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United States · US · US:67877-882_d111f8d6-a073-4a43-bf16-bc1bacba9898
Rivaroxaban
Orange BookUNIISPLATC B01AF01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAscend Laboratories, LLC
CountryUS (United States)
ATC codeB01AF01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1167877882711 BOTTLE in 1 CARTON (67877-882-71) / 1 GRANULE, FOR SUSPENSION in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
9NDF7JZ4M3
RIVAROXABAN
RxCUI 1114195
Orange Book
A218502
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": "67877-882_d111f8d6-a073-4a43-bf16-bc1bacba9898",
"productndc": "67877-882",
"dosage_form": "GRANULE, FOR SUSPENSION",
"orange_book": {
"appl_no": "218502",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "1MG/ML",
"product_no": "001",
"approval_date": "Jun 26, 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": "ANDA218502",
"marketing_category": "ANDA",
"nonproprietary_name": "Rivaroxaban",
"start_marketing_date": "20250707",
"active_numerator_strength": "155"
}Related drugs
Other records sharing ATC code B01AF01.
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