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United States · US · US:68788-8106_5ceb6b11-4988-4426-9299-c8a2a98fd175
Fenofibrate
Orange BookUNIISPLATC C10AB05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPreferred Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeC10AB05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc116878881061100 TABLET, FILM COATED in 1 BOTTLE (68788-8106-1)
- ndc11687888106330 TABLET, FILM COATED in 1 BOTTLE (68788-8106-3)
- ndc11687888106660 TABLET, FILM COATED in 1 BOTTLE (68788-8106-6)
- ndc11687888106990 TABLET, FILM COATED in 1 BOTTLE (68788-8106-9)
Annotations
UNII (FDA Substance ID)
U202363UOS
FENOFIBRATE
RxCUI 221100
Orange Book
A204598
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": "68788-8106_5ceb6b11-4988-4426-9299-c8a2a98fd175",
"productndc": "68788-8106",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "204598",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "48MG",
"product_no": "001",
"approval_date": "Jul 12, 2016"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "145MG",
"product_no": "002",
"approval_date": "Jul 12, 2016"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FENOFIBRATE",
"proprietary_name": "Fenofibrate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA204598",
"marketing_category": "ANDA",
"nonproprietary_name": "Fenofibrate",
"start_marketing_date": "20211103",
"active_numerator_strength": "145"
}Related drugs
Other records sharing ATC code C10AB05.
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