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United States · US · US:33342-347_a504c42a-b629-4a21-a716-084962266b48
Fenofibrate
Orange BookUNIISPLATC C10AB05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMacleods Pharmaceuticals Limited
CountryUS (United States)
ATC codeC10AB05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11333423471090 TABLET in 1 CONTAINER (33342-347-10)
- ndc11333423471210 BLISTER PACK in 1 CARTON (33342-347-12) / 10 TABLET in 1 BLISTER PACK
- ndc1133342347479 BLISTER PACK in 1 CARTON (33342-347-47) / 14 TABLET in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
U202363UOS
FENOFIBRATE
RxCUI 221100
Orange Book
A210379
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": "33342-347_a504c42a-b629-4a21-a716-084962266b48",
"productndc": "33342-347",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "210379",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "54MG",
"product_no": "001",
"approval_date": "Jan 21, 2026"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "160MG",
"product_no": "002",
"approval_date": "Jan 21, 2026"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FENOFIBRATE",
"proprietary_name": "Fenofibrate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA210379",
"marketing_category": "ANDA",
"nonproprietary_name": "Fenofibrate",
"start_marketing_date": "20260121",
"active_numerator_strength": "54"
}Related drugs
Other records sharing ATC code C10AB05.
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