cea85;count=14 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
0591-2511
Registration status
Active
Dispensing
Prescription only
Route
ORAL
Sources
  • product · openFDA NDC · 0591-2511 · Verified 2026-10-09 · open in source
  • registration_status · openFDA NDC · 0591-2511 · Verified 2026-10-09 · open in source
  • ingredients.0 · openFDA NDC · 0591-2511 · Verified 2026-10-09 · open in source