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United States · US · US:63020-090_176eb255-05c0-4cfc-874f-1fb57136d34d
Alunbrig
Orange BookUNIISPLATC L01ED04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTakeda Pharmaceuticals America, Inc.
CountryUS (United States)
ATC codeL01ED04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1163020090077 TABLET, FILM COATED in 1 BOTTLE (63020-090-07)
- ndc11630200903030 TABLET, FILM COATED in 1 BOTTLE (63020-090-30)
Annotations
UNII (FDA Substance ID)
HYW8DB273J
BRIGATINIB
RxCUI 1921217
Orange Book
N208772
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "HYW8DB273J",
"rxcui": "1921217",
"inchikey": "AILRADAXUVEEIR-UHFFFAOYSA-N",
"display_name": "BRIGATINIB",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"0fe9ff20-d402-41f3-bc1e-7002ea7007db": {
"match": "brand_token",
"title": "ALUNBRIG (BRIGATINIB) TABLET, FILM COATED ALUNBRIG (BRIGATINIB) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]",
"spl_version": "17",
"published_date": "2026-01-19"
}
},
"productid": "63020-090_176eb255-05c0-4cfc-874f-1fb57136d34d",
"productndc": "63020-090",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "208772",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "30MG",
"product_no": "001",
"approval_date": "Apr 28, 2017"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "90MG",
"product_no": "002",
"approval_date": "Apr 28, 2017"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "180MG",
"product_no": "003",
"approval_date": "Oct 2, 2017"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BRIGATINIB",
"proprietary_name": "Alunbrig",
"active_ingred_unit": "mg/1",
"application_number": "NDA208772",
"marketing_category": "NDA",
"nonproprietary_name": "brigatinib",
"start_marketing_date": "20170428",
"active_numerator_strength": "90"
}Related drugs
Other records sharing ATC code L01ED04.
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