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United States · US · US:63304-443_f26726b3-a91e-45bc-a02e-a560d898362a
Fenofibrate
Orange BookUNIISPLATC C10AB05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeC10AB05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc116330444305500 CAPSULE in 1 BOTTLE (63304-443-05)
- ndc11633044433030 CAPSULE in 1 BOTTLE (63304-443-30)
Annotations
UNII (FDA Substance ID)
U202363UOS
FENOFIBRATE
RxCUI 221100
Orange Book
A201748
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": "63304-443_f26726b3-a91e-45bc-a02e-a560d898362a",
"productndc": "63304-443",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "201748",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "43MG",
"product_no": "001",
"approval_date": "Oct 31, 2014"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "130MG",
"product_no": "002",
"approval_date": "Oct 31, 2014"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FENOFIBRATE",
"proprietary_name": "Fenofibrate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA201748",
"marketing_category": "ANDA",
"nonproprietary_name": "Fenofibrate",
"start_marketing_date": "20150302",
"active_numerator_strength": "43"
}Related drugs
Other records sharing ATC code C10AB05.
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