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United States · US · US:50090-3625_555f1ee6-225c-4834-b936-cdad8f836f81
Xarelto
Orange BookUNIISPLATC B01AF01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeB01AF01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11500903625090 TABLET, FILM COATED in 1 BOTTLE (50090-3625-0)
- ndc11500903625112 TABLET, FILM COATED in 1 BOTTLE (50090-3625-1)
Annotations
UNII (FDA Substance ID)
9NDF7JZ4M3
RIVAROXABAN
RxCUI 1114195
Orange Book
N022406
ABABABAB
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": "50090-3625_555f1ee6-225c-4834-b936-cdad8f836f81",
"productndc": "50090-3625",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "022406",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Jul 1, 2011"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "15MG",
"product_no": "002",
"approval_date": "Nov 4, 2011"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "20MG",
"product_no": "003",
"approval_date": "Nov 4, 2011"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "2.5MG",
"product_no": "004",
"approval_date": "Oct 11, 2018"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "RIVAROXABAN",
"proprietary_name": "Xarelto",
"active_ingred_unit": "mg/1",
"application_number": "NDA022406",
"marketing_category": "NDA",
"nonproprietary_name": "rivaroxaban",
"start_marketing_date": "20110701",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code B01AF01.
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