🇺🇸
United States · US · US:63020-210_692e8d28-13e4-43ae-8ea9-f2de3bc73d06
Fruzaqla
Orange BookUNIISPLATC L01EK04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTakeda Pharmaceuticals America, Inc.
CountryUS (United States)
ATC codeL01EK04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1163020210211 BOTTLE in 1 CARTON (63020-210-21) / 21 CAPSULE in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
49DXG3M5ZW
FRUQUINTINIB
Orange Book
N217564
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "49DXG3M5ZW",
"rxcui": null,
"inchikey": "BALLNEJQLSTPIO-UHFFFAOYSA-N",
"display_name": "FRUQUINTINIB",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"186d786e-dc8a-45f2-b5e1-01ac0201879f": {
"match": "brand_token",
"title": "FRUZAQLA (FRUQUINTINIB) CAPSULE [TAKEDA PHARMACEUTICALS AMERICA, INC.]",
"spl_version": "6",
"published_date": "2026-02-24"
}
},
"productid": "63020-210_692e8d28-13e4-43ae-8ea9-f2de3bc73d06",
"productndc": "63020-210",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "217564",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "1MG",
"product_no": "001",
"approval_date": "Nov 8, 2023"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "5MG",
"product_no": "002",
"approval_date": "Nov 8, 2023"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FRUQUINTINIB",
"proprietary_name": "Fruzaqla",
"active_ingred_unit": "mg/1",
"application_number": "NDA217564",
"marketing_category": "NDA",
"nonproprietary_name": "fruquintinib",
"start_marketing_date": "20231108",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code L01EK04.
- 🇨🇭FruzaqlaTakeda Pharma AG
- 🇺🇸FruzaqlaTakeda Pharmaceuticals America, Inc.
- ISFruzaqlaTakeda Pharmaceuticals International AG Ireland Branch
- PLFruzaqlaTakeda Pharmaceuticals International AG Ireland Branch
- 🇨🇭FruzaqlaTakeda Pharma AG
- ISFruzaqlaTakeda Pharmaceuticals International AG Ireland Branch
- PLFruzaqlaTakeda Pharmaceuticals International AG Ireland Branch
- NOFruzaqlaTakeda Pharmaceuticals International AG Ireland Branch
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