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United States · US · US:69097-895_06d917b6-6950-4b49-b830-a1fa0b8ac0b1
Fenofibrate
Orange BookUNIISPLATC C10AB05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCipla USA Inc.,
CountryUS (United States)
ATC codeC10AB05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11690978950230 CAPSULE in 1 BOTTLE, PLASTIC (69097-895-02)
- ndc116909789507100 CAPSULE in 1 BOTTLE, PLASTIC (69097-895-07)
- ndc116909789512500 CAPSULE in 1 BOTTLE, PLASTIC (69097-895-12)
Annotations
UNII (FDA Substance ID)
U202363UOS
FENOFIBRATE
RxCUI 221100
Orange Book
A207378
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": "69097-895_06d917b6-6950-4b49-b830-a1fa0b8ac0b1",
"productndc": "69097-895",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "207378",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "67MG",
"product_no": "001",
"approval_date": "Mar 28, 2017"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "134MG",
"product_no": "002",
"approval_date": "Mar 28, 2017"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "200MG",
"product_no": "003",
"approval_date": "Mar 28, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FENOFIBRATE",
"proprietary_name": "Fenofibrate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA207378",
"marketing_category": "ANDA",
"nonproprietary_name": "fenofibrate",
"start_marketing_date": "20170330",
"active_numerator_strength": "134"
}Related drugs
Other records sharing ATC code C10AB05.
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