NDC 55292-321
Isturisa
Osilodrostat
Isturisa is a Oral Tablet, Coated in the Human Prescription Drug category. It is labeled and distributed by Recordati Rare Diseases, Inc.. The primary component is Osilodrostat Phosphate.
| Product ID | 55292-321_06e491a0-5048-424a-9fa3-5109679d7908 |
| NDC | 55292-321 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Isturisa |
| Generic Name | Osilodrostat |
| Dosage Form | Tablet, Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2020-03-31 |
| Marketing Category | NDA / NDA |
| Application Number | NDA212801 |
| Labeler Name | Recordati Rare Diseases, Inc. |
| Substance Name | OSILODROSTAT PHOSPHATE |
| Active Ingredient Strength | 5 mg/1 |
| Pharm 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 | N |
| Listing Certified Through | 2024-12-31 |
Packaging
NDC 55292-321-20
20 TABLET, COATED in 1 BLISTER PACK (55292-321-20)
| Marketing Start Date | 2020-03-31 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 55292-321-60 [55292032160]
Isturisa TABLET, COATED
| Marketing Category | NDA |
| Application Number | NDA212801 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2020-03-31 |
NDC 55292-321-20 [55292032120]
Isturisa TABLET, COATED
| Marketing Category | NDA |
| Application Number | NDA212801 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2020-03-31 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| OSILODROSTAT PHOSPHATE | 5 mg/1 |
OpenFDA Data
| SPL SET ID: | f3a5ec24-63c3-4d83-b1c0-6c550fbe7ae2 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
NDC Crossover Matching brand name "Isturisa" or generic name "Osilodrostat"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 55292-320 | Isturisa | Osilodrostat |
| 55292-321 | Isturisa | Osilodrostat |
| 55292-322 | Isturisa | Osilodrostat |
Trademark Results [Isturisa]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ISTURISA 79187535 5061675 Live/Registered |
NOVARTIS AG 2016-03-30 |
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