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United States · US · US:57962-140_43280dcb-52ae-40e4-bd52-723f71f74ab7
Imbruvica
Orange BookUNIISPLATC L01EL01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPharmacyclics LLC
CountryUS (United States)
ATC codeL01EL01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11579621400990 CAPSULE in 1 BOTTLE, PLASTIC (57962-140-09)
- ndc115796214012120 CAPSULE in 1 BOTTLE, PLASTIC (57962-140-12)
Annotations
UNII (FDA Substance ID)
1X70OSD4VX
IBRUTINIB
RxCUI 1442981
Orange Book
N205552
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "1X70OSD4VX",
"rxcui": "1442981",
"inchikey": "XYFPWWZEPKGCCK-GOSISDBHSA-N",
"display_name": "IBRUTINIB",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"0dfd0279-ff17-4ea9-89be-9803c71bab44": {
"match": "brand_token",
"title": "IMBRUVICA (IBRUTINIB) CAPSULE IMBRUVICA (IBRUTINIB) TABLET, FILM COATED IMBRUVICA (IBRUTINIB) SUSPENSION [PHARMACYCLICS LLC]",
"spl_version": "65",
"published_date": "2026-01-08"
}
},
"productid": "57962-140_43280dcb-52ae-40e4-bd52-723f71f74ab7",
"productndc": "57962-140",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "205552",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "140MG",
"product_no": "001",
"approval_date": "Nov 13, 2013"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "70MG",
"product_no": "002",
"approval_date": "Dec 20, 2017"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "IBRUTINIB",
"proprietary_name": "Imbruvica",
"active_ingred_unit": "mg/1",
"application_number": "NDA205552",
"marketing_category": "NDA",
"nonproprietary_name": "Ibrutinib",
"start_marketing_date": "20131113",
"active_numerator_strength": "140"
}Related drugs
Other records sharing ATC code L01EL01.
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