🇺🇸
United States · US · US:50458-575_452610f0-5abb-448d-a1fc-9dd9be02bb66
Xarelto
Orange BookUNIISPLATC B01AF01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerJanssen Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeB01AF01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1150458575011 BOTTLE in 1 CARTON (50458-575-01) / 1 GRANULE, FOR SUSPENSION in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
9NDF7JZ4M3
RIVAROXABAN
RxCUI 1114195
Orange Book
N215859
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "9NDF7JZ4M3",
"rxcui": "1114195",
"inchikey": "KGFYHTZWPPHNLQ-AWEZNQCLSA-N",
"display_name": "RIVAROXABAN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"10db92f9-2300-4a80-836b-673e1ae91610": {
"match": "brand_token",
"title": "XARELTO (RIVAROXABAN) TABLET, FILM COATED XARELTO (RIVAROXABAN) TABLET, FILM COATED XARELTO (RIVAROXABAN) KIT XARELTO (RIVAROXABAN) GRANULE, FOR SUSPENSION [JANSSEN PHARMACEUTICALS, INC.]",
"spl_version": "64",
"published_date": "2026-04-06"
}
},
"productid": "50458-575_452610f0-5abb-448d-a1fc-9dd9be02bb66",
"productndc": "50458-575",
"dosage_form": "GRANULE, FOR SUSPENSION",
"orange_book": {
"appl_no": "215859",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "1MG/ML",
"product_no": "001",
"approval_date": "Dec 20, 2021"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "RIVAROXABAN",
"proprietary_name": "Xarelto",
"active_ingred_unit": "mg/1",
"application_number": "NDA215859",
"marketing_category": "NDA",
"nonproprietary_name": "rivaroxaban",
"start_marketing_date": "20211201",
"active_numerator_strength": "155"
}Related drugs
Other records sharing ATC code B01AF01.
Access this data programmatically
Query Xarelto and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.