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United States · US · US:72579-011_cb0c9753-cca4-421e-9512-1b710a56b342
BRUKINSA
Orange BookUNIISPLATC L01EL03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBeOne Medicines USA, Inc.
CountryUS (United States)
ATC codeL01EL03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1172579011021 BOTTLE, PLASTIC in 1 CARTON (72579-011-02) / 120 CAPSULE in 1 BOTTLE, PLASTIC
Annotations
UNII (FDA Substance ID)
AG9MHG098Z
ZANUBRUTINIB
RxCUI 2262435
Orange Book
N213217
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "AG9MHG098Z",
"rxcui": "2262435",
"inchikey": "RNOAOAWBMHREKO-QFIPXVFZSA-N",
"display_name": "ZANUBRUTINIB",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"3e08fe23-d70e-424c-bc51-1222e320f902": {
"match": "brand_token",
"title": "BRUKINSA (ZANUBRUTINIB) CAPSULE BRUKINSA (ZANUBRUTINIB) TABLET, FILM COATED [BEONE MEDICINES USA, INC.]",
"spl_version": "22",
"published_date": "2026-02-03"
}
},
"productid": "72579-011_cb0c9753-cca4-421e-9512-1b710a56b342",
"productndc": "72579-011",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "213217",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "80MG",
"product_no": "001",
"approval_date": "Nov 14, 2019"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ZANUBRUTINIB",
"proprietary_name": "BRUKINSA",
"active_ingred_unit": "mg/1",
"application_number": "NDA213217",
"marketing_category": "NDA",
"nonproprietary_name": "zanubrutinib",
"start_marketing_date": "20191114",
"active_numerator_strength": "80"
}Related drugs
Other records sharing ATC code L01EL03.
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