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United States · US · US:42385-950_f0dd74ce-5a8e-07b1-e053-2a95a90af387
fenofibrate
Orange BookUNIISPLATC C10AB05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLaurus Labs Limited
CountryUS (United States)
ATC codeC10AB05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1142385950111000 TABLET in 1 BOTTLE (42385-950-11)
- ndc11423859503030 TABLET in 1 BOTTLE (42385-950-30)
- ndc11423859509090 TABLET in 1 BOTTLE (42385-950-90)
Annotations
UNII (FDA Substance ID)
U202363UOS
FENOFIBRATE
RxCUI 221100
Orange Book
A211122
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": "42385-950_f0dd74ce-5a8e-07b1-e053-2a95a90af387",
"productndc": "42385-950",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "211122",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "48MG",
"product_no": "001",
"approval_date": "Mar 18, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "145MG",
"product_no": "002",
"approval_date": "Mar 18, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FENOFIBRATE",
"proprietary_name": "fenofibrate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA211122",
"marketing_category": "ANDA",
"nonproprietary_name": "fenofibrate",
"start_marketing_date": "20200318",
"active_numerator_strength": "48"
}Related drugs
Other records sharing ATC code C10AB05.
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