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United States · US · US:67046-1538_3134b1f0-2cc0-d83e-e063-6394a90a171d
Fenofibrate
Orange BookUNIISPLATC C10AB05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCoupler LLC
CountryUS (United States)
ATC codeC10AB05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11670461538330 CAPSULE in 1 BLISTER PACK (67046-1538-3)
Annotations
UNII (FDA Substance ID)
U202363UOS
FENOFIBRATE
RxCUI 221100
Orange Book
A209504
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": "67046-1538_3134b1f0-2cc0-d83e-e063-6394a90a171d",
"productndc": "67046-1538",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "209504",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "67MG",
"product_no": "001",
"approval_date": "Apr 30, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "134MG",
"product_no": "002",
"approval_date": "Apr 30, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "200MG",
"product_no": "003",
"approval_date": "Apr 30, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FENOFIBRATE",
"proprietary_name": "Fenofibrate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA209504",
"marketing_category": "ANDA",
"nonproprietary_name": "Fenofibrate",
"start_marketing_date": "20250325",
"active_numerator_strength": "67"
}Related drugs
Other records sharing ATC code C10AB05.
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