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United States · US · US:0378-4391_beac0c72-4b03-4b72-9568-db8a22571fe0
Fenofibrate
Orange BookUNIISPLATC C10AB05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMylan Pharmaceuticals Inc.
CountryUS (United States)
ATC codeC10AB05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11037843917790 TABLET in 1 BOTTLE, PLASTIC (0378-4391-77)
Annotations
UNII (FDA Substance ID)
U202363UOS
FENOFIBRATE
RxCUI 221100
Orange Book
A204475
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": "0378-4391_beac0c72-4b03-4b72-9568-db8a22571fe0",
"productndc": "0378-4391",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "204475",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "40MG",
"product_no": "001",
"approval_date": "Jun 23, 2016"
},
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "120MG",
"product_no": "002",
"approval_date": "Jun 23, 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": "ANDA204475",
"marketing_category": "ANDA",
"nonproprietary_name": "fenofibrate",
"start_marketing_date": "20160623",
"active_numerator_strength": "120"
}Related drugs
Other records sharing ATC code C10AB05.
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