Fenofibrate

Product NDC
50268-311
11-digit product format
502680311
Labeler code
50268
Product ID
50268-311_9c95f7e9-fc00-ca71-e053-2a95a90a44f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fenofibrate
Dosage form
TABLET
Route
ORAL
Labeler
AvPAK
Application
ANDA090856
Marketing category
ANDA
Marketing start
2016-09-19
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
50268-311-122022-02-14C16284748780-1d6a99b39-8698-a426-e053-dadaa90af4c2913945cb-5783-a027-0aa4-45d4a42a84a7
50268-311-122022-01-28C16284748780-1d6a99b39-8698-a426-e053-dadaa90af4c2913945cb-5783-a027-0aa4-45d4a42a84a7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-311-11EA - Each50268-311cbcf09c8-d2d0-463c-9966-b2e0f368727612016-11-08
50268-311-12EA - Each50268-3118cb3a085-399e-4823-aa2a-7c043c28f13412016-11-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-311-125026803111220 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-311-12) > 1 TABLET in 1 BLISTER PACK (50268-311-11) 20 blister pack2016-09-190000-00-00NoNoCurrent