Fenofibrate

Product NDC
43353-898
11-digit product format
433530898
Labeler code
43353
Product ID
43353-898_cd1cd9aa-0533-401b-b257-7f3a814c7ff7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fenofibrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA076520
Marketing category
ANDA
Marketing start
2009-12-22
Marketing end
0000-00-00
Substance
FENOFIBRATE
Active strength
160 mg/1
Pharmacologic classes
Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-898-19EA - Each43353-898e6105e7e-8e46-4d1a-b56c-0d069cac440012018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-898FENOFIBRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC20171219_2e6e800b-23a6-4032-88c3-d29beb2d35fc.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43353-898-19433530898193060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-898-19) 2014-03-060000-00-00NoNoCurrent