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United States · US · US:0310-4513_7365aa18-60da-4ce6-9c06-01c80e158286
CALQUENCE
Orange BookUNIISPLATC L01EL02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAstraZeneca Pharmaceuticals LP
CountryUS (United States)
ATC codeL01EL02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11031045136060 TABLET, FILM COATED in 1 BOTTLE (0310-4513-60)
Annotations
UNII (FDA Substance ID)
I42748ELQW
ACALABRUTINIB
RxCUI 1986808
Orange Book
N216387
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "I42748ELQW",
"rxcui": "1986808",
"inchikey": "WDENQIQQYWYTPO-IBGZPJMESA-N",
"display_name": "ACALABRUTINIB",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"dd4835ef-e1bc-4997-a399-1ffa2556fbfe": {
"match": "brand_token",
"title": "CALQUENCE (ACALABRUTINIB) CAPSULE, GELATIN COATED [ASTRAZENECA PHARMACEUTICALS LP]",
"spl_version": "27",
"published_date": "2026-03-05"
}
},
"productid": "0310-4513_7365aa18-60da-4ce6-9c06-01c80e158286",
"productndc": "0310-4513",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "216387",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 100MG BASE",
"product_no": "001",
"approval_date": "Aug 3, 2022"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ACALABRUTINIB",
"proprietary_name": "CALQUENCE",
"active_ingred_unit": "mg/1",
"application_number": "NDA216387",
"marketing_category": "NDA",
"nonproprietary_name": "acalabrutinib",
"start_marketing_date": "20220804",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code L01EL02.
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