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United States · US · US:0173-0909_93e60116-b3f2-4568-ae12-03d6e016a953
ZEJULA
Orange BookUNIISPLATC L01XK02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGlaxoSmithKline LLC
CountryUS (United States)
ATC codeL01XK02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11017309091330 TABLET, FILM COATED in 1 BOTTLE (0173-0909-13)
Annotations
UNII (FDA Substance ID)
195Q483UZD
NIRAPARIB TOSYLATE
Orange Book
N214876
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "195Q483UZD",
"rxcui": null,
"inchikey": "ACNPUCQQZDAPJH-FMOMHUKBSA-N",
"display_name": "NIRAPARIB TOSYLATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"b7f675e2-159c-490c-b6f4-3f16d9492b7d": {
"match": "brand_token",
"title": "ZEJULA (NIRAPARIB) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]",
"spl_version": "9",
"published_date": "2026-04-06"
}
},
"productid": "0173-0909_93e60116-b3f2-4568-ae12-03d6e016a953",
"productndc": "0173-0909",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "214876",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 100MG BASE",
"product_no": "001",
"approval_date": "Apr 26, 2023"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 200MG BASE",
"product_no": "002",
"approval_date": "Apr 26, 2023"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 300MG BASE",
"product_no": "003",
"approval_date": "Apr 26, 2023"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NIRAPARIB TOSYLATE",
"proprietary_name": "ZEJULA",
"active_ingred_unit": "mg/1",
"application_number": "NDA214876",
"marketing_category": "NDA",
"nonproprietary_name": "niraparib",
"start_marketing_date": "20230627",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code L01XK02.
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