🇺🇸
United States · US · US:84651-200_5154bda7-7ab4-4ad4-8fee-7fbe9ea692cc
IBTROZI
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNuvation Bio Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1184651200933 BOTTLE in 1 CARTON (84651-200-93) / 30 CAPSULE in 1 BOTTLE (84651-200-30)
Annotations
UNII (FDA Substance ID)
6KLL51GNBG
TALETRECTINIB ADIPATE
Orange Book
N219713
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "6KLL51GNBG",
"rxcui": null,
"inchikey": "DORJQZDOULKINH-QNBGGDODSA-N",
"display_name": "TALETRECTINIB ADIPATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"51ac8e52-3269-4102-8dc8-dba22d82128c": {
"match": "brand_token",
"title": "IBTROZI (TALETRECTINIB) CAPSULE [NUVATION BIO INC.]",
"spl_version": "4",
"published_date": "2026-04-06"
}
},
"productid": "84651-200_5154bda7-7ab4-4ad4-8fee-7fbe9ea692cc",
"productndc": "84651-200",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "219713",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 200MG BASE",
"product_no": "001",
"approval_date": "Jun 11, 2025"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TALETRECTINIB ADIPATE",
"proprietary_name": "IBTROZI",
"active_ingred_unit": "mg/1",
"application_number": "NDA219713",
"marketing_category": "NDA",
"nonproprietary_name": "taletrectinib",
"start_marketing_date": "20250611",
"active_numerator_strength": "272"
}Access this data programmatically
Query IBTROZI 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.