isturisa

Generic: osilodrostat

Labeler: recordati rare diseases, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name isturisa
Generic Name osilodrostat
Labeler recordati rare diseases, inc.
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

osilodrostat phosphate 1 mg/1

Manufacturer
Recordati Rare Diseases, Inc.

Identifiers & Regulatory

Product NDC 55292-330
Product ID 55292-330_5c1e5bfa-9d7b-4a4a-b030-caf7bb57c6df
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA212801
Listing Expiration 2026-12-31
Marketing Start 2020-03-31

Pharmacologic Class

Classes
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]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55292330
Hyphenated Format 55292-330

Supplemental Identifiers

RxCUI
2286275 2286281 2286283 2286285 2286288 2286290
UNII
Y6581YAW9V

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name isturisa (source: ndc)
Generic Name osilodrostat (source: ndc)
Application Number NDA212801 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 20 TABLET, COATED in 1 BLISTER PACK (55292-330-20)
  • 60 TABLET, COATED in 1 BLISTER PACK (55292-330-60)
source: ndc

Packages (2)

55292-330-20 20 TABLET, COATED in 1 BLISTER PACK (55292-330-20) 55292-330-60 60 TABLET, COATED in 1 BLISTER PACK (55292-330-60)

Ingredients (1)

osilodrostat phosphate (1 mg/1)

Linked Drug Pages (1)

Isturisa ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "5c1e5bfa-9d7b-4a4a-b030-caf7bb57c6df", "openfda": {"unii": ["Y6581YAW9V"], "rxcui": ["2286275", "2286281", "2286283", "2286285", "2286288", "2286290"], "spl_set_id": ["f3a5ec24-63c3-4d83-b1c0-6c550fbe7ae2"], "manufacturer_name": ["Recordati Rare Diseases, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET, COATED in 1 BLISTER PACK (55292-330-20)", "package_ndc": "55292-330-20", "marketing_start_date": "20251103"}, {"sample": false, "description": "60 TABLET, COATED in 1 BLISTER PACK (55292-330-60)", "package_ndc": "55292-330-60", "marketing_start_date": "20251103"}], "brand_name": "Isturisa", "product_id": "55292-330_5c1e5bfa-9d7b-4a4a-b030-caf7bb57c6df", "dosage_form": "TABLET, COATED", "pharm_class": ["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]"], "product_ndc": "55292-330", "generic_name": "Osilodrostat", "labeler_name": "Recordati Rare Diseases, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Isturisa", "active_ingredients": [{"name": "OSILODROSTAT PHOSPHATE", "strength": "1 mg/1"}], "application_number": "NDA212801", "marketing_category": "NDA", "marketing_start_date": "20200331", "listing_expiration_date": "20261231"}