MedPath
FDA Approval

Isturisa

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Recordati Rare Diseases, Inc.
DUNS: 181699406
Effective Date
November 3, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Osilodrostat(1 mg in 1 1)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Novartis Pharma Stein AG

488152505

Manufacturing Establishments2

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Novartis Pharma Stein AG

Recordati Rare Diseases, Inc.

488152505

PENN PHARMACEUTICAL SERVICES LIMITED

Recordati Rare Diseases, Inc.

226277259

Products5

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Isturisa

Product Details

NDC Product Code
55292-330
Application Number
NDA212801
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
April 25, 2025
OsilodrostatActive
Code: Y6581YAW9VClass: ACTIMQuantity: 1 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT

Isturisa

Product Details

NDC Product Code
55292-331
Application Number
NDA212801
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
April 25, 2025
OsilodrostatActive
Code: Y6581YAW9VClass: ACTIMQuantity: 5 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT

Isturisa

Product Details

NDC Product Code
55292-320
Application Number
NDA212801
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
November 3, 2023
OsilodrostatActive
Code: Y6581YAW9VClass: ACTIMQuantity: 1 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95Class: IACT

Isturisa

Product Details

NDC Product Code
55292-321
Application Number
NDA212801
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
November 3, 2023
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
OsilodrostatActive
Code: Y6581YAW9VClass: ACTIMQuantity: 5 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT

Isturisa

Product Details

NDC Product Code
55292-322
Application Number
NDA212801
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
November 3, 2023
OsilodrostatActive
Code: Y6581YAW9VClass: ACTIMQuantity: 10 mg in 1 1
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95Class: IACT
© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy