FDA.reportPublic FDA data

Fenofibrate

Product NDC
63629-7316
11-digit product format
636297316
Labeler code
63629
Product ID
63629-7316_f142a83a-a566-43c3-baa3-d6945f0ce936
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fenofibrate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
NDA021656
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2016-02-09
Marketing end
0000-00-00
Substance
FENOFIBRATE
Active strength
145 mg/1
Pharmacologic classes
Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-7316-12020-10-16C16284748780-19d75b9d0-51e8-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Fenofibrate tablets for oral use safely and effectively. See full prescribing information for Fenofibrate tablets for oral use. Fenofibrate Tablets, for oral use Initial U.S. Approval: 1993
63629-7316-22020-10-16C16284748780-19d75b9d0-51e8-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Fenofibrate tablets for oral use safely and effectively. See full prescribing information for Fenofibrate tablets for oral use. Fenofibrate Tablets, for oral use Initial U.S. Approval: 1993
63629-7316-32020-10-16C16284748780-19d75b9d0-51e8-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Fenofibrate tablets for oral use safely and effectively. See full prescribing information for Fenofibrate tablets for oral use. Fenofibrate Tablets, for oral use Initial U.S. Approval: 1993
63629-7316-12020-01-31C16284748780-19d75b9d0-51e8-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Fenofibrate tablets for oral use safely and effectively. See full prescribing information for Fenofibrate tablets for oral use. Fenofibrate Tablets, for oral use Initial U.S. Approval: 1993
63629-7316-22020-01-31C16284748780-19d75b9d0-51e8-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Fenofibrate tablets for oral use safely and effectively. See full prescribing information for Fenofibrate tablets for oral use. Fenofibrate Tablets, for oral use Initial U.S. Approval: 1993
63629-7316-32020-01-31C16284748780-19d75b9d0-51e8-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Fenofibrate tablets for oral use safely and effectively. See full prescribing information for Fenofibrate tablets for oral use. Fenofibrate Tablets, for oral use Initial U.S. Approval: 1993

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-7316-16362973160130 TABLET in 1 BOTTLE (63629-7316-1) 30 tablet2017-06-210000-00-00NoNoCurrent
63629-7316-26362973160290 TABLET in 1 BOTTLE (63629-7316-2) 90 tablet2017-06-210000-00-00NoNoCurrent
63629-7316-36362973160328 TABLET in 1 BOTTLE (63629-7316-3) 28 tablet2017-06-210000-00-00NoNoCurrent