Macitentan
Active substance: macitentan
TABLET, FILM COATED · MACITENTAN 10 mg/1
United StatesActive
Marketing holder: ANI Pharmaceuticals, Inc.
Verified 2026-10-09 · openFDA NDC
Analogues in other countries- Source: openFDA NDC
- Countries with the substance registered: 2
Composition
- MACITENTAN · 10 mg/1
Analogues by country
Products with the same active substance registered in other countries.
| Country | Products |
|---|---|
| EU 4 |
|
Import and control
Control by country
- United Statesprescription only
Source: openFDA NDC · record 01a1208c-277c-7535-94f6-8882faa2ce1d,01a1208c-9b74-7414-8a97-d3af9c35e983,01a1208d-1677-7075-8ad3-9117770f9c8c,01a1208e-8f85-7b03-9be0-e01c64329f75,01a1208e-c5c7-7368-b12d-b719891ee518;count=16 · valid from 2026-10-09 · verified 2026-10-09
Registration
- Registration number
- 70954-025
- Registration status
- Active
- Dispensing
- Prescription only
- Route
- ORAL
Sources
- product · openFDA NDC · 70954-025 · Verified 2026-10-09 · open in source
- registration_status · openFDA NDC · 70954-025 · Verified 2026-10-09 · open in source
- ingredients.0 · openFDA NDC · 70954-025 · Verified 2026-10-09 · open in source