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United States · US · US:0904-7539_9eb677e7-08d9-40a3-b983-21fa58b42296
FENOFIBRATE
Orange BookUNIISPLATC C10AB05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMajor Pharmaceuticals
CountryUS (United States)
ATC codeC10AB05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11090475390430 BLISTER PACK in 1 CARTON (0904-7539-04) / 1 TABLET in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
U202363UOS
FENOFIBRATE
RxCUI 221100
Orange Book
A213864
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": "0904-7539_9eb677e7-08d9-40a3-b983-21fa58b42296",
"productndc": "0904-7539",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "213864",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "54MG",
"product_no": "001",
"approval_date": "Jun 12, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "160MG",
"product_no": "002",
"approval_date": "Jun 12, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FENOFIBRATE",
"proprietary_name": "FENOFIBRATE",
"active_ingred_unit": "mg/1",
"application_number": "ANDA213864",
"marketing_category": "ANDA",
"nonproprietary_name": "FENOFIBRATE",
"start_marketing_date": "20250522",
"active_numerator_strength": "160"
}Related drugs
Other records sharing ATC code C10AB05.
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