NDC 68382-446

Bosentan 62.5 mg tablet, coated

On the label: Zydus Pharmaceuticals (USA) Inc..

India: 1

Where it's made

FactoryWhereRoleLast FDA inspection
Zydus Lifesciences LimitedAhmedabad, IndiaMakes it and tests it Problems found, fixed voluntarilyMar 24, 2023 · 5 inspections

Product details

Generic drug
Bosentan: every company that makes it
Form
tablet, coated, oral
Strength
62.5 mg
Approval
ANDA ANDA207760
On the market since
May 1, 2019
Package NDCs
68382-446-01 68382-446-05 68382-446-14 68382-446-28 68382-446-30 68382-446-77
Official label
DailyMed (National Library of Medicine), updated Jun 2, 2026

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