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United States · US · US:82154-0783_473a8026-e822-2a9e-e063-6294a90a5c06
Rubraca
Orange BookUNIISPLATC L01XK03
Last synced from FDA National Drug Code directory (United States) on
Identification
Manufacturerpharmaand GmbH
CountryUS (United States)
ATC codeL01XK03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11821540783160 TABLET, FILM COATED in 1 BOTTLE (82154-0783-1)
Annotations
UNII (FDA Substance ID)
41AX9SJ8KO
RUCAPARIB CAMSYLATE
RxCUI 1862578
Orange Book
N209115
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "41AX9SJ8KO",
"rxcui": "1862578",
"inchikey": "INBJJAFXHQQSRW-STOWLHSFSA-N",
"display_name": "RUCAPARIB CAMSYLATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"0295d202-1cfe-7659-e063-6294a90a476e": {
"match": "brand_token",
"title": "RUBRACA (RUCAPARIB) TABLET, FILM COATED [PHARMAAND GMBH]",
"spl_version": "19",
"published_date": "2026-01-02"
}
},
"productid": "82154-0783_473a8026-e822-2a9e-e063-6294a90a5c06",
"productndc": "82154-0783",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "209115",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 200MG BASE",
"product_no": "001",
"approval_date": "Dec 19, 2016"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 300MG BASE",
"product_no": "002",
"approval_date": "Dec 19, 2016"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 250MG BASE",
"product_no": "003",
"approval_date": "May 1, 2017"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "RUCAPARIB CAMSYLATE",
"proprietary_name": "Rubraca",
"active_ingred_unit": "mg/1",
"application_number": "NDA209115",
"marketing_category": "NDA",
"nonproprietary_name": "rucaparib",
"start_marketing_date": "20161219",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code L01XK03.
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