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United States · US · US:71335-3086_8da3cdaa-ead4-4a80-8347-df88e83d0f08
Fenofibrate
Orange BookUNIISPLATC C10AB05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeC10AB05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc11713353086130 TABLET, FILM COATED in 1 BOTTLE (71335-3086-1)
- ndc11713353086290 TABLET, FILM COATED in 1 BOTTLE (71335-3086-2)
- ndc11713353086360 TABLET, FILM COATED in 1 BOTTLE (71335-3086-3)
- ndc11713353086428 TABLET, FILM COATED in 1 BOTTLE (71335-3086-4)
- ndc117133530865100 TABLET, FILM COATED in 1 BOTTLE (71335-3086-5)
Annotations
UNII (FDA Substance ID)
U202363UOS
FENOFIBRATE
RxCUI 221100
Orange Book
A216798
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": "71335-3086_8da3cdaa-ead4-4a80-8347-df88e83d0f08",
"productndc": "71335-3086",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "216798",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "54MG",
"product_no": "001",
"approval_date": "Sep 27, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "160MG",
"product_no": "002",
"approval_date": "Sep 27, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FENOFIBRATE",
"proprietary_name": "Fenofibrate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA216798",
"marketing_category": "ANDA",
"nonproprietary_name": "Fenofibrate",
"start_marketing_date": "20220927",
"active_numerator_strength": "160"
}Related drugs
Other records sharing ATC code C10AB05.
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