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United States · US · US:64764-918_16c36a5a-2f72-4df7-aa6f-1ca27a39404f
ULORIC
Orange BookUNIISPLATC M04AA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTakeda Pharmaceuticals America, Inc.
CountryUS (United States)
ATC codeM04AA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11647649181110 BLISTER PACK in 1 CARTON (64764-918-11) / 10 TABLET in 1 BLISTER PACK
- ndc116476491818500 TABLET in 1 BOTTLE (64764-918-18)
- ndc11647649183030 TABLET in 1 BOTTLE (64764-918-30)
- ndc11647649189090 TABLET in 1 BOTTLE (64764-918-90)
Annotations
UNII (FDA Substance ID)
101V0R1N2E
FEBUXOSTAT
RxCUI 73689
Orange Book
N021856
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "101V0R1N2E",
"rxcui": "73689",
"inchikey": "BQSJTQLCZDPROO-UHFFFAOYSA-N",
"display_name": "FEBUXOSTAT",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"54de10ef-fe5f-4930-b91d-6bbb04c664bd": {
"match": "brand_token",
"title": "ULORIC (FEBUXOSTAT) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.]",
"spl_version": "17",
"published_date": "2025-12-25"
}
},
"productid": "64764-918_16c36a5a-2f72-4df7-aa6f-1ca27a39404f",
"productndc": "64764-918",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "021856",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "40MG",
"product_no": "001",
"approval_date": "Feb 13, 2009"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "80MG",
"product_no": "002",
"approval_date": "Feb 13, 2009"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FEBUXOSTAT",
"proprietary_name": "ULORIC",
"active_ingred_unit": "mg/1",
"application_number": "NDA021856",
"marketing_category": "NDA",
"nonproprietary_name": "febuxostat",
"start_marketing_date": "20090213",
"active_numerator_strength": "40"
}Related drugs
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