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United States · US · US:35561-345_5097ee14-8bcd-10bb-e063-6394a90aa196
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 · 3
- ndc11355613451190 CAPSULE in 1 BOTTLE (35561-345-11)
- ndc113556134512100 CAPSULE in 1 BOTTLE (35561-345-12)
- ndc113556134513500 CAPSULE in 1 BOTTLE (35561-345-13)
Annotations
UNII (FDA Substance ID)
U202363UOS
FENOFIBRATE
RxCUI 221100
Orange Book
A207805
ABABAB
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": "35561-345_5097ee14-8bcd-10bb-e063-6394a90aa196",
"productndc": "35561-345",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "207805",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "67MG",
"product_no": "001",
"approval_date": "Nov 16, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "134MG",
"product_no": "002",
"approval_date": "Nov 16, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "200MG",
"product_no": "003",
"approval_date": "Nov 16, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FENOFIBRATE",
"proprietary_name": "Fenofibrate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA207805",
"marketing_category": "ANDA",
"nonproprietary_name": "FENOFIBRATE",
"start_marketing_date": "20171117",
"active_numerator_strength": "67"
}Related drugs
Other records sharing ATC code C10AB05.
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