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United States · US · US:0310-9500_78f077b9-49c8-47f6-8950-1799764a5dd4
TRUQAP
Orange BookUNIISPLATC L01EX27
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAstraZeneca Pharmaceuticals LP
CountryUS (United States)
ATC codeL01EX27
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11031095000164 TABLET, FILM COATED in 1 BOTTLE (0310-9500-01)
- ndc1103109500024 BLISTER PACK in 1 CARTON (0310-9500-02) / 16 TABLET, FILM COATED in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
WFR23M21IE
CAPIVASERTIB
Orange Book
N218197
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "WFR23M21IE",
"rxcui": null,
"inchikey": "JDUBGYFRJFOXQC-KRWDZBQOSA-N",
"display_name": "CAPIVASERTIB",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"d698c106-2322-401e-b738-cbd83c843ecf": {
"match": "brand_token",
"title": "TRUQAP (CAPIVASERTIB) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]",
"spl_version": "8",
"published_date": "2025-11-24"
}
},
"productid": "0310-9500_78f077b9-49c8-47f6-8950-1799764a5dd4",
"productndc": "0310-9500",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "218197",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "160MG",
"product_no": "001",
"approval_date": "Nov 16, 2023"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "200MG",
"product_no": "002",
"approval_date": "Nov 16, 2023"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CAPIVASERTIB",
"proprietary_name": "TRUQAP",
"active_ingred_unit": "mg/1",
"application_number": "NDA218197",
"marketing_category": "NDA",
"nonproprietary_name": "capivasertib",
"start_marketing_date": "20231116",
"active_numerator_strength": "160"
}Related drugs
Other records sharing ATC code L01EX27.
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