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United States · US · US:59651-113_b76fce08-5430-4285-8a39-b689c97afe29
Febuxostat
Orange BookUNIISPLATC M04AA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeM04AA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc115965111305500 TABLET in 1 BOTTLE (59651-113-05)
- ndc11596511133030 TABLET in 1 BOTTLE (59651-113-30)
- ndc11596511139090 TABLET in 1 BOTTLE (59651-113-90)
Annotations
UNII (FDA Substance ID)
101V0R1N2E
FEBUXOSTAT
RxCUI 73689
Orange Book
A210741
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": "59651-113_b76fce08-5430-4285-8a39-b689c97afe29",
"productndc": "59651-113",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "210741",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "40MG",
"product_no": "001",
"approval_date": "Oct 25, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "80MG",
"product_no": "002",
"approval_date": "Oct 25, 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": "ANDA210741",
"marketing_category": "ANDA",
"nonproprietary_name": "Febuxostat",
"start_marketing_date": "20231025",
"active_numerator_strength": "40"
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