"55292-321-60" National Drug Code (NDC)

Isturisa 60 TABLET, COATED in 1 BLISTER PACK (55292-321-60)
(Recordati Rare Diseases, Inc.)

NDC Code55292-321-60
Package Description60 TABLET, COATED in 1 BLISTER PACK (55292-321-60)
Product NDC55292-321
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameIsturisa
Non-Proprietary NameOsilodrostat
Dosage FormTABLET, COATED
UsageORAL
Start Marketing Date20200331
Marketing Category NameNDA
Application NumberNDA212801
ManufacturerRecordati Rare Diseases, Inc.
Substance NameOSILODROSTAT PHOSPHATE
Strength5
Strength Unitmg/1
Pharmacy ClassesCortisol Synthesis Inhibitor [EPC], Cytochrome P450 11B1 Inhibitors [MoA], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA]

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