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United States · US · US:65862-769_05013562-2f49-4b1f-a8eb-5925f3d3bead
Fenofibrate
Orange BookUNIISPLATC C10AB05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeC10AB05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc116586276901100 TABLET, COATED in 1 BOTTLE (65862-769-01)
- ndc116586276905500 TABLET, COATED in 1 BOTTLE (65862-769-05)
- ndc11658627697810 BLISTER PACK in 1 CARTON (65862-769-78) / 10 TABLET, COATED in 1 BLISTER PACK (65862-769-10)
- ndc11658627699090 TABLET, COATED in 1 BOTTLE (65862-769-90)
- ndc1165862769991000 TABLET, COATED in 1 BOTTLE (65862-769-99)
Annotations
UNII (FDA Substance ID)
U202363UOS
FENOFIBRATE
RxCUI 221100
Orange Book
A205118
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": "65862-769_05013562-2f49-4b1f-a8eb-5925f3d3bead",
"productndc": "65862-769",
"dosage_form": "TABLET, COATED",
"orange_book": {
"appl_no": "205118",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "48MG",
"product_no": "001",
"approval_date": "May 5, 2016"
},
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "145MG",
"product_no": "002",
"approval_date": "May 5, 2016"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FENOFIBRATE",
"proprietary_name": "Fenofibrate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA205118",
"marketing_category": "ANDA",
"nonproprietary_name": "Fenofibrate",
"start_marketing_date": "20160505",
"active_numerator_strength": "145"
}Related drugs
Other records sharing ATC code C10AB05.
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