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United States · US · US:0310-0668_0142c57f-6211-4638-8c48-c215686871b8

Lynparza

Orange BookUNIISPLATC L01XK01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAstraZeneca Pharmaceuticals LP
CountryUS (United States)
ATC codeL01XK01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    0310066812
    120 TABLET, FILM COATED in 1 BOTTLE (0310-0668-12)
  • ndc11
    0310066860
    60 TABLET, FILM COATED in 1 BOTTLE (0310-0668-60)
  • ndc11
    0310066895
    60 TABLET, FILM COATED in 1 BOTTLE (0310-0668-95)

Annotations

UNII (FDA Substance ID)
WOH1JD9AR8
OLAPARIB
RxCUI 1597582
Orange Book
N208558
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "WOH1JD9AR8",
    "rxcui": "1597582",
    "inchikey": "FDLYAMZZIXQODN-UHFFFAOYSA-N",
    "display_name": "OLAPARIB",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "741ff3e3-dc1a-45a6-84e5-2481b27131aa": {
      "match": "brand_token",
      "title": "LYNPARZA (OLAPARIB) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]",
      "spl_version": "38",
      "published_date": "2025-07-25"
    }
  },
  "productid": "0310-0668_0142c57f-6211-4638-8c48-c215686871b8",
  "productndc": "0310-0668",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "208558",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Aug 17, 2017"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "150MG",
        "product_no": "002",
        "approval_date": "Aug 17, 2017"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OLAPARIB",
  "proprietary_name": "Lynparza",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA208558",
  "marketing_category": "NDA",
  "nonproprietary_name": "olaparib",
  "start_marketing_date": "20170817",
  "active_numerator_strength": "100"
}

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