opsumit

Generic: macitentan

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

Drug Facts

Product Profile

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

macitentan 10 mg/1

Manufacturer
Actelion Pharmaceuticals US, Inc.

Identifiers & Regulatory

Product NDC 66215-501
Product ID 66215-501_3282790e-e454-3214-e063-6294a90a526b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA204410
Listing Expiration 2026-12-31
Marketing Start 2013-11-04

Pharmacologic Class

Established (EPC)
endothelin receptor antagonist [epc]
Mechanism of Action
endothelin receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 66215501
Hyphenated Format 66215-501

Supplemental Identifiers

RxCUI
1442137 1442143
UNII
Z9K9Y9WMVL
NUI
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 opsumit (source: ndc)
Generic Name macitentan (source: ndc)
Application Number NDA204410 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (66215-501-15) / 15 TABLET, FILM COATED in 1 BLISTER PACK
  • 1 BOTTLE in 1 CARTON (66215-501-30) / 30 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (2)

66215-501-15 1 BLISTER PACK in 1 CARTON (66215-501-15) / 15 TABLET, FILM COATED in 1 BLISTER PACK 66215-501-30 1 BOTTLE in 1 CARTON (66215-501-30) / 30 TABLET, FILM COATED in 1 BOTTLE

Ingredients (1)

macitentan (10 mg/1)

Linked Drug Pages (1)

OPSUMIT ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3282790e-e454-3214-e063-6294a90a526b", "openfda": {"nui": ["N0000175581", "N0000175364"], "unii": ["Z9K9Y9WMVL"], "rxcui": ["1442137", "1442143"], "spl_set_id": ["1e484a50-55db-4b85-8c57-6cd1b0353abd"], "pharm_class_epc": ["Endothelin Receptor Antagonist [EPC]"], "pharm_class_moa": ["Endothelin Receptor Antagonists [MoA]"], "manufacturer_name": ["Actelion Pharmaceuticals US, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (66215-501-15)  / 15 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "66215-501-15", "marketing_start_date": "20131104"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (66215-501-30)  / 30 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "66215-501-30", "marketing_start_date": "20131104"}], "brand_name": "OPSUMIT", "product_id": "66215-501_3282790e-e454-3214-e063-6294a90a526b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Endothelin Receptor Antagonist [EPC]", "Endothelin Receptor Antagonists [MoA]"], "product_ndc": "66215-501", "generic_name": "macitentan", "labeler_name": "Actelion Pharmaceuticals US, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "OPSUMIT", "active_ingredients": [{"name": "MACITENTAN", "strength": "10 mg/1"}], "application_number": "NDA204410", "marketing_category": "NDA", "marketing_start_date": "20131104", "listing_expiration_date": "20261231"}