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United States · US · US:46708-190_1d0ffd95-5afe-4f03-8ac9-706187144e98
Febuxostat
Orange BookUNIISPLATC M04AA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAlembic Pharmaceuticals Limited
CountryUS (United States)
ATC codeM04AA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc11467081900880 TABLET, COATED in 1 CARTON (46708-190-08)
- ndc114670819010100 TABLET, COATED in 1 CARTON (46708-190-10)
- ndc11467081903030 TABLET, COATED in 1 BOTTLE (46708-190-30)
- ndc114670819031100 TABLET, COATED in 1 BOTTLE (46708-190-31)
- ndc1146708190911000 TABLET, COATED in 1 BOTTLE (46708-190-91)
Annotations
UNII (FDA Substance ID)
101V0R1N2E
FEBUXOSTAT
RxCUI 73689
Orange Book
A205421
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": "46708-190_1d0ffd95-5afe-4f03-8ac9-706187144e98",
"productndc": "46708-190",
"dosage_form": "TABLET, COATED",
"orange_book": {
"appl_no": "205421",
"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": "ANDA205421",
"marketing_category": "ANDA",
"nonproprietary_name": "febuxostat",
"start_marketing_date": "20190701",
"active_numerator_strength": "40"
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