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United States · US · US:62559-461_9938193b-bd47-4176-9e2e-840f09112fff
Fenofibrate
Orange BookUNIISPLATC C10AB05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerANI Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeC10AB05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11625594619090 CAPSULE in 1 BOTTLE (62559-461-90)
Annotations
UNII (FDA Substance ID)
U202363UOS
FENOFIBRATE
RxCUI 221100
Orange Book
N021612
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "U202363UOS",
"rxcui": "221100",
"inchikey": "YMTINGFKWWXKFG-UHFFFAOYSA-N",
"display_name": "FENOFIBRATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"3a69e15a-eda6-4a6e-8934-6881e4370521": {
"match": "brand_token",
"title": "FENOFIBRATE CAPSULE [ANI PHARMACEUTICALS, INC.]",
"spl_version": "10",
"published_date": "2026-06-01"
}
},
"productid": "62559-461_9938193b-bd47-4176-9e2e-840f09112fff",
"productndc": "62559-461",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "021612",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "50MG",
"product_no": "001",
"approval_date": "Jan 11, 2006"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "100MG",
"product_no": "002",
"approval_date": "Jan 11, 2006"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "150MG",
"product_no": "003",
"approval_date": "Jan 11, 2006"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FENOFIBRATE",
"proprietary_name": "Fenofibrate",
"active_ingred_unit": "mg/1",
"application_number": "NDA021612",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "fenofibrate",
"start_marketing_date": "20160413",
"active_numerator_strength": "150"
}Related drugs
Other records sharing ATC code C10AB05.
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