🇺🇸
United States · US · US:70771-1553_2a9fa82f-de69-4251-8560-5a59d41356b7
febuxostat
Orange BookUNIISPLATC M04AA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC codeM04AA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc1170771155301000 TABLET in 1 BOTTLE (70771-1553-0)
- ndc117077115531100 TABLET in 1 BOTTLE (70771-1553-1)
- ndc11707711553330 TABLET in 1 BOTTLE (70771-1553-3)
- ndc11707711553410 BLISTER PACK in 1 CARTON (70771-1553-4) / 10 TABLET in 1 BLISTER PACK
- ndc117077115535500 TABLET in 1 BOTTLE (70771-1553-5)
- ndc11707711553990 TABLET in 1 BOTTLE (70771-1553-9)
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": "70771-1553_2a9fa82f-de69-4251-8560-5a59d41356b7",
"productndc": "70771-1553",
"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": "80"
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