Talzenna

Orange BookUNIISPLATC L01XK04

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerU.S. Pharmaceuticals

CountryUS (United States)

ATC codeL01XK04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6353903130
30 CAPSULE, LIQUID FILLED in 1 BOTTLE (63539-031-30)

Annotations

UNII (FDA Substance ID)

02WK9U5NZC

TALAZOPARIB TOSYLATE

RxCUI 2099703

Orange Book

N217439

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "02WK9U5NZC",
    "rxcui": "2099703",
    "inchikey": "QUQKKHBYEFLEHK-QNBGGDODSA-N",
    "display_name": "TALAZOPARIB TOSYLATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "c6fd147f-a77e-4a0b-9280-e82ecc41b4be": {
      "match": "brand_token",
      "title": "TALZENNA (TALAZOPARIB) CAPSULE, LIQUID FILLED [PFIZER LABORATORIES DIV PFIZER INC]",
      "spl_version": "4",
      "published_date": "2026-04-13"
    }
  },
  "productid": "63539-031_b653221e-971f-4452-92d4-797924f1ff59",
  "productndc": "63539-031",
  "dosage_form": "CAPSULE, LIQUID FILLED",
  "orange_book": {
    "appl_no": "217439",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.1MG BASE",
        "product_no": "001",
        "approval_date": "Mar 7, 2024"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.25MG BASE",
        "product_no": "002",
        "approval_date": "Mar 7, 2024"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.35MG BASE",
        "product_no": "003",
        "approval_date": "Mar 7, 2024"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.5MG BASE",
        "product_no": "004",
        "approval_date": "Mar 7, 2024"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.75MG BASE",
        "product_no": "005",
        "approval_date": "Mar 7, 2024"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 1MG BASE",
        "product_no": "006",
        "approval_date": "Mar 7, 2024"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TALAZOPARIB TOSYLATE",
  "proprietary_name": "Talzenna",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA217439",
  "marketing_category": "NDA",
  "nonproprietary_name": "talazoparib",
  "start_marketing_date": "20240709",
  "active_numerator_strength": "1"
}

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