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United States · US · US:70748-355_75d51b1e-1d97-40c7-854e-4736e335e048
rivaroxaban granule
Orange BookUNIISPLATC B01AF01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLupin Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeB01AF01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1170748355011 BOTTLE in 1 CARTON (70748-355-01) / 1 FOR SUSPENSION in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
9NDF7JZ4M3
RIVAROXABAN
RxCUI 1114195
Orange Book
A218195
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": "70748-355_75d51b1e-1d97-40c7-854e-4736e335e048",
"productndc": "70748-355",
"dosage_form": "FOR SUSPENSION",
"orange_book": {
"appl_no": "218195",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "1MG/ML",
"product_no": "001",
"approval_date": "Sep 25, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "RIVAROXABAN",
"proprietary_name": "rivaroxaban granule",
"active_ingred_unit": "mg/1",
"application_number": "ANDA218195",
"marketing_category": "ANDA",
"nonproprietary_name": "rivaroxaban granule",
"start_marketing_date": "20250929",
"active_numerator_strength": "155"
}Related drugs
Other records sharing ATC code B01AF01.
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