🇺🇸
United States · US · US:42385-944_f0e00f9f-65f5-407a-e053-2a95a90a260f
FENOFIBRIC ACID DELAYED-RELEASE
Orange BookUNIISPLATC C10AB
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLaurus Labs Limited
CountryUS (United States)
ATC codeC10AB
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1142385944111000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (42385-944-11)
- ndc11423859443030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (42385-944-30)
- ndc11423859449090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (42385-944-90)
Annotations
UNII (FDA Substance ID)
BGF9MN2HU1
FENOFIBRIC ACID
RxCUI 24852
Orange Book
A211626
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": "42385-944_f0e00f9f-65f5-407a-e053-2a95a90a260f",
"productndc": "42385-944",
"dosage_form": "CAPSULE, DELAYED RELEASE",
"orange_book": {
"appl_no": "211626",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 45MG FENOFIBRIC ACID",
"product_no": "001",
"approval_date": "Jul 18, 2019"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 135MG FENOFIBRIC ACID",
"product_no": "002",
"approval_date": "Jul 18, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FENOFIBRIC ACID",
"proprietary_name": "FENOFIBRIC ACID DELAYED-RELEASE",
"active_ingred_unit": "mg/1",
"application_number": "ANDA211626",
"marketing_category": "ANDA",
"nonproprietary_name": "FENOFIBRIC ACID",
"start_marketing_date": "20200824",
"active_numerator_strength": "45"
}Related drugs
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