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United States · US · US:55292-321_5c1e5bfa-9d7b-4a4a-b030-caf7bb57c6df
Isturisa
Orange BookUNIISPLATC H02CA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRecordati Rare Diseases, Inc.
CountryUS (United States)
ATC codeH02CA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11552923212020 TABLET, COATED in 1 BLISTER PACK (55292-321-20)
- ndc11552923216060 TABLET, COATED in 1 BLISTER PACK (55292-321-60)
Annotations
UNII (FDA Substance ID)
Y6581YAW9V
OSILODROSTAT PHOSPHATE
RxCUI 2286253
Orange Book
N212801
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "Y6581YAW9V",
"rxcui": "2286253",
"inchikey": "FMCPYRDGUZBOJZ-BTQNPOSSSA-N",
"display_name": "OSILODROSTAT PHOSPHATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"f3a5ec24-63c3-4d83-b1c0-6c550fbe7ae2": {
"match": "brand_token",
"title": "ISTURISA (OSILODROSTAT) TABLET, COATED ISTURISA (OSILODROSTAT) TABLET, COATED ISTURISA (OSILODROSTAT) TABLET, COATED [RECORDATI RARE DISEASES, INC.]",
"spl_version": "10",
"published_date": "2025-11-19"
}
},
"productid": "55292-321_5c1e5bfa-9d7b-4a4a-b030-caf7bb57c6df",
"productndc": "55292-321",
"dosage_form": "TABLET, COATED",
"orange_book": {
"appl_no": "212801",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 1MG BASE",
"product_no": "001",
"approval_date": "Mar 6, 2020"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 5MG BASE",
"product_no": "002",
"approval_date": "Mar 6, 2020"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 10MG BASE",
"product_no": "003",
"approval_date": "Mar 6, 2020"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "OSILODROSTAT PHOSPHATE",
"proprietary_name": "Isturisa",
"active_ingred_unit": "mg/1",
"application_number": "NDA212801",
"marketing_category": "NDA",
"nonproprietary_name": "OSILODROSTAT",
"start_marketing_date": "20200331",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code H02CA02.
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