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United States · US · US:50268-313_43bf4291-a298-f2fe-e063-6394a90a8fb3
FENOFIBRATE
Orange BookUNIISPLATC C10AB05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAvPAK
CountryUS (United States)
ATC codeC10AB05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11502683131550 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-313-15) / 1 TABLET in 1 BLISTER PACK (50268-313-11)
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": "50268-313_43bf4291-a298-f2fe-e063-6394a90a8fb3",
"productndc": "50268-313",
"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": "20150813",
"active_numerator_strength": "160"
}Related drugs
Other records sharing ATC code C10AB05.
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