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United States · US · US:51672-4228_52d1407e-403f-49ef-e063-6294a90ab543
Rivaroxaban
Orange BookUNIISPLATC B01AF01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeB01AF01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11516724228460 TABLET, COATED in 1 BOTTLE (51672-4228-4)
- ndc115167242289180 TABLET, COATED in 1 BOTTLE (51672-4228-9)
Annotations
UNII (FDA Substance ID)
9NDF7JZ4M3
RIVAROXABAN
RxCUI 1114195
Orange Book
A208557
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": {
"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": "51672-4228_52d1407e-403f-49ef-e063-6294a90ab543",
"productndc": "51672-4228",
"dosage_form": "TABLET, COATED",
"orange_book": {
"appl_no": "208557",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "2.5MG",
"product_no": "001",
"approval_date": "Mar 3, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "Oct 7, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "15MG",
"product_no": "003",
"approval_date": "Oct 7, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "004",
"approval_date": "Oct 7, 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": "ANDA208557",
"marketing_category": "ANDA",
"nonproprietary_name": "Rivaroxaban",
"start_marketing_date": "20251015",
"active_numerator_strength": "2.5"
}Related drugs
Other records sharing ATC code B01AF01.
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