Isturisa
- Product NDC
- 55292-321
- 11-digit product format
- 552920321
- Labeler code
- 55292
- Product ID
- 55292-321_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
- Marketing end
- 2029-12-31
- 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
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Isturisa
Active Ingredients#
| Ingredient | Strength |
|---|---|
| OSILODROSTAT PHOSPHATE | 5 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | Y6581YAW9V |
| Rxcui | 2286275, 2286281, 2286283, 2286285, 2286288, 2286290 |
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 |
|---|---|---|---|---|---|---|
| 55292-321-20 | Isturisa | 20 in 1 BLISTER PACK | TABLET, COATED | 20 | 10 | |
| 55292-321-60 | 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 |
|---|---|---|---|---|---|
| 55292-321-20 | EA - Each | 55292-321 | 0a09605c-e038-473c-a3a2-f9f2456aea3b | 1 | 2020-05-08 |
| 55292-321-60 | EA - Each | 55292-321 | 99319356-67ae-47bb-9b3d-1cd3393654a2 | 1 | 2020-05-08 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55292-321 | ISTURISA (OSILODROSTAT) TABLET, COATED ISTURISA (OSILODROSTAT) TABLET, COATED ISTURISA (OSILODROSTAT) TABLET, COATED [RECORDATI RARE DISEASES, INC.] | 7 | Current NDC, 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 |
|---|---|---|---|---|---|---|---|
| 55292-321-20 | 55292032120 | 20 TABLET, COATED in 1 BLISTER PACK (55292-321-20) | 2020-03-31 | 2029-12-31 | No | No | Current |
| 55292-321-60 | 55292032160 | 60 TABLET, COATED in 1 BLISTER PACK (55292-321-60) | 2020-03-31 | 2029-12-31 | No | No | Current |