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United States · US · US:71332-005_6df73356-e3c1-498d-af08-c34b5d257bdb
REZLIDHIA
Orange BookUNIISPLATC L01XM03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRigel Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeL01XM03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11713320050130 CAPSULE in 1 BOTTLE (71332-005-01)
Annotations
UNII (FDA Substance ID)
0T4IMT8S5Z
OLUTASIDENIB
RxCUI 2623641
Orange Book
N215814
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "0T4IMT8S5Z",
"rxcui": "2623641",
"inchikey": "NEQYWYXGTJDAKR-JTQLQIEISA-N",
"display_name": "OLUTASIDENIB",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"4a0c7c8b-b95f-455d-9600-b7351e4397fe": {
"match": "brand_token",
"title": "REZLIDHIA (OLUTASIDENIB) CAPSULE [RIGEL PHARMACEUTICALS, INC.]",
"spl_version": "5",
"published_date": "2025-11-17"
}
},
"productid": "71332-005_6df73356-e3c1-498d-af08-c34b5d257bdb",
"productndc": "71332-005",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "215814",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "150MG",
"product_no": "001",
"approval_date": "Dec 1, 2022"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "OLUTASIDENIB",
"proprietary_name": "REZLIDHIA",
"active_ingred_unit": "mg/1",
"application_number": "NDA215814",
"marketing_category": "NDA",
"nonproprietary_name": "olutasidenib",
"start_marketing_date": "20221201",
"active_numerator_strength": "150"
}Access this data programmatically
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