55292-322 NDC - ISTURISA (OSILODROSTAT)

Drug Information

Product NDC: 55292-322

Proprietary Name: Isturisa

Non Proprietary Name: Osilodrostat

Active Ingredient(s):
  • 10 mg/1 OSILODROSTAT PHOSPHATE


Administration Route(s): ORAL

Dosage Form(s): TABLET, COATED

Pharmacy Class(es):
  • Cortisol 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]

Labeler Information

Labeler Name: Recordati Rare Diseases, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA212801
Marketing Category: NDA
Start Marketing Date:3/31/2020

Package Information

No. Package Code Package Description Billing Unit
155292-322-2020 TABLET, COATED in 1 BLISTER PACK (55292-322-20)EA
255292-322-6060 TABLET, COATED in 1 BLISTER PACK (55292-322-60)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC55292-322The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMEIsturisaThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEOsilodrostatThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMETABLET, COATEDThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE3/31/2020This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMENDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERNDA212801This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMERecordati Rare Diseases, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEOSILODROSTAT PHOSPHATEAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH10 
ACTIVE INGRED UNITmg/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] 

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This page was last updated on: 2/1/2023