Fenofibrate

Product NDC
68084-827
11-digit product format
680840827
Labeler code
68084
Product ID
68084-827_ea3f5799-f6b3-6653-e053-2a95a90a4544
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fenofibrate
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA076509
Marketing category
ANDA
Marketing start
2014-09-16
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
68084-827-11EA - Each68084-82790036168-fc76-4322-a91b-dadd6c659d5a12014-12-01
68084-827-21EA - Each68084-8270ada0ca1-8267-4de7-829a-b87c9265de0c12014-12-01
68084-827-25EA - Each68084-827d32e2613-e736-4030-82bf-263672861c8a12016-02-04
68084-827-95EA - Each68084-827d8bc7476-bc90-4bf0-9846-09534421acbf12016-02-04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-827-256808408272530 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-827-25) > 1 TABLET in 1 BLISTER PACK (68084-827-95) 30 blister pack2015-12-080000-00-00NoNoCurrent