NDC 42385-907

Macitentan 10 mg tablet, film coated

On the label: Laurus Labs Limited.

Where it's made

Laurus Labs Limited

Anakapalli, India · makes it and tests it

Problems found, fixed voluntarily Last FDA inspection Feb 10, 2023. 2 inspections on record.

Product details

Generic drug
Macitentan: see every company that makes it
Form
tablet, film coated, oral
Strength
10 mg
Approval
ANDA ANDA211120
On the market since
May 15, 2026
Package NDCs
42385-907-15 42385-907-30
Official label
DailyMed (National Library of Medicine), updated Nov 10, 2025

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