🇺🇸
United States · US · US:72694-617_190606ed-cb7f-411b-8548-cc2f98e57819
TIBSOVO
Orange BookUNIISPLATC L01XM02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerServier Pharmaceutical LLC
CountryUS (United States)
ATC codeL01XM02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1172694617601 BOTTLE in 1 CARTON (72694-617-60) / 60 TABLET, FILM COATED in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
Q2PCN8MAM6
IVOSIDENIB
RxCUI 2049873
Orange Book
N211192
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "Q2PCN8MAM6",
"rxcui": "2049873",
"inchikey": "WIJZXSAJMHAVGX-DHLKQENFSA-N",
"display_name": "IVOSIDENIB",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"65d254c0-67ad-42c4-b972-ad463b755b2d": {
"match": "brand_token",
"title": "TIBSOVO (IVOSIDENIB) TABLET, FILM COATED [SERVIER PHARMACEUTICAL LLC]",
"spl_version": "11",
"published_date": "2025-12-22"
}
},
"productid": "72694-617_190606ed-cb7f-411b-8548-cc2f98e57819",
"productndc": "72694-617",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "211192",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "250MG",
"product_no": "001",
"approval_date": "Jul 20, 2018"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "IVOSIDENIB",
"proprietary_name": "TIBSOVO",
"active_ingred_unit": "mg/1",
"application_number": "NDA211192",
"marketing_category": "NDA",
"nonproprietary_name": "ivosidenib",
"start_marketing_date": "20211019",
"active_numerator_strength": "250"
}Related drugs
Other records sharing ATC code L01XM02.
- FITibsovoLes Laboratoires Servier
- DKTibsovoLes Laboratoires Servier
- PLTibsovoLes Laboratoires Servier
- NOTibsovoLes Laboratoires Servier
- ISTibsovoLes Laboratoires Servier*
- CZTIBSOVOLes Laboratoires Servier, Suresnes cedex
- BETibsovo 250 mgLes Laboratoires Servier
- IETibsovo 250 mg Film-coated tabletLes Laboratoires Servier
Access this data programmatically
Query TIBSOVO 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.