🇺🇸
United States · US · US:47335-108_583fc0b7-67b8-48f2-8d31-127a5f370096
LEQSELVI
Orange BookUNIISPLATC L04AF
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeL04AF
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11473351088660 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (47335-108-86)
Annotations
UNII (FDA Substance ID)
8VJ43S4LCM
DEURUXOLITINIB PHOSPHATE
Orange Book
N217900
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "8VJ43S4LCM",
"rxcui": null,
"inchikey": "JFMWPOCYMYGEDM-NTVOUFPTSA-N",
"display_name": "DEURUXOLITINIB PHOSPHATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"a603f231-d09e-4bad-ad5e-b55f865da095": {
"match": "brand_token",
"title": "LEQSELVI (DEURUXOLITINIB PHOSPHATE) TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]",
"spl_version": "11",
"published_date": "2025-07-23"
}
},
"productid": "47335-108_583fc0b7-67b8-48f2-8d31-127a5f370096",
"productndc": "47335-108",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "217900",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 8MG BASE",
"product_no": "001",
"approval_date": "Jul 25, 2024"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DEURUXOLITINIB PHOSPHATE",
"proprietary_name": "LEQSELVI",
"active_ingred_unit": "mg/1",
"application_number": "NDA217900",
"marketing_category": "NDA",
"nonproprietary_name": "deuruxolitinib phosphate",
"start_marketing_date": "20250625",
"active_numerator_strength": "8"
}Related drugs
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