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United States · US · US:72694-728_a5229004-7c72-421b-a4ea-2830ee872d20
VORANIGO
Orange BookUNIISPLATC L01XM04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerServier Pharmaceuticals LLC
CountryUS (United States)
ATC codeL01XM04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1172694728401 BOTTLE in 1 CARTON (72694-728-40) / 30 TABLET, FILM COATED in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
789Q85GA8P
VORASIDENIB
Orange Book
N218784
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "789Q85GA8P",
"rxcui": null,
"inchikey": "QCZAWDGAVJMPTA-RNFRBKRXSA-N",
"display_name": "VORASIDENIB",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"31405fee-55b7-4857-987e-2724ee76be84": {
"match": "brand_token",
"title": "VORANIGO (VORASIDENIB) TABLET, FILM COATED [SERVIER PHARMACEUTICALS LLC]",
"spl_version": "4",
"published_date": "2025-04-10"
}
},
"productid": "72694-728_a5229004-7c72-421b-a4ea-2830ee872d20",
"productndc": "72694-728",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "218784",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "10MG",
"product_no": "001",
"approval_date": "Aug 6, 2024"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "40MG",
"product_no": "002",
"approval_date": "Aug 6, 2024"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "VORASIDENIB",
"proprietary_name": "VORANIGO",
"active_ingred_unit": "mg/1",
"application_number": "NDA218784",
"marketing_category": "NDA",
"nonproprietary_name": "vorasidenib",
"start_marketing_date": "20240807",
"active_numerator_strength": "40"
}Related drugs
Other records sharing ATC code L01XM04.
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