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United States · US · US:0469-1425_b1aef238-5cd9-47cb-a83f-1f5eac49f013
Xospata
Orange BookUNIISPLATC L01EX13
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAstellas Pharma US, Inc.
CountryUS (United States)
ATC codeL01EX13
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1104691425211 BOTTLE in 1 CARTON (0469-1425-21) / 21 TABLET in 1 BOTTLE
- ndc1104691425901 BOTTLE in 1 CARTON (0469-1425-90) / 90 TABLET in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
5RZZ0Z1GJT
GILTERITINIB FUMARATE
RxCUI 2105823
Orange Book
N211349
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "5RZZ0Z1GJT",
"rxcui": "2105823",
"inchikey": "UJOUWHLYTQFUCU-WXXKFALUSA-N",
"display_name": "GILTERITINIB FUMARATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"b5ff59aa-9c0d-49a8-9053-1f179b482383": {
"match": "brand_token",
"title": "XOSPATA (GILTERITINIB) TABLET [ASTELLAS PHARMA US, INC.]",
"spl_version": "10",
"published_date": "2025-01-27"
}
},
"productid": "0469-1425_b1aef238-5cd9-47cb-a83f-1f5eac49f013",
"productndc": "0469-1425",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "211349",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 40MG BASE",
"product_no": "001",
"approval_date": "Nov 28, 2018"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GILTERITINIB FUMARATE",
"proprietary_name": "Xospata",
"active_ingred_unit": "mg/1",
"application_number": "NDA211349",
"marketing_category": "NDA",
"nonproprietary_name": "gilteritinib",
"start_marketing_date": "20181129",
"active_numerator_strength": "40"
}Related drugs
Other records sharing ATC code L01EX13.
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