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United States · US · US:13668-438_6602b2c6-0128-4d70-8581-9abee72f152e
Fenofibrate
Orange BookUNIISPLATC C10AB05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTorrent Pharmaceuticals Limited
CountryUS (United States)
ATC codeC10AB05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc111366843801100 CAPSULE in 1 BOTTLE (13668-438-01)
- ndc111366843805500 CAPSULE in 1 BOTTLE (13668-438-05)
- ndc11136684389090 CAPSULE in 1 BOTTLE (13668-438-90)
Annotations
UNII (FDA Substance ID)
U202363UOS
FENOFIBRATE
RxCUI 221100
Orange Book
A210782
ABABAB
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": "13668-438_6602b2c6-0128-4d70-8581-9abee72f152e",
"productndc": "13668-438",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "210782",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "67MG",
"product_no": "001",
"approval_date": "Jun 26, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "134MG",
"product_no": "002",
"approval_date": "Jun 26, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "200MG",
"product_no": "003",
"approval_date": "Jun 26, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FENOFIBRATE",
"proprietary_name": "Fenofibrate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA210782",
"marketing_category": "ANDA",
"nonproprietary_name": "Fenofibrate",
"start_marketing_date": "20180701",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code C10AB05.
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