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United States · US · US:59572-705_32634006-49db-4043-b84b-65f7f54b142d
Idhifa
Orange BookUNIISPLATC L01XM01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCelgene Corporation
CountryUS (United States)
ATC codeL01XM01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11595727053030 TABLET, FILM COATED in 1 BOTTLE (59572-705-30)
Annotations
UNII (FDA Substance ID)
UF6PC17XAV
ENASIDENIB MESYLATE
RxCUI 1940331
Orange Book
N209606
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "UF6PC17XAV",
"rxcui": "1940331",
"inchikey": "ORZHZQZYWXEDDL-UHFFFAOYSA-N",
"display_name": "ENASIDENIB MESYLATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"a5b4cdf0-3fa8-4c6c-80f6-8d8a00e3a5b6": {
"match": "brand_token",
"title": "IDHIFA (ENASIDENIB MESYLATE) TABLET, FILM COATED [CELGENE CORPORATION]",
"spl_version": "12",
"published_date": "2025-01-30"
}
},
"productid": "59572-705_32634006-49db-4043-b84b-65f7f54b142d",
"productndc": "59572-705",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "209606",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 50MG BASE",
"product_no": "001",
"approval_date": "Aug 1, 2017"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 100MG BASE",
"product_no": "002",
"approval_date": "Aug 1, 2017"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ENASIDENIB MESYLATE",
"proprietary_name": "Idhifa",
"active_ingred_unit": "mg/1",
"application_number": "NDA209606",
"marketing_category": "NDA",
"nonproprietary_name": "enasidenib mesylate",
"start_marketing_date": "20170801",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code L01XM01.
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