Isturisa
- Product NDC
- 55292-322
- 11-digit product format
- 552920322
- Labeler code
- 55292
- Product ID
- 55292-322_06e491a0-5048-424a-9fa3-5109679d7908
- 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
- Marketing end
- 0000-00-00
- Substance
- OSILODROSTAT PHOSPHATE
- Active strength
- 10 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
- 2024-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e84c7901-5467-4923-8689-3c818af16a20 | Product name | 1 | 20200416 |
| b24d4793-65b6-4af9-9458-71c74807c5cb | Product name | 1 | 20200330 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55292-322-20 | Isturisa | 20 in 1 BLISTER PACK | TABLET, COATED | 20 | 10 | |
| 55292-322-60 | Isturisa | 60 in 1 BLISTER PACK | TABLET, COATED | 60 | 10 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 55292-322-20 | EA - Each | 55292-322 | 6ee0f7a9-4372-411a-8452-fd60e670ac58 | 1 | 2020-05-08 |
| 55292-322-60 | EA - Each | 55292-322 | f822646d-be0d-4b23-b30f-47abec1412d4 | 1 | 2020-05-08 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55292-322 | ISTURISA (OSILODROSTAT) TABLET, COATED ISTURISA (OSILODROSTAT) TABLET, COATED ISTURISA (OSILODROSTAT) TABLET, COATED [RECORDATI RARE DISEASES, INC.] | 7 | Legacy NDC, 2 package rows | 20250430_f3a5ec24-63c3-4d83-b1c0-6c550fbe7ae2.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2286281 | Isturisa 1 MG Oral Tablet | PSN | f3a5ec24-63c3-4d83-b1c0-6c550fbe7ae2 | 10 |
| 2286285 | Isturisa 10 MG Oral Tablet | PSN | f3a5ec24-63c3-4d83-b1c0-6c550fbe7ae2 | 10 |
| 2286290 | Isturisa 5 MG Oral Tablet | PSN | f3a5ec24-63c3-4d83-b1c0-6c550fbe7ae2 | 10 |
| 2286275 | osilodrostat 1 MG Oral Tablet | PSN | f3a5ec24-63c3-4d83-b1c0-6c550fbe7ae2 | 10 |
| 2286283 | osilodrostat 10 MG Oral Tablet | PSN | f3a5ec24-63c3-4d83-b1c0-6c550fbe7ae2 | 10 |
| 2286288 | osilodrostat 5 MG Oral Tablet | PSN | f3a5ec24-63c3-4d83-b1c0-6c550fbe7ae2 | 10 |
| 2286281 | osilodrostat 1 MG Oral Tablet [Isturisa] | SBD | f3a5ec24-63c3-4d83-b1c0-6c550fbe7ae2 | 10 |
| 2286285 | osilodrostat 10 MG Oral Tablet [Isturisa] | SBD | f3a5ec24-63c3-4d83-b1c0-6c550fbe7ae2 | 10 |
| 2286290 | osilodrostat 5 MG Oral Tablet [Isturisa] | SBD | f3a5ec24-63c3-4d83-b1c0-6c550fbe7ae2 | 10 |
| 2286275 | osilodrostat 1 MG Oral Tablet | SCD | f3a5ec24-63c3-4d83-b1c0-6c550fbe7ae2 | 10 |
| 2286283 | osilodrostat 10 MG Oral Tablet | SCD | f3a5ec24-63c3-4d83-b1c0-6c550fbe7ae2 | 10 |
| 2286288 | osilodrostat 5 MG Oral Tablet | SCD | f3a5ec24-63c3-4d83-b1c0-6c550fbe7ae2 | 10 |
| 2286281 | Isturisa 1 MG (as osilodrostat phosphate 1.4 MG) Oral Tablet | SY | f3a5ec24-63c3-4d83-b1c0-6c550fbe7ae2 | 10 |
| 2286281 | Isturisa 1 MG Oral Tablet | SY | f3a5ec24-63c3-4d83-b1c0-6c550fbe7ae2 | 10 |
| 2286285 | Isturisa 10 MG (as osilodrostat phosphate 14.3 MG) Oral Tablet | SY | f3a5ec24-63c3-4d83-b1c0-6c550fbe7ae2 | 10 |
| 2286285 | Isturisa 10 MG Oral Tablet | SY | f3a5ec24-63c3-4d83-b1c0-6c550fbe7ae2 | 10 |
| 2286290 | Isturisa 5 MG (as osilodrostat phosphate 7.2 MG) Oral Tablet | SY | f3a5ec24-63c3-4d83-b1c0-6c550fbe7ae2 | 10 |
| 2286290 | Isturisa 5 MG Oral Tablet | SY | f3a5ec24-63c3-4d83-b1c0-6c550fbe7ae2 | 10 |
| 2286275 | osilodrostat 1 MG (as osilodrostat phosphate 1.4 MG) Oral Tablet | SY | f3a5ec24-63c3-4d83-b1c0-6c550fbe7ae2 | 10 |
| 2286283 | osilodrostat 10 MG (as osilodrostat phosphate 14.3 MG) Oral Tablet | SY | f3a5ec24-63c3-4d83-b1c0-6c550fbe7ae2 | 10 |
| 2286288 | osilodrostat 5 MG (as osilodrostat phosphate 7.2 MG) Oral Tablet | SY | f3a5ec24-63c3-4d83-b1c0-6c550fbe7ae2 | 10 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 55292-322-20 | 55292032220 | 20 TABLET, COATED in 1 BLISTER PACK (55292-322-20) | 2020-03-31 | 0000-00-00 | No | No | Current |
| 55292-322-60 | 55292032260 | 60 TABLET, COATED in 1 BLISTER PACK (55292-322-60) | 2020-03-31 | 0000-00-00 | No | No | Current |