fenofibrate

Product NDC
68071-1712
11-digit product format
680711712
Labeler code
68071
Product ID
68071-1712_2d82d34c-f041-3bca-e063-6394a90ad6d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fenofibrate
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA211122
Marketing category
ANDA
Marketing start
2022-07-18
Substance
FENOFIBRATE
Active strength
145 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
68071-1712-96807117120990 TABLET in 1 BOTTLE (68071-1712-9) 90 tablet2023-03-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
fenofibrateNuCare Pharmaceuticals,Inc.2025-02-06HUMAN PRESCRIPTION DRUG LABEL2