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United States · US · US:47335-721_53dfe063-e9bf-4069-b4cc-5a83a27d18ec
Febuxostat
Orange BookUNIISPLATC M04AA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeM04AA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc114733572113500 TABLET, FILM COATED in 1 BOTTLE (47335-721-13)
- ndc11473357218190 TABLET, FILM COATED in 1 BOTTLE (47335-721-81)
- ndc11473357218330 TABLET, FILM COATED in 1 BOTTLE (47335-721-83)
Annotations
UNII (FDA Substance ID)
101V0R1N2E
FEBUXOSTAT
RxCUI 73689
Orange Book
A205467
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": "47335-721_53dfe063-e9bf-4069-b4cc-5a83a27d18ec",
"productndc": "47335-721",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "205467",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "40MG",
"product_no": "001",
"approval_date": "Jul 1, 2019"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "80MG",
"product_no": "002",
"approval_date": "Jul 1, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FEBUXOSTAT",
"proprietary_name": "Febuxostat",
"active_ingred_unit": "mg/1",
"application_number": "ANDA205467",
"marketing_category": "ANDA",
"nonproprietary_name": "Febuxostat",
"start_marketing_date": "20190705",
"active_numerator_strength": "40"
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