Isturisa
These highlights do not include all the information needed to use ISTURISA safely and effectively. See full prescribing information for ISTURISA. ISTURISA (osilodrostat) tablets, for oral use Initial U.S. Approval: 2020
Approved
Approval ID
f3a5ec24-63c3-4d83-b1c0-6c550fbe7ae2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 3, 2023
Manufacturers
FDA
Recordati Rare Diseases, Inc.
DUNS: 181699406
Products 5
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Osilodrostat
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55292-330
Application NumberNDA212801
Product Classification
M
Marketing Category
C73594
G
Generic Name
Osilodrostat
Product Specifications
Route of AdministrationORAL
Effective DateApril 25, 2025
FDA Product Classification
INGREDIENTS (12)
OSILODROSTAT PHOSPHATEActive
Quantity: 1 mg in 1 1
Code: Y6581YAW9V
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
Osilodrostat
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55292-331
Application NumberNDA212801
Product Classification
M
Marketing Category
C73594
G
Generic Name
Osilodrostat
Product Specifications
Route of AdministrationORAL
Effective DateApril 25, 2025
FDA Product Classification
INGREDIENTS (11)
OSILODROSTAT PHOSPHATEActive
Quantity: 5 mg in 1 1
Code: Y6581YAW9V
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
Osilodrostat
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55292-320
Application NumberNDA212801
Product Classification
M
Marketing Category
C73594
G
Generic Name
Osilodrostat
Product Specifications
Route of AdministrationORAL
Effective DateNovember 3, 2023
FDA Product Classification
INGREDIENTS (12)
OSILODROSTAT PHOSPHATEActive
Quantity: 1 mg in 1 1
Code: Y6581YAW9V
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
Osilodrostat
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55292-321
Application NumberNDA212801
Product Classification
M
Marketing Category
C73594
G
Generic Name
Osilodrostat
Product Specifications
Route of AdministrationORAL
Effective DateNovember 3, 2023
FDA Product Classification
INGREDIENTS (11)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
OSILODROSTAT PHOSPHATEActive
Quantity: 5 mg in 1 1
Code: Y6581YAW9V
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
Osilodrostat
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55292-322
Application NumberNDA212801
Product Classification
M
Marketing Category
C73594
G
Generic Name
Osilodrostat
Product Specifications
Route of AdministrationORAL
Effective DateNovember 3, 2023
FDA Product Classification
INGREDIENTS (12)
OSILODROSTAT PHOSPHATEActive
Quantity: 10 mg in 1 1
Code: Y6581YAW9V
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT