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United States · US · US:43598-981_eafdf7d8-5014-31c8-daa1-09fc017f5018
Rivaroxaban
Orange BookUNIISPLATC B01AF01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDr.Reddy's Laboratories, Inc.
CountryUS (United States)
ATC codeB01AF01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc114359898118180 TABLET in 1 BOTTLE (43598-981-18)
- ndc11435989816060 TABLET in 1 BOTTLE (43598-981-60)
- ndc11435989817810 BLISTER PACK in 1 CARTON (43598-981-78) / 10 TABLET in 1 BLISTER PACK (43598-981-79)
Annotations
UNII (FDA Substance ID)
9NDF7JZ4M3
RIVAROXABAN
RxCUI 1114195
Orange Book
A208534
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": "43598-981_eafdf7d8-5014-31c8-daa1-09fc017f5018",
"productndc": "43598-981",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "208534",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "2.5MG",
"product_no": "001",
"approval_date": "May 14, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "May 14, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "15MG",
"product_no": "003",
"approval_date": "May 14, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "004",
"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": "ANDA208534",
"marketing_category": "ANDA",
"nonproprietary_name": "Rivaroxaban",
"start_marketing_date": "20250514",
"active_numerator_strength": "2.5"
}Related drugs
Other records sharing ATC code B01AF01.
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