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United States · US · US:70518-4326_402f17d7-61cf-529d-e063-6394a90a4bd7
FENOFIBRATE
Orange BookUNIISPLATC C10AB05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerREMEDYREPACK INC.
CountryUS (United States)
ATC codeC10AB05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11705184326090 TABLET in 1 BOTTLE, PLASTIC (70518-4326-0)
Annotations
UNII (FDA Substance ID)
U202363UOS
FENOFIBRATE
RxCUI 221100
Orange Book
A076509
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": "70518-4326_402f17d7-61cf-529d-e063-6394a90a4bd7",
"productndc": "70518-4326",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "076509",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "54MG",
"product_no": "001",
"approval_date": "Mar 26, 2008"
},
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "160MG",
"product_no": "002",
"approval_date": "Mar 26, 2008"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FENOFIBRATE",
"proprietary_name": "FENOFIBRATE",
"active_ingred_unit": "mg/1",
"application_number": "ANDA076509",
"marketing_category": "ANDA",
"nonproprietary_name": "FENOFIBRATE",
"start_marketing_date": "20250410",
"active_numerator_strength": "160"
}Related drugs
Other records sharing ATC code C10AB05.
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