"46708-383-60" National Drug Code (NDC)

Bosentan 60 TABLET, FILM COATED in 1 BOTTLE (46708-383-60)
(Alembic Pharmaceuticals Limited)

NDC Code46708-383-60
Package Description60 TABLET, FILM COATED in 1 BOTTLE (46708-383-60)
Product NDC46708-383
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameBosentan
Non-Proprietary NameBosentan
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20200124
Marketing Category NameANDA
Application NumberANDA211461
ManufacturerAlembic Pharmaceuticals Limited
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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