🇺🇸
United States · US · US:65597-201_dc54247c-0158-4cae-b692-914717ab3a67
SAVAYSA
Orange BookUNIISPLATC B01AF03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDaiichi Sankyo Inc.
CountryUS (United States)
ATC codeB01AF03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc1165597201077 TABLET, FILM COATED in 1 BOTTLE (65597-201-07)
- ndc11655972011010 TABLET, FILM COATED in 1 BLISTER PACK (65597-201-10)
- ndc11655972013030 TABLET, FILM COATED in 1 BOTTLE (65597-201-30)
- ndc116559720150500 TABLET, FILM COATED in 1 BOTTLE (65597-201-50)
- ndc1165597201707 TABLET, FILM COATED in 1 BLISTER PACK (65597-201-70)
- ndc11655972019090 TABLET, FILM COATED in 1 BOTTLE (65597-201-90)
Annotations
UNII (FDA Substance ID)
32W99UE810
EDOXABAN TOSYLATE
RxCUI 1599564
Orange Book
N206316
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "32W99UE810",
"rxcui": "1599564",
"inchikey": "ZLFZITWZOYXXAW-QXXZOGQOSA-N",
"display_name": "EDOXABAN TOSYLATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"e77d3400-56ad-11e3-949a-0800200c9a66": {
"match": "brand_token",
"title": "SAVAYSA (EDOXABAN TOSYLATE) TABLET, FILM COATED [DAIICHI SANKYO INC.]",
"spl_version": "28",
"published_date": "2025-07-14"
}
},
"productid": "65597-201_dc54247c-0158-4cae-b692-914717ab3a67",
"productndc": "65597-201",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "206316",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 15MG BASE",
"product_no": "001",
"approval_date": "Jan 8, 2015"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 30MG BASE",
"product_no": "002",
"approval_date": "Jan 8, 2015"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 60MG BASE",
"product_no": "003",
"approval_date": "Jan 8, 2015"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "EDOXABAN TOSYLATE",
"proprietary_name": "SAVAYSA",
"active_ingred_unit": "mg/1",
"application_number": "NDA206316",
"marketing_category": "NDA",
"nonproprietary_name": "EDOXABAN TOSYLATE",
"start_marketing_date": "20150112",
"active_numerator_strength": "15"
}Related drugs
Other records sharing ATC code B01AF03.
Access this data programmatically
Query SAVAYSA and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.