opsynvi

Generic: macitentan and tadalafil

Labeler: actelion pharmaceuticals us, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name opsynvi
Generic Name macitentan and tadalafil
Labeler actelion pharmaceuticals us, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

macitentan 10 mg/1, tadalafil 20 mg/1

Manufacturer
Actelion Pharmaceuticals US, Inc.

Identifiers & Regulatory

Product NDC 66215-812
Product ID 66215-812_32840e17-39b6-50b2-e063-6394a90a7a37
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA218490
Listing Expiration 2026-12-31
Marketing Start 2024-03-22

Pharmacologic Class

Established (EPC)
phosphodiesterase 5 inhibitor [epc] endothelin receptor antagonist [epc]
Mechanism of Action
phosphodiesterase 5 inhibitors [moa] endothelin receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 66215812
Hyphenated Format 66215-812

Supplemental Identifiers

RxCUI
2677765 2677771 2677773 2677775
UNII
742SXX0ICT Z9K9Y9WMVL
NUI
N0000175599 N0000020026 N0000175581 N0000175364

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name opsynvi (source: ndc)
Generic Name macitentan and tadalafil (source: ndc)
Application Number NDA218490 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
  • 20 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (66215-812-07) / 7 TABLET, FILM COATED in 1 BOTTLE
  • 1 BLISTER PACK in 1 CARTON (66215-812-08) / 7 TABLET, FILM COATED in 1 BLISTER PACK (66215-812-01)
  • 1 BOTTLE in 1 CARTON (66215-812-30) / 30 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (3)

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

Ingredients (2)

macitentan (10 mg/1) tadalafil (20 mg/1)

Linked Drug Pages (1)

OPSYNVI ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "32840e17-39b6-50b2-e063-6394a90a7a37", "openfda": {"nui": ["N0000175599", "N0000020026", "N0000175581", "N0000175364"], "unii": ["742SXX0ICT", "Z9K9Y9WMVL"], "rxcui": ["2677765", "2677771", "2677773", "2677775"], "spl_set_id": ["6945b183-18d3-40de-afd1-c88e33cc1a63"], "pharm_class_epc": ["Phosphodiesterase 5 Inhibitor [EPC]", "Endothelin Receptor Antagonist [EPC]"], "pharm_class_moa": ["Phosphodiesterase 5 Inhibitors [MoA]", "Endothelin Receptor Antagonists [MoA]"], "manufacturer_name": ["Actelion Pharmaceuticals US, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (66215-812-07)  / 7 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "66215-812-07", "marketing_start_date": "20240322"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (66215-812-08)  / 7 TABLET, FILM COATED in 1 BLISTER PACK (66215-812-01)", "package_ndc": "66215-812-08", "marketing_start_date": "20240322"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (66215-812-30)  / 30 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "66215-812-30", "marketing_start_date": "20240322"}], "brand_name": "OPSYNVI", "product_id": "66215-812_32840e17-39b6-50b2-e063-6394a90a7a37", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Endothelin Receptor Antagonist [EPC]", "Endothelin Receptor Antagonists [MoA]", "Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "66215-812", "generic_name": "macitentan and tadalafil", "labeler_name": "Actelion Pharmaceuticals US, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "OPSYNVI", "active_ingredients": [{"name": "MACITENTAN", "strength": "10 mg/1"}, {"name": "TADALAFIL", "strength": "20 mg/1"}], "application_number": "NDA218490", "marketing_category": "NDA", "marketing_start_date": "20240322", "listing_expiration_date": "20261231"}