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United States · US · US:50242-860_c2da90f4-a11c-46d2-be18-53d286b084cf
Xofluza
Orange BookUNIISPLATC J05AX25
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGenentech, Inc.
CountryUS (United States)
ATC codeJ05AX25
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1150242860011 BLISTER PACK in 1 CARTON (50242-860-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK
- ndc1150242860861 BLISTER PACK in 1 CARTON (50242-860-86) / 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": "50242-860_c2da90f4-a11c-46d2-be18-53d286b084cf",
"productndc": "50242-860",
"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"strength": "20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",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": "40"
}Related drugs
Other records sharing ATC code J05AX25.
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