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United States · US · US:63539-336_0043f6db-decd-4d53-a301-35f2f7a63664
CIBINQO
Orange BookUNIISPLATC D11AH08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerU.S. Pharmaceuticals
CountryUS (United States)
ATC codeD11AH08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11635393361414 TABLET, FILM COATED in 1 BOTTLE (63539-336-14)
Annotations
UNII (FDA Substance ID)
73SM5SF3OR
ABROCITINIB
RxCUI 2591476
Orange Book
N213871
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "73SM5SF3OR",
"rxcui": "2591476",
"inchikey": "IUEWXNHSKRWHDY-PHIMTYICSA-N",
"display_name": "ABROCITINIB",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"16c12a56-4550-414b-ac9d-b785b41fea6b": {
"match": "brand_token",
"title": "CIBINQO (ABROCITINIB) TABLET, FILM COATED [U.S. PHARMACEUTICALS]",
"spl_version": "4",
"published_date": "2025-03-24"
}
},
"productid": "63539-336_0043f6db-decd-4d53-a301-35f2f7a63664",
"productndc": "63539-336",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "213871",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "50MG",
"product_no": "001",
"approval_date": "Jan 14, 2022"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "100MG",
"product_no": "002",
"approval_date": "Jan 14, 2022"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "200MG",
"product_no": "003",
"approval_date": "Jan 14, 2022"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ABROCITINIB",
"proprietary_name": "CIBINQO",
"active_ingred_unit": "mg/1",
"application_number": "NDA213871",
"marketing_category": "NDA",
"nonproprietary_name": "abrocitinib",
"start_marketing_date": "20220224",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code D11AH08.
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