🇺🇸
United States · US · US:65597-504_ee05ebbe-cace-4b2f-bb89-c26687c1eeaf
VANFLYTA
Orange BookUNIISPLATC L01EX11
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDaiichi Sankyo Inc.
CountryUS (United States)
ATC codeL01EX11
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1165597504041 BOTTLE in 1 CARTON (65597-504-04) / 14 TABLET, FILM COATED in 1 BOTTLE
- ndc1165597504281 BOTTLE in 1 CARTON (65597-504-28) / 28 TABLET, FILM COATED in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
WK7Q6ZIZ10
QUIZARTINIB DIHYDROCHLORIDE
Orange Book
N216993
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "WK7Q6ZIZ10",
"rxcui": null,
"inchikey": "DHYPGRVMIOATAE-UHFFFAOYSA-N",
"display_name": "QUIZARTINIB DIHYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"29cdbcfe-497d-4e78-bb7b-2d4acafe8e86": {
"match": "brand_token",
"title": "VANFLYTA (QUIZARTINIB) TABLET, FILM COATED [DAIICHI SANKYO INC.]",
"spl_version": "11",
"published_date": "2026-04-22"
}
},
"productid": "65597-504_ee05ebbe-cace-4b2f-bb89-c26687c1eeaf",
"productndc": "65597-504",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "216993",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 17.7MG BASE",
"product_no": "001",
"approval_date": "Jul 20, 2023"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 26.5MG BASE",
"product_no": "002",
"approval_date": "Jul 20, 2023"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "QUIZARTINIB DIHYDROCHLORIDE",
"proprietary_name": "VANFLYTA",
"active_ingred_unit": "mg/1",
"application_number": "NDA216993",
"marketing_category": "NDA",
"nonproprietary_name": "QUIZARTINIB",
"start_marketing_date": "20230720",
"active_numerator_strength": "17.7"
}Related drugs
Other records sharing ATC code L01EX11.
Access this data programmatically
Query VANFLYTA and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.