Fenofibrate

Product NDC
67046-1538
11-digit product format
670461538
Labeler code
67046
Product ID
67046-1538_3134b1f0-2cc0-d83e-e063-6394a90a171d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fenofibrate
Dosage form
CAPSULE
Route
ORAL
Labeler
Coupler LLC
Application
ANDA209504
Marketing category
ANDA
Marketing start
2025-03-25
Substance
FENOFIBRATE
Active strength
67 mg/1
Pharmacologic classes
Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
U202363UOSFENOFIBRATE49562-28-9FENOFIBRATE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67046-1538-36704615380330 CAPSULE in 1 BLISTER PACK (67046-1538-3) 30 capsule2025-03-25NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Fenofibrate Capsules USPCoupler LLC2025-03-25HUMAN PRESCRIPTION DRUG LABEL1