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United States · US · US:72303-0855_4f1d0d50-8032-d895-e063-6394a90a9bb8
FEBUXOSTAT
Orange BookUNIISPLATC M04AA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHEC Pharm USA Inc.
CountryUS (United States)
ATC codeM04AA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11723030855130 TABLET in 1 BOTTLE (72303-0855-1)
Annotations
UNII (FDA Substance ID)
101V0R1N2E
FEBUXOSTAT
RxCUI 73689
Orange Book
A213069
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": "72303-0855_4f1d0d50-8032-d895-e063-6394a90a9bb8",
"productndc": "72303-0855",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "213069",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "40MG",
"product_no": "001",
"approval_date": "Jun 2, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "80MG",
"product_no": "002",
"approval_date": "Jun 2, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FEBUXOSTAT",
"proprietary_name": "FEBUXOSTAT",
"active_ingred_unit": "mg/1",
"application_number": "ANDA213069",
"marketing_category": "ANDA",
"nonproprietary_name": "febuxostat",
"start_marketing_date": "20260410",
"active_numerator_strength": "40"
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