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United States · US · US:65597-407_00774850-56e9-4fb9-85e8-586967a9a5f1
Turalio
Orange BookUNIISPLATC L01EX15
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDaiichi Sankyo Inc.
CountryUS (United States)
ATC codeL01EX15
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1165597407201 BOTTLE in 1 CARTON (65597-407-20) / 120 CAPSULE in 1 BOTTLE
- ndc1165597407281 BOTTLE in 1 CARTON (65597-407-28) / 28 CAPSULE in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
YS6WAI3XN7
PEXIDARTINIB HYDROCHLORIDE
RxCUI 2183103
Orange Book
N211810
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "YS6WAI3XN7",
"rxcui": "2183103",
"inchikey": "CJLUYLRKLUYCEK-UHFFFAOYSA-N",
"display_name": "PEXIDARTINIB HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"7b0ec4bf-b2ac-49ee-96af-7740ad3f2e16": {
"match": "brand_token",
"title": "TURALIO (PEXIDARTINIB HYDROCHLORIDE) CAPSULE [DAIICHI SANKYO INC.]",
"spl_version": "8",
"published_date": "2025-01-20"
}
},
"productid": "65597-407_00774850-56e9-4fb9-85e8-586967a9a5f1",
"productndc": "65597-407",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "211810",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 200MG BASE",
"product_no": "001",
"approval_date": "Aug 2, 2019"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 125MG BASE",
"product_no": "002",
"approval_date": "Oct 14, 2022"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PEXIDARTINIB HYDROCHLORIDE",
"proprietary_name": "Turalio",
"active_ingred_unit": "mg/1",
"application_number": "NDA211810",
"marketing_category": "NDA",
"nonproprietary_name": "pexidartinib hydrochloride",
"start_marketing_date": "20230201",
"active_numerator_strength": "125"
}Access this data programmatically
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