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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

  • ndc11
    0310950001
    64 TABLET, FILM COATED in 1 BOTTLE (0310-9500-01)
  • ndc11
    0310950002
    4 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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