# Macitentan

NDC: 0378-0606
Generic name: Macitentan
Labeler / Manufacturer: Mylan Pharmaceuticals Inc.
Product type: HUMAN PRESCRIPTION DRUG
Marketing category: Abbreviated NDA (generic)
Dosage form: TABLET, FILM COATED
Routes: ORAL
Marketing started: 20260608

FDA application: ANDA211161

## 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:"0378-0606"
- FDA NDC Directory: https://www.accessdata.fda.gov/scripts/cder/ndc/dsp_searchresult.cfm?p_ndc=0378-0606
- DailyMed: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d88a13e7-cf08-4632-86be-dcd979516296