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United States · US · US:55488-0542_8b1205ed-1f1c-4e13-8076-aefada9213ad
rivaroxaban
Orange BookUNIISPLATC B01AF01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerChangzhou Pharmaceutical Factory
CountryUS (United States)
ATC codeB01AF01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11554880542130 TABLET, FILM COATED in 1 BOTTLE (55488-0542-1)
Annotations
UNII (FDA Substance ID)
9NDF7JZ4M3
RIVAROXABAN
RxCUI 1114195
Orange Book
A216995
ABABAB
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": "55488-0542_8b1205ed-1f1c-4e13-8076-aefada9213ad",
"productndc": "55488-0542",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "216995",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "May 14, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "15MG",
"product_no": "002",
"approval_date": "May 14, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "003",
"approval_date": "May 14, 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": "ANDA216995",
"marketing_category": "ANDA",
"nonproprietary_name": "rivaroxaban",
"start_marketing_date": "20260201",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code B01AF01.
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