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NDC 55292-0321-60 Isturisa 5 mg/1 Details
Isturisa 5 mg/1
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 Information
| NDC | 55292-0321 |
|---|---|
| Product ID | 55292-321_10dfb430-b311-4afe-9f28-e8cb47aa629a |
| Associated GPIs | 30022060600330 |
| GCN Sequence Number | 080815 |
| GCN Sequence Number Description | osilodrostat phosphate TABLET 5 MG ORAL |
| HIC3 | P1G |
| HIC3 Description | ADRENAL STEROID INHIBITORS |
| GCN | 47794 |
| HICL Sequence Number | 046396 |
| HICL Sequence Number Description | OSILODROSTAT PHOSPHATE |
| Brand/Generic | Brand |
| Proprietary Name | Isturisa |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Osilodrostat |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, COATED |
| Route | ORAL |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mg/1 |
| Substance Name | OSILODROSTAT PHOSPHATE |
| Labeler Name | Recordati Rare Diseases, Inc. |
| Pharmaceutical Class | 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 Inhibit |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA212801 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 55292-0321-60 (55292032160)
| NDC Package Code | 55292-321-60 |
|---|---|
| Billing NDC | 55292032160 |
| Package | 60 TABLET, COATED in 1 BLISTER PACK (55292-321-60) |
| Marketing Start Date | 2020-03-31 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |