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United States · US · US:71335-0891_ee27b981-5895-4414-b4ec-a0663e72fdc5
FENOFIBRATE
Orange BookUNIISPLATC C10AB05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeC10AB05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11713350891130 TABLET in 1 BOTTLE (71335-0891-1)
- ndc11713350891290 TABLET in 1 BOTTLE (71335-0891-2)
- ndc11713350891328 TABLET in 1 BOTTLE (71335-0891-3)
Annotations
UNII (FDA Substance ID)
U202363UOS
FENOFIBRATE
RxCUI 221100
Orange Book
A208709
ABAB
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": "71335-0891_ee27b981-5895-4414-b4ec-a0663e72fdc5",
"productndc": "71335-0891",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "208709",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "48MG",
"product_no": "001",
"approval_date": "Dec 15, 2016"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "145MG",
"product_no": "002",
"approval_date": "Dec 15, 2016"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FENOFIBRATE",
"proprietary_name": "FENOFIBRATE",
"active_ingred_unit": "mg/1",
"application_number": "ANDA208709",
"marketing_category": "ANDA",
"nonproprietary_name": "FENOFIBRATE",
"start_marketing_date": "20161215",
"active_numerator_strength": "48"
}Related drugs
Other records sharing ATC code C10AB05.
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