NDC 55292-322

Isturisa

Osilodrostat

Isturisa is a Oral Tablet, Coated in the Human Prescription Drug category. It is labeled and distributed by Recordati Rare Diseases, Inc.. The primary component is Osilodrostat Phosphate.

Product ID55292-322_06e491a0-5048-424a-9fa3-5109679d7908
NDC55292-322
Product TypeHuman Prescription Drug
Proprietary NameIsturisa
Generic NameOsilodrostat
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2020-03-31
Marketing CategoryNDA / NDA
Application NumberNDA212801
Labeler NameRecordati Rare Diseases, Inc.
Substance NameOSILODROSTAT PHOSPHATE
Active Ingredient Strength10 mg/1
Pharm 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]
NDC Exclude FlagN
Listing Certified Through2024-12-31

Packaging

NDC 55292-322-20

20 TABLET, COATED in 1 BLISTER PACK (55292-322-20)
Marketing Start Date2020-03-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55292-322-20 [55292032220]

Isturisa TABLET, COATED
Marketing CategoryNDA
Application NumberNDA212801
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-03-31

NDC 55292-322-60 [55292032260]

Isturisa TABLET, COATED
Marketing CategoryNDA
Application NumberNDA212801
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-03-31

Drug Details

Active Ingredients

IngredientStrength
OSILODROSTAT PHOSPHATE10 mg/1

OpenFDA Data

SPL SET ID:f3a5ec24-63c3-4d83-b1c0-6c550fbe7ae2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2286283
  • 2286290
  • 2286281
  • 2286288
  • 2286285
  • 2286275
  • NDC Crossover Matching brand name "Isturisa" or generic name "Osilodrostat"

    NDCBrand NameGeneric Name
    55292-320IsturisaOsilodrostat
    55292-321IsturisaOsilodrostat
    55292-322IsturisaOsilodrostat

    Trademark Results [Isturisa]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ISTURISA
    ISTURISA
    79187535 5061675 Live/Registered
    NOVARTIS AG
    2016-03-30

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