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United States · US · US:62332-085_855b1ec7-573c-417c-8485-0b36f728feaf
Fenofibrate
Orange BookUNIISPLATC C10AB05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAlembic Pharmaceuticals Inc.
CountryUS (United States)
ATC codeC10AB05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11623320853030 CAPSULE in 1 BOTTLE (62332-085-30)
- ndc116233208531100 CAPSULE in 1 BOTTLE (62332-085-31)
- ndc116233208571500 CAPSULE in 1 BOTTLE (62332-085-71)
Annotations
UNII (FDA Substance ID)
U202363UOS
FENOFIBRATE
RxCUI 221100
Orange Book
A213842
ABABAB
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": "62332-085_855b1ec7-573c-417c-8485-0b36f728feaf",
"productndc": "62332-085",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "213842",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "67MG",
"product_no": "001",
"approval_date": "Oct 19, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "134MG",
"product_no": "002",
"approval_date": "Oct 19, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "200MG",
"product_no": "003",
"approval_date": "Oct 19, 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": "ANDA213842",
"marketing_category": "ANDA",
"nonproprietary_name": "Fenofibrate",
"start_marketing_date": "20201022",
"active_numerator_strength": "134"
}Related drugs
Other records sharing ATC code C10AB05.
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