🇺🇸
United States · US · US:55111-395_e12ef2fc-f146-a40f-d71c-96a144518d82
Fenofibrate
Orange BookUNIISPLATC C10AB05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDr. Reddy's Laboratories Limited
CountryUS (United States)
ATC codeC10AB05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc115511139501100 CAPSULE in 1 BOTTLE (55111-395-01)
- ndc11551113953030 CAPSULE in 1 BOTTLE (55111-395-30)
- ndc11551113959090 CAPSULE in 1 BOTTLE (55111-395-90)
Annotations
UNII (FDA Substance ID)
U202363UOS
FENOFIBRATE
RxCUI 221100
Orange Book
A090859
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": "55111-395_e12ef2fc-f146-a40f-d71c-96a144518d82",
"productndc": "55111-395",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "090859",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "43MG",
"product_no": "001",
"approval_date": "Mar 1, 2012"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "130MG",
"product_no": "002",
"approval_date": "Mar 1, 2012"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FENOFIBRATE",
"proprietary_name": "Fenofibrate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA090859",
"marketing_category": "ANDA",
"nonproprietary_name": "Fenofibrate",
"start_marketing_date": "20140407",
"active_numerator_strength": "130"
}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.