# OPSUMIT

NDC: 66215-501
Generic name: macitentan
Labeler / Manufacturer: Actelion Pharmaceuticals US, Inc.
Product type: HUMAN PRESCRIPTION DRUG
Marketing category: New Drug Application (innovator)
Dosage form: TABLET, FILM COATED
Routes: ORAL
Marketing started: 20131104

FDA application: NDA204410

## Active ingredients

- MACITENTAN: 10 mg/1

## Pharmacological class

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## External sources

- openFDA: https://api.fda.gov/drug/ndc.json?search=product_ndc:"66215-501"
- FDA NDC Directory: https://www.accessdata.fda.gov/scripts/cder/ndc/dsp_searchresult.cfm?p_ndc=66215-501
- DailyMed: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=1e484a50-55db-4b85-8c57-6cd1b0353abd