"68382-446-01" National Drug Code (NDC)

Bosentan 100 TABLET, COATED in 1 BOTTLE (68382-446-01)
(Zydus Pharmaceuticals USA Inc.)

NDC Code68382-446-01
Package Description100 TABLET, COATED in 1 BOTTLE (68382-446-01)
Product NDC68382-446
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
Strength62.5
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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