Fenofibric Acid

Product NDC
53489-678
11-digit product format
534890678
Labeler code
53489
Product ID
53489-678_65f745e9-1116-4c2a-9de8-f64fbf92f641
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fenofibric Acid
Dosage form
TABLET
Route
ORAL
Labeler
Mutual Pharmaceutical Company, Inc.
Application
NDA022418
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2009-08-31
Marketing end
0000-00-00
Substance
FENOFIBRIC ACID
Active strength
105 mg/1
Pharmacologic classes
Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53489-678-07EA - Each53489-678fd1c3154-fce2-4312-a8f4-bc96ee63bec212012-07-24
53489-678-90EA - Each53489-6784d46e716-1e7e-4857-9510-d817f709506212012-07-24