🇺🇸
United States · US · US:85766-058_502f0591-7637-2e7b-e063-6294a90a6e98
Xofluza
Orange BookUNIISPLATC J05AX25
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSportpharm LLC
CountryUS (United States)
ATC codeJ05AX25
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1185766058011 BLISTER PACK in 1 CARTON (85766-058-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
505CXM6OHG
BALOXAVIR MARBOXIL
RxCUI 2099995
Orange Book
N210854
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "505CXM6OHG",
"rxcui": "2099995",
"inchikey": "RZVPBGBYGMDSBG-GGAORHGYSA-N",
"display_name": "BALOXAVIR MARBOXIL",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"b58b2899-4d22-41e1-8f0c-bdead8917694": {
"match": "brand_token",
"title": "XOFLUZA (BALOXAVIR MARBOXIL) TABLET, FILM COATED [SPORTPHARM LLC]",
"spl_version": "2",
"published_date": "2026-04-27"
}
},
"productid": "85766-058_502f0591-7637-2e7b-e063-6294a90a6e98",
"productndc": "85766-058",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "210854",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "001",
"approval_date": "Oct 24, 2018"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "40MG",
"product_no": "002",
"approval_date": "Oct 24, 2018"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "80MG",
"product_no": "003",
"approval_date": "Mar 18, 2021"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BALOXAVIR MARBOXIL",
"proprietary_name": "Xofluza",
"active_ingred_unit": "mg/1",
"application_number": "NDA210854",
"marketing_category": "NDA",
"nonproprietary_name": "BALOXAVIR MARBOXIL",
"start_marketing_date": "20181024",
"active_numerator_strength": "80"
}Related drugs
Other records sharing ATC code J05AX25.
Access this data programmatically
Query Xofluza 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.