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United States · US · US:43547-430_df788edb-0354-46af-ae1f-f718f752f31b
FENOFIBRATE
Orange BookUNIISPLATC C10AB05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSolco Healthcare US, LLC
CountryUS (United States)
ATC codeC10AB05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11435474300990 TABLET in 1 BOTTLE (43547-430-09)
- ndc114354743050500 TABLET in 1 BOTTLE (43547-430-50)
Annotations
UNII (FDA Substance ID)
U202363UOS
FENOFIBRATE
RxCUI 221100
Orange Book
A211080
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": "43547-430_df788edb-0354-46af-ae1f-f718f752f31b",
"productndc": "43547-430",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "211080",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "48MG",
"product_no": "001",
"approval_date": "Aug 28, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "145MG",
"product_no": "002",
"approval_date": "Aug 28, 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": "ANDA211080",
"marketing_category": "ANDA",
"nonproprietary_name": "fenofibrate",
"start_marketing_date": "20190220",
"active_numerator_strength": "48"
}Related drugs
Other records sharing ATC code C10AB05.
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