bosentan

openFDA label record#

Cross-check layer: This is openFDA JSON-derived label data. Use the corresponding DailyMed SPL as the canonical label.

Brand name
bosentan
Generic name
BOSENTAN
Manufacturer
Zydus Lifesciences Limited
Product type
HUMAN PRESCRIPTION DRUG
SPL set ID
b88cc559-93ae-42db-9c38-fb5e9c4802e6
SPL ID
008fc213-caa0-4d52-9ee2-e3628c19b90b
Version
1
Effective date
2026-02-14
Source export date
2026-08-01
Applications, Product NDCs, Package NDCs table
ApplicationsProduct NDCsPackage NDCsRxCUIsUNIIsRoutes
ANDA21398170771-190870771-1908-7, 70771-1908-81989081Q326023R30ORAL