Prescription drug · NDA
Isturisa (Osilodrostat) NDC 55292-330
Osilodrostat phosphate 1 mg/1 · Tablet, Coated · Oral · Recordati Rare Diseases, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55292-330-20 | 55292033020 | 20 TABLET, COATED in 1 BLISTER PACK (55292-330-20)Marketed from Nov 3, 2025 | |
| 55292-330-60 | 55292033060 | 60 TABLET, COATED in 1 BLISTER PACK (55292-330-60)Marketed from Nov 3, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Isturisa
- Generic name (nonproprietary)
- osilodrostat
- Active ingredients
- Osilodrostat phosphate — 1 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- Recordati Rare Diseases, Inc.NDC labeler code 55292
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 212801
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 11B1 Inhibitors (Mechanism)Cytochrome P450 1A2 Inhibitors (Mechanism)Cytochrome P450 2C19 Inhibitors (Mechanism)Cytochrome P450 2D6 Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)Cytochrome P450 3A5 Inhibitors (Mechanism)
- Identifiers
- Product ID 55292-330_5c1e5bfa-9d7b-4a4a-b030-caf7bb57c6dfSPL ID 5c1e5bfa-9d7b-4a4a-b030-caf7bb57c6dfSPL set ID f3a5ec24-63c3-4d83-b1c0-6c550fbe7ae2RxCUI 2286275, 2286281, 2286283, 2286285, 2286288, 2286290UNII Y6581YAW9V
- Pharmacologic class
- Cortisol Synthesis Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N455292033020followed by a unit qualifier and the quantityPackage 55292-0330-20. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
ISTURISA is indicated for the treatment of endogenous hypercortisolemia in adults with Cushing's syndrome for whom surgery is not an option or has not been curative. ISTURISA is a cortisol synthesis inhibitor indicated for the treatment of endogenous hypercortisolemia in adults with Cushing's syndrome for whom surgery is not an option or has not been curative ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 55292-330
- What is NDC 55292-330?
- 55292-330 is the product NDC for Isturisa (osilodrostat), Osilodrostat phosphate 1 mg/1 tablet, coated, listed with the FDA by Recordati Rare Diseases, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Isturisa (Osilodrostat).
- What is the active ingredient?
- Osilodrostat phosphate.
- Who is the labeler?
- Recordati Rare Diseases, Inc., NDC labeler code 55292. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Isturisa?
- 3 other product NDCs are listed under this name. See all Isturisa NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Isturisa products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Isturisaosilodrostat | Osilodrostat phosphate 1 mg/1 | Tablet, CoatedOral | Recordati Rare Diseases, Inc. | 55292-320 | 55292-0320-2055292-0320-60 |
| Isturisaosilodrostat | Osilodrostat phosphate 5 mg/1 | Tablet, CoatedOral | Recordati Rare Diseases, Inc. | 55292-321 | 55292-0321-2055292-0321-60 |
| Isturisaosilodrostat | Osilodrostat phosphate 5 mg/1 | Tablet, CoatedOral | Recordati Rare Diseases, Inc. | 55292-331 | 55292-0331-2055292-0331-60 |
Other NDCs under NDA 212801
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Isturisaosilodrostat | Osilodrostat phosphate 1 mg/1 | Tablet, CoatedOral | Recordati Rare Diseases, Inc. | 55292-320 |
| Isturisaosilodrostat | Osilodrostat phosphate 5 mg/1 | Tablet, CoatedOral | Recordati Rare Diseases, Inc. | 55292-321 |
| Isturisaosilodrostat | Osilodrostat phosphate 5 mg/1 | Tablet, CoatedOral | Recordati Rare Diseases, Inc. | 55292-331 |