🇺🇸
United States · US · US:33342-275_eb38172a-f884-4a94-be6d-73ad338fb29c
Febuxostat
Orange BookUNIISPLATC M04AA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMacleods Pharmaceuticals Limited
CountryUS (United States)
ATC codeM04AA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11333422750730 FILM in 1 BOTTLE (33342-275-07)
- ndc11333422751090 FILM in 1 BOTTLE (33342-275-10)
- ndc113334227515500 FILM in 1 BOTTLE (33342-275-15)
Annotations
UNII (FDA Substance ID)
101V0R1N2E
FEBUXOSTAT
RxCUI 73689
Orange Book
A207293
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": {
"f2c338dc-5bab-49f4-a4ac-d8dea8afeea5": {
"match": "brand_token",
"title": "FEBUXOSTAT TABLET [REMEDYREPACK INC.]",
"spl_version": "1",
"published_date": "2026-04-28"
}
},
"productid": "33342-275_eb38172a-f884-4a94-be6d-73ad338fb29c",
"productndc": "33342-275",
"dosage_form": "FILM",
"orange_book": {
"appl_no": "207293",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "40MG",
"product_no": "001",
"approval_date": "Sep 28, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "80MG",
"product_no": "002",
"approval_date": "Sep 28, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FEBUXOSTAT",
"proprietary_name": "Febuxostat",
"active_ingred_unit": "mg/1",
"application_number": "ANDA207293",
"marketing_category": "ANDA",
"nonproprietary_name": "Febuxostat tablets 80 mg",
"start_marketing_date": "20190404",
"active_numerator_strength": "80"
}Related drugs
Other records sharing ATC code M04AA03.
- NOAdenuricMenarini International O.L. SA
- 🇨🇭Adenuric
- PLAdenuricMenarini International Operations Luxembourg S.A.
- PLAdenuricMenarini International Operations Luxembourg S.A.
- ISAdenuricMenarini International Operations Luxembourg S.A.
- 🇨🇭Adenuric
- ISAdenuricMenarini International Operations Luxembourg S.A.
- NOAdenuricMenarini International O.L. SA
Access this data programmatically
Query Febuxostat 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.