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
6353905130
1 BOTTLE in 1 CARTON (63539-051-30) / 30 CAPSULE in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

02WK9U5NZC

TALAZOPARIB TOSYLATE

RxCUI 2099703

Orange Book

N211651

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": "63539-051_245347ef-49f2-4b24-9892-b43489562a46",
  "productndc": "63539-051",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "211651",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.25MG BASE",
        "product_no": "001",
        "approval_date": "Oct 16, 2018"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 1MG BASE",
        "product_no": "002",
        "approval_date": "Oct 16, 2018"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.5MG BASE",
        "product_no": "003",
        "approval_date": "Sep 20, 2021"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.75MG BASE",
        "product_no": "004",
        "approval_date": "Sep 20, 2021"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.1MG BASE",
        "product_no": "005",
        "approval_date": "Jun 20, 2023"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.35MG BASE",
        "product_no": "006",
        "approval_date": "Jun 20, 2023"
      }
    ],
    "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": "NDA211651",
  "marketing_category": "NDA",
  "nonproprietary_name": "talazoparib",
  "start_marketing_date": "20230621",
  "active_numerator_strength": ".5"
}

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