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United States · US · US:60505-6256_0e1a0098-1b42-db14-8e0f-23c8ee1e35cf
Rivaroxaban
Orange BookUNIISPLATC B01AF01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerApotex Corp.
CountryUS (United States)
ATC codeB01AF01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc116050562565500 TABLET, FILM COATED in 1 BOTTLE (60505-6256-5)
- ndc11605056256660 TABLET, FILM COATED in 1 BOTTLE (60505-6256-6)
Annotations
UNII (FDA Substance ID)
9NDF7JZ4M3
RIVAROXABAN
RxCUI 1114195
Orange Book
A217810
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": {
"925a9a11-ae5b-405c-96d2-b1be4b85bf71": {
"match": "brand_token",
"title": "RIVAROXABAN TABLET, COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]",
"spl_version": "15",
"published_date": "2026-05-28"
}
},
"productid": "60505-6256_0e1a0098-1b42-db14-8e0f-23c8ee1e35cf",
"productndc": "60505-6256",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "217810",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "2.5MG",
"product_no": "001",
"approval_date": "May 2, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "RIVAROXABAN",
"proprietary_name": "Rivaroxaban",
"active_ingred_unit": "mg/1",
"application_number": "ANDA217810",
"marketing_category": "ANDA",
"nonproprietary_name": "Rivaroxaban",
"start_marketing_date": "20250502",
"active_numerator_strength": "2.5"
}Related drugs
Other records sharing ATC code B01AF01.
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