Fenofibrate

Product NDC
0378-7100
11-digit product format
003787100
Labeler code
0378
Product ID
0378-7100_7a2b1694-b5f5-4e1b-b14e-c7abb1e76545
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fenofibrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA076520
Marketing category
ANDA
Marketing start
2009-12-22
Marketing end
0000-00-00
Substance
FENOFIBRATE
Active strength
54 mg/1
Pharmacologic classes
Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-7100-77EA - Each0378-7100e440cf47-b5e0-4aa8-ad61-f5aee6a119cc12012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-7100-770037871007790 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-7100-77) 2009-12-220000-00-00NoNoCurrent