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United States · US · US:60505-3120_81d94e71-5260-d81d-f3b9-070ec3c0743a
Fenofibrate
Orange BookUNIISPLATC C10AB05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerApotex Corp.
CountryUS (United States)
ATC codeC10AB05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc116050531201100 CAPSULE in 1 BOTTLE (60505-3120-1)
- ndc11605053120330 CAPSULE in 1 BOTTLE (60505-3120-3)
Annotations
UNII (FDA Substance ID)
U202363UOS
FENOFIBRATE
RxCUI 221100
Orange Book
A202252
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": "60505-3120_81d94e71-5260-d81d-f3b9-070ec3c0743a",
"productndc": "60505-3120",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "202252",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "43MG",
"product_no": "001",
"approval_date": "Jul 26, 2013"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "130MG",
"product_no": "002",
"approval_date": "Jul 26, 2013"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FENOFIBRATE",
"proprietary_name": "Fenofibrate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA202252",
"marketing_category": "ANDA",
"nonproprietary_name": "Fenofibrate",
"start_marketing_date": "20130726",
"active_numerator_strength": "43"
}Related drugs
Other records sharing ATC code C10AB05.
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