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United States · US · US:72578-136_082ca5b7-ccb9-4096-a363-a188d6f51586
febuxostat
Orange BookUNIISPLATC M04AA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerViona Pharmaceuticals Inc
CountryUS (United States)
ATC codeM04AA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc117257813601100 TABLET in 1 BOTTLE (72578-136-01)
- ndc117257813605500 TABLET in 1 BOTTLE (72578-136-05)
- ndc11725781360630 TABLET in 1 BOTTLE (72578-136-06)
- ndc1172578136101000 TABLET in 1 BOTTLE (72578-136-10)
- ndc11725781361690 TABLET in 1 BOTTLE (72578-136-16)
- ndc11725781367710 BLISTER PACK in 1 CARTON (72578-136-77) / 10 TABLET in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
101V0R1N2E
FEBUXOSTAT
RxCUI 73689
Orange Book
A205443
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": "72578-136_082ca5b7-ccb9-4096-a363-a188d6f51586",
"productndc": "72578-136",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "205443",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "40MG",
"product_no": "001",
"approval_date": "Jan 9, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "80MG",
"product_no": "002",
"approval_date": "Jan 9, 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": "ANDA205443",
"marketing_category": "ANDA",
"nonproprietary_name": "febuxostat",
"start_marketing_date": "20230331",
"active_numerator_strength": "40"
}Related drugs
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