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United States · US · US:82619-101_40b943ae-a94c-308c-e063-6294a90a6413
FENOFIBRATE
Orange BookUNIISPLATC C10AB05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCreekwood Pharmaceuticals LLC
CountryUS (United States)
ATC codeC10AB05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11826191010190 TABLET in 1 BOTTLE (82619-101-01)
Annotations
UNII (FDA Substance ID)
U202363UOS
FENOFIBRATE
RxCUI 221100
Orange Book
A217732
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": "82619-101_40b943ae-a94c-308c-e063-6294a90a6413",
"productndc": "82619-101",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "217732",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "40MG",
"product_no": "001",
"approval_date": "Sep 7, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "120MG",
"product_no": "002",
"approval_date": "Sep 7, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FENOFIBRATE",
"proprietary_name": "FENOFIBRATE",
"active_ingred_unit": "mg/1",
"application_number": "ANDA217732",
"marketing_category": "ANDA",
"nonproprietary_name": "fenofibrate",
"start_marketing_date": "20230907",
"active_numerator_strength": "40"
}Related drugs
Other records sharing ATC code C10AB05.
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