Umedica Laboratories Private Limited
Vapi, India · makes it, tests it and packages it
Problems found, fixed voluntarily Last FDA inspection Mar 29, 2024. 4 inspections on record.
NDC 70710-1166
Macitentan 10 mg tablet, film coated
On the label: Zydus Pharmaceuticals (USA) Inc..
Where it's made
Product details
- Generic drug
- Macitentan: see every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 10 mg
- Approval
- ANDA ANDA211224
- On the market since
- Nov 5, 2025
- Package NDCs
70710-1166-370710-1166-470710-1166-5- Official label
- DailyMed (National Library of Medicine), updated May 20, 2026
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