Fenofibrate

Product NDC
68382-270
11-digit product format
683820270
Labeler code
68382
Product ID
68382-270_ed00bf28-39be-4b5a-a500-33962219771b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fenofibrate
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc
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
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68382-270-162020-02-28C16284748780-19d75b9d0-2425-f424-e053-dadaa90a57ce1c3696b1-23c1-2992-86a0-c0882b81048d
68382-270-162020-01-31C16284748780-19d75b9d0-2425-f424-e053-dadaa90a57ce1c3696b1-23c1-2992-86a0-c0882b81048d

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-270-166838202701690 TABLET in 1 BOTTLE (68382-270-16) 90 tablet2016-02-090000-00-00NoNoCurrent