"68382-447-14" National Drug Code (NDC)

Bosentan 60 TABLET, COATED in 1 BOTTLE (68382-447-14)
(Zydus Pharmaceuticals USA Inc.)

NDC Code68382-447-14
Package Description60 TABLET, COATED in 1 BOTTLE (68382-447-14)
Product NDC68382-447
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameBosentan
Non-Proprietary NameBosentan
Dosage FormTABLET, COATED
UsageORAL
Start Marketing Date20190501
Marketing Category NameANDA
Application NumberANDA207760
ManufacturerZydus Pharmaceuticals USA Inc.
Substance NameBOSENTAN
Strength125
Strength Unitmg/1
Pharmacy ClassesCytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]

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