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United States · US · US:71335-0741_01c33ccd-f3ff-40c4-901e-fecc9b1c7791
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
- ndc11713350741130 TABLET, FILM COATED in 1 BOTTLE (71335-0741-1)
- ndc11713350741290 TABLET, FILM COATED in 1 BOTTLE (71335-0741-2)
- ndc11713350741360 TABLET, FILM COATED in 1 BOTTLE (71335-0741-3)
- ndc11713350741428 TABLET, FILM COATED in 1 BOTTLE (71335-0741-4)
- ndc117133507415100 TABLET, FILM COATED in 1 BOTTLE (71335-0741-5)
Annotations
UNII (FDA Substance ID)
U202363UOS
FENOFIBRATE
RxCUI 221100
Orange Book
A076433
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": "71335-0741_01c33ccd-f3ff-40c4-901e-fecc9b1c7791",
"productndc": "71335-0741",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "076433",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "54MG",
"product_no": "001",
"approval_date": "May 13, 2005"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "160MG",
"product_no": "002",
"approval_date": "May 13, 2005"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FENOFIBRATE",
"proprietary_name": "Fenofibrate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA076433",
"marketing_category": "ANDA",
"nonproprietary_name": "Fenofibrate",
"start_marketing_date": "20170601",
"active_numerator_strength": "160"
}Related drugs
Other records sharing ATC code C10AB05.
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