# OPSYNVI

NDC: 66215-812
Generic name: macitentan and tadalafil
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: 20240322

FDA application: NDA218490

## Active ingredients

- MACITENTAN: 10 mg/1
- TADALAFIL: 20 mg/1

## Pharmacological class

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## External sources

- openFDA: https://api.fda.gov/drug/ndc.json?search=product_ndc:"66215-812"
- FDA NDC Directory: https://www.accessdata.fda.gov/scripts/cder/ndc/dsp_searchresult.cfm?p_ndc=66215-812
- DailyMed: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=6945b183-18d3-40de-afd1-c88e33cc1a63