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United States · US · US:46708-351_8250e3fe-6420-401e-af14-45662b8a7b48
Fenofibrate
Orange BookUNIISPLATC C10AB05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAlembic Pharmaceuticals Limited
CountryUS (United States)
ATC codeC10AB05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11467083513030 TABLET, FILM COATED in 1 BOTTLE (46708-351-30)
- ndc114670835171500 TABLET, FILM COATED in 1 BOTTLE (46708-351-71)
- ndc11467083519090 TABLET, FILM COATED in 1 BOTTLE (46708-351-90)
Annotations
UNII (FDA Substance ID)
U202363UOS
FENOFIBRATE
RxCUI 221100
Orange Book
A213252
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": "46708-351_8250e3fe-6420-401e-af14-45662b8a7b48",
"productndc": "46708-351",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "213252",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "54MG",
"product_no": "001",
"approval_date": "Jan 17, 2020"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "160MG",
"product_no": "002",
"approval_date": "Jan 17, 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": "ANDA213252",
"marketing_category": "ANDA",
"nonproprietary_name": "Fenofibrate",
"start_marketing_date": "20200123",
"active_numerator_strength": "160"
}Related drugs
Other records sharing ATC code C10AB05.
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