🇺🇸
United States · US · US:42571-348_38613bf4-bb82-1834-e063-6294a90ab048
Fenofibric acid
Orange BookUNIISPLATC C10AB
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMicro Labs Limited
CountryUS (United States)
ATC codeC10AB
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc114257134805500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (42571-348-05)
- ndc11425713483030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (42571-348-30)
- ndc11425713489090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (42571-348-90)
Annotations
UNII (FDA Substance ID)
BGF9MN2HU1
FENOFIBRIC ACID
RxCUI 24852
Orange Book
A213450
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "BGF9MN2HU1",
"rxcui": "24852",
"inchikey": "MQOBSOSZFYZQOK-UHFFFAOYSA-N",
"display_name": "FENOFIBRIC ACID",
"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": "42571-348_38613bf4-bb82-1834-e063-6294a90ab048",
"productndc": "42571-348",
"dosage_form": "CAPSULE, DELAYED RELEASE",
"orange_book": {
"appl_no": "213450",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 45MG FENOFIBRIC ACID",
"product_no": "001",
"approval_date": "Jun 16, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 135MG FENOFIBRIC ACID",
"product_no": "002",
"approval_date": "Jun 16, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FENOFIBRIC ACID",
"proprietary_name": "Fenofibric acid",
"active_ingred_unit": "mg/1",
"application_number": "ANDA213450",
"marketing_category": "ANDA",
"nonproprietary_name": "Fenofibric acid",
"start_marketing_date": "20200901",
"active_numerator_strength": "135"
}Related drugs
Other records sharing ATC code C10AB.
- GBCholib 145mg/20mg tabletsViatris UK Healthcare Ltd
- GBCholib 145mg/40mg tabletsViatris UK Healthcare Ltd
- 🇺🇸Fenofibric acidMicro Labs Limited
- 🇺🇸Fenofibric AcidAlembic Pharmaceuticals Inc.
- 🇺🇸Fenofibric AcidAmneal Pharmaceuticals of New York LLC
- 🇺🇸Fenofibric AcidAmneal Pharmaceuticals of New York LLC
- 🇺🇸Fenofibric AcidAmneal Pharmaceuticals of New York LLC
- 🇺🇸Fenofibric AcidAlembic Pharmaceuticals Limited
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