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United States · US · US:33342-294_94a44831-98b3-41d4-89da-89a43b25d15f
Fenofibric acid
Orange BookUNIISPLATC C10AB11
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMacleods Pharmaceuticals Limited
CountryUS (United States)
ATC codeC10AB11
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11333422941090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-294-10)
- ndc11333422941210 BLISTER PACK in 1 CARTON (33342-294-12) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
4BMH7IZT98
CHOLINE FENOFIBRATE
RxCUI 1433887
Orange Book
A207796
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "4BMH7IZT98",
"rxcui": "1433887",
"inchikey": "JWAZHODZSADEHB-UHFFFAOYSA-M",
"display_name": "CHOLINE FENOFIBRATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"369b3e55-2c05-d879-fe7e-91296c529ae9": {
"match": "brand_token",
"title": "FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]",
"spl_version": "89",
"published_date": "2025-11-19"
}
},
"productid": "33342-294_94a44831-98b3-41d4-89da-89a43b25d15f",
"productndc": "33342-294",
"dosage_form": "CAPSULE, DELAYED RELEASE",
"orange_book": {
"appl_no": "207796",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 45MG FENOFIBRIC ACID",
"product_no": "001",
"approval_date": "Feb 8, 2024"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 135MG FENOFIBRIC ACID",
"product_no": "002",
"approval_date": "Feb 8, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CHOLINE FENOFIBRATE",
"proprietary_name": "Fenofibric acid",
"active_ingred_unit": "mg/1",
"application_number": "ANDA207796",
"marketing_category": "ANDA",
"nonproprietary_name": "Fenofibric acid",
"start_marketing_date": "20240226",
"active_numerator_strength": "45"
}Related drugs
Other records sharing ATC code C10AB11.
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