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NDC 55292-0322-60 Isturisa 10 mg/1 Details
Isturisa 10 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 | 55292-0322 |
|---|---|
| Product ID | 55292-322_a135c232-1745-6ff6-e053-2a95a90acef1 |
| Associated GPIs | 30022060600340 |
| GCN Sequence Number | 080816 |
| GCN Sequence Number Description | osilodrostat phosphate TABLET 10 MG ORAL |
| HIC3 | P1G |
| HIC3 Description | ADRENAL STEROID INHIBITORS |
| GCN | 47795 |
| 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 | 10 |
| Active Ingredient Units | mg/1 |
| Substance Name | OSILODROSTAT PHOSPHATE |
| Labeler Name | Recordati Rare Diseases, Inc. |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA212801 |
| Listing Certified Through | 2022-12-31 |
Package
NDC 55292-0322-60 (55292032260)
| NDC Package Code | 55292-322-60 |
|---|---|
| Billing NDC | 55292032260 |
| Package | 60 TABLET, COATED in 1 BLISTER PACK (55292-322-60) |
| Marketing Start Date | 2020-03-31 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |