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United States · US · US:72205-416_e8e4275c-6cbe-4976-8cae-f62baf954d27
Rivaroxaban
Orange BookUNIISPLATC B01AF01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNovadoz Pharmaceuticals LLC
CountryUS (United States)
ATC codeB01AF01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11722054160210 BLISTER PACK in 1 CARTON (72205-416-02) / 10 TABLET, FILM COATED in 1 BLISTER PACK
- ndc11722054160330 TABLET, FILM COATED in 1 BOTTLE (72205-416-03)
- ndc11722054160460 TABLET, FILM COATED in 1 BOTTLE (72205-416-04)
- ndc117220541605180 TABLET, FILM COATED in 1 BOTTLE (72205-416-05)
Annotations
UNII (FDA Substance ID)
9NDF7JZ4M3
RIVAROXABAN
RxCUI 1114195
Orange Book
A208546
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": "72205-416_e8e4275c-6cbe-4976-8cae-f62baf954d27",
"productndc": "72205-416",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "208546",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "2.5MG",
"product_no": "001",
"approval_date": "Oct 24, 2025"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "10MG",
"product_no": "002",
"approval_date": "Oct 24, 2025"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "15MG",
"product_no": "003",
"approval_date": "Oct 24, 2025"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "20MG",
"product_no": "004",
"approval_date": "Oct 24, 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": "ANDA208546",
"marketing_category": "ANDA",
"nonproprietary_name": "Rivaroxaban",
"start_marketing_date": "20251024",
"active_numerator_strength": "2.5"
}Related drugs
Other records sharing ATC code B01AF01.
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