🇺🇸
United States · US · US:62559-305_1ce0749b-5c72-4b51-a0d4-df5afe06d9d6
Lipofen
Orange BookUNIISPLATC C10AB05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerANI Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeC10AB05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11625593059090 CAPSULE in 1 BOTTLE (62559-305-90)
Annotations
UNII (FDA Substance ID)
U202363UOS
FENOFIBRATE
RxCUI 221100
Orange Book
N021612
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": {
"78b789b9-854f-46b9-97f3-a48759a6ff89": {
"match": "brand_token",
"title": "LIPOFEN (FENOFIBRATE) CAPSULE [ANI PHARMACEUTICALS, INC.]",
"spl_version": "3",
"published_date": "2026-06-01"
}
},
"productid": "62559-305_1ce0749b-5c72-4b51-a0d4-df5afe06d9d6",
"productndc": "62559-305",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "021612",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "50MG",
"product_no": "001",
"approval_date": "Jan 11, 2006"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "100MG",
"product_no": "002",
"approval_date": "Jan 11, 2006"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "150MG",
"product_no": "003",
"approval_date": "Jan 11, 2006"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FENOFIBRATE",
"proprietary_name": "Lipofen",
"active_ingred_unit": "mg/1",
"application_number": "NDA021612",
"marketing_category": "NDA",
"nonproprietary_name": "fenofibrate",
"start_marketing_date": "20210924",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code C10AB05.
Access this data programmatically
Query Lipofen and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.