OPSYNVI

NDC 66215-812 · Actelion Pharmaceuticals US, Inc.

Generic namemacitentan and tadalafil

Dosage formTABLET, FILM COATED

RouteORAL

Active ingredient(s)MACITENTAN, TADALAFIL

Strength10; 20 mg/1; mg/1

Pharmacologic classEndothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA], Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]

Marketing categoryNDA

Packages

66215-812-07 — 1 BOTTLE in 1 CARTON (66215-812-07) / 7 TABLET, FILM COATED in 1 BOTTLE

66215-812-08 — 1 BLISTER PACK in 1 CARTON (66215-812-08) / 7 TABLET, FILM COATED in 1 BLISTER PACK (66215-812-01)

66215-812-30 — 1 BOTTLE in 1 CARTON (66215-812-30) / 30 TABLET, FILM COATED in 1 BOTTLE

Related Codes

Same active ingredient

FDA lists these products with the same active ingredient.

62332-373 — Macitentan, 63629-8157 — Tadalafil, 63629-8288 — Tadalafil, 63629-8409 — Tadalafil, 65862-850 — Tadalafil, 65862-851 — Tadalafil, 65862-852 — Tadalafil, 65862-853 — Tadalafil, 65862-880 — Tadalafil, 66215-501 — macitentan, 66215-814 — macitentan and tadalafil, 66302-467 — Tadalafil, 67184-0523 — Tadalafil, 67184-0524 — Tadalafil, 67184-0525 — Tadalafil, 67184-0526 — Tadalafil, 67296-2237 — tadalafil, 68071-2421 — Tadalafil, 68071-2553 — Tadalafil, 68071-2554 — Tadalafil, +244 more

From the FDA National Drug Code Directory, retrieved 2026-08-24. Product listings are submitted by labelers; FDA does not verify them.