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United States · US · US:62135-894_459be037-d59a-9ee0-e063-6394a90a3b5e
fenofibrate
Orange BookUNIISPLATC C10AB05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerChartwell RX, LLC.
CountryUS (United States)
ATC codeC10AB05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11621358949090 CAPSULE in 1 BOTTLE (62135-894-90)
Annotations
UNII (FDA Substance ID)
U202363UOS
FENOFIBRATE
RxCUI 221100
Orange Book
A211407
ABABAB
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": "62135-894_459be037-d59a-9ee0-e063-6394a90a3b5e",
"productndc": "62135-894",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "211407",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "67MG",
"product_no": "001",
"approval_date": "Jan 31, 2024"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "134MG",
"product_no": "002",
"approval_date": "Jan 31, 2024"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "200MG",
"product_no": "003",
"approval_date": "Jan 31, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FENOFIBRATE",
"proprietary_name": "fenofibrate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA211407",
"marketing_category": "ANDA",
"nonproprietary_name": "fenofibrate",
"start_marketing_date": "20240131",
"active_numerator_strength": "134"
}Related drugs
Other records sharing ATC code C10AB05.
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