🇺🇸
United States · US · US:69097-459_ee5bc824-e200-4a5f-9374-bf71e665aeaa
Fenofibrate
Orange BookUNIISPLATC C10AB05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCipla USA Inc.
CountryUS (United States)
ATC codeC10AB05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11690974590230 TABLET in 1 BOTTLE (69097-459-02)
- ndc11690974590590 TABLET in 1 BOTTLE (69097-459-05)
Annotations
UNII (FDA Substance ID)
U202363UOS
FENOFIBRATE
RxCUI 221100
Orange Book
A208709
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": "69097-459_ee5bc824-e200-4a5f-9374-bf71e665aeaa",
"productndc": "69097-459",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "208709",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "48MG",
"product_no": "001",
"approval_date": "Dec 15, 2016"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "145MG",
"product_no": "002",
"approval_date": "Dec 15, 2016"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FENOFIBRATE",
"proprietary_name": "Fenofibrate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA208709",
"marketing_category": "ANDA",
"nonproprietary_name": "FENOFIBRATE",
"start_marketing_date": "20161215",
"active_numerator_strength": "48"
}Related drugs
Other records sharing ATC code C10AB05.
Access this data programmatically
Query Fenofibrate and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.