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United States · US · US:42385-935_f0dfffd1-9c2c-0cbd-e053-2a95a90a908c
FENOFIBRATE
Orange BookUNIISPLATC C10AB05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLaurus Labs Limited
CountryUS (United States)
ATC codeC10AB05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc114238593505500 TABLET, FILM COATED in 1 BOTTLE (42385-935-05)
- ndc1142385935111000 TABLET, FILM COATED in 1 BOTTLE (42385-935-11)
- ndc11423859353030 TABLET, FILM COATED in 1 BOTTLE (42385-935-30)
- ndc11423859359090 TABLET, FILM COATED in 1 BOTTLE (42385-935-90)
Annotations
UNII (FDA Substance ID)
U202363UOS
FENOFIBRATE
RxCUI 221100
Orange Book
A210606
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": "42385-935_f0dfffd1-9c2c-0cbd-e053-2a95a90a908c",
"productndc": "42385-935",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "210606",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "54MG",
"product_no": "001",
"approval_date": "Aug 17, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "160MG",
"product_no": "002",
"approval_date": "Aug 17, 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": "ANDA210606",
"marketing_category": "ANDA",
"nonproprietary_name": "FENOFIBRATE",
"start_marketing_date": "20200113",
"active_numerator_strength": "54"
}Related drugs
Other records sharing ATC code C10AB05.
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