🇺🇸
United States · US · US:45629-089_40222ff4-0ffc-318f-e063-6294a90aadc2
FOTIVDA
Orange BookUNIISPLATC L01EK03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAVEO Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeL01EK03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1145629089011 BOTTLE, PLASTIC in 1 BAG (45629-089-01) / 21 CAPSULE in 1 BOTTLE, PLASTIC
- ndc1145629089021 BOTTLE, PLASTIC in 1 CARTON (45629-089-02) / 21 CAPSULE in 1 BOTTLE, PLASTIC
Annotations
UNII (FDA Substance ID)
8A9H4VK35Z
TIVOZANIB HYDROCHLORIDE
RxCUI 2534245
Orange Book
N212904
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "8A9H4VK35Z",
"rxcui": "2534245",
"inchikey": "RQXMKRRBJITKRN-UHFFFAOYSA-N",
"display_name": "TIVOZANIB HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"de77155c-ecf2-4f15-9758-21d271449d83": {
"match": "brand_token",
"title": "FOTIVDA (TIVOZANIB) CAPSULE [AVEO PHARMACEUTICALS, INC.]",
"spl_version": "13",
"published_date": "2025-10-06"
}
},
"productid": "45629-089_40222ff4-0ffc-318f-e063-6294a90aadc2",
"productndc": "45629-089",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "212904",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 0.89MG BASE",
"product_no": "001",
"approval_date": "Mar 10, 2021"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 1.34MG BASE",
"product_no": "002",
"approval_date": "Mar 10, 2021"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TIVOZANIB HYDROCHLORIDE",
"proprietary_name": "FOTIVDA",
"active_ingred_unit": "mg/1",
"application_number": "NDA212904",
"marketing_category": "NDA",
"nonproprietary_name": "Tivozanib",
"start_marketing_date": "20210310",
"active_numerator_strength": ".89"
}Related drugs
Other records sharing ATC code L01EK03.
Access this data programmatically
Query FOTIVDA 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.