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United States · US · US:57962-007_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 · 1
- ndc1157962007121 BOTTLE, GLASS in 1 CARTON (57962-007-12) / 108 mL in 1 BOTTLE, GLASS
Annotations
UNII (FDA Substance ID)
1X70OSD4VX
IBRUTINIB
RxCUI 1442981
Orange Book
N217003
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": "57962-007_43280dcb-52ae-40e4-bd52-723f71f74ab7",
"productndc": "57962-007",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "217003",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "70MG/ML",
"product_no": "001",
"approval_date": "Aug 24, 2022"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "IBRUTINIB",
"proprietary_name": "Imbruvica",
"active_ingred_unit": "mg/mL",
"application_number": "NDA217003",
"marketing_category": "NDA",
"nonproprietary_name": "Ibrutinib",
"start_marketing_date": "20220824",
"active_numerator_strength": "70"
}Related drugs
Other records sharing ATC code L01EL01.
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