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United States · US · US:68180-128_574221bf-1643-4dd4-8ac6-29f387ce5eaf
Fenofibric acid
Orange BookUNIISPLATC C10AB11
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLupin Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeC10AB11
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 0
No packs registered.
Annotations
UNII (FDA Substance ID)
4BMH7IZT98
CHOLINE FENOFIBRATE
RxCUI 1433887
Orange Book
A200750
ABAB
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": "68180-128_574221bf-1643-4dd4-8ac6-29f387ce5eaf",
"productndc": "68180-128",
"dosage_form": "CAPSULE, DELAYED RELEASE",
"orange_book": {
"appl_no": "200750",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 45MG FENOFIBRIC ACID",
"product_no": "001",
"approval_date": "Dec 4, 2013"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 135MG FENOFIBRIC ACID",
"product_no": "002",
"approval_date": "Dec 4, 2013"
}
],
"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": "ANDA200750",
"marketing_category": "ANDA",
"nonproprietary_name": "Fenofibric acid",
"start_marketing_date": "20131204",
"active_numerator_strength": "45"
}Related drugs
Other records sharing ATC code C10AB11.
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