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United States · US · US:35561-250_4dd565a9-088a-36f9-e063-6394a90ac5e8
Fenofibrate
Orange BookUNIISPLATC C10AB05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBostal LLC
CountryUS (United States)
ATC codeC10AB05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc113556125003500 TABLET, FILM COATED in 1 BOTTLE (35561-250-03)
- ndc11355612501030 TABLET, FILM COATED in 1 BOTTLE (35561-250-10)
- ndc11355612501190 TABLET, FILM COATED in 1 BOTTLE (35561-250-11)
- ndc113556125013500 TABLET, FILM COATED in 1 BOTTLE (35561-250-13)
Annotations
UNII (FDA Substance ID)
U202363UOS
FENOFIBRATE
RxCUI 221100
Orange Book
A208476
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": "35561-250_4dd565a9-088a-36f9-e063-6394a90ac5e8",
"productndc": "35561-250",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "208476",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "48MG",
"product_no": "001",
"approval_date": "Feb 10, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "145MG",
"product_no": "002",
"approval_date": "Feb 10, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FENOFIBRATE",
"proprietary_name": "Fenofibrate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA208476",
"marketing_category": "ANDA",
"nonproprietary_name": "Fenofibrate",
"start_marketing_date": "20210101",
"active_numerator_strength": "145"
}Related drugs
Other records sharing ATC code C10AB05.
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