Isturisa
- Product NDC
- 55292-331
- 11-digit product format
- 552920331
- Labeler code
- 55292
- Product ID
- 55292-331_5c1e5bfa-9d7b-4a4a-b030-caf7bb57c6df
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Osilodrostat
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Recordati Rare Diseases, Inc.
- Application
- NDA212801
- Marketing category
- NDA
- Marketing start
- 2020-03-31
- Substance
- OSILODROSTAT PHOSPHATE
- Active strength
- 5 mg/1
- Pharmacologic 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]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| Y6581YAW9V | OSILODROSTAT PHOSPHATE | 1315449-72-9 | OSILODROSTAT PHOSPHATE |
| 5YL4IQ1078 | OSILODROSTAT | 928134-65-0 | Osilodrostat |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 55292-331-20 | 55292033120 | 20 TABLET, COATED in 1 BLISTER PACK (55292-331-20) | 2025-11-03 | No | No | Historical |
| 55292-331-60 | 55292033160 | 60 TABLET, COATED in 1 BLISTER PACK (55292-331-60) | 2025-11-03 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Isturisa | Recordati Rare Diseases, Inc. | Novartis Pharma Stein AG | 2025-11-18 | HUMAN PRESCRIPTION DRUG LABEL | 10 |