United States · FDA National Drug Code directory

Macitentan

A source-listed medicine record.

Factual source checks only. This page is not a clinically reviewed monograph. Historical or discontinued records may be included; listing does not confirm approval, current availability or pharmacy stock.

Medicine identity

Source reference
69238-1327_d30251d5-e7c1-4c77-9171-adaac14db92e
Product NDC
69238-1327
Form
TABLET, FILM COATED
Composition / generic term
Macitentan
Labeler
Amneal Pharmaceuticals NY LLC
Marketing category
ANDA
Marketing start / end (source format)
20260608
Source listing expiry
20271231

Source-listed ingredients

  • MACITENTAN — 10 mg/1

These values do not establish equivalence or a dose recommendation.

Packages

  • 1 BOTTLE in 1 CARTON (69238-1327-3) / 30 TABLET, FILM COATED in 1 BOTTLE · 69238-1327-3

Source and coverage

Open FDA National Drug Code directory

Snapshot retrieved: 2026-09-17. This is the acquisition date, not a medical review date.

Clinical information, images and comparisons appear only when separately reviewed for this record. Coverage may be incomplete. Ask a pharmacist or clinician about your treatment.

Browse United States records →