Fenofibrate

Product NDC
50090-5401
11-digit product format
500905401
Labeler code
50090
Product ID
50090-5401_53636d83-cfa6-465c-8ab5-c4c4c71fa354
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fenofibrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA200884
Marketing category
ANDA
Marketing start
2018-06-01
Marketing end
0000-00-00
Substance
FENOFIBRATE
Active strength
48 mg/1
Pharmacologic classes
Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5401-02023-02-07C16284748780-1f386c649-e183-0266-e053-dadaa90a7c1a5ad228c7-fcc1-4be4-90f1-97dff8756bb4
50090-5401-02023-01-30C16284748780-1f386c649-e183-0266-e053-dadaa90a7c1a5ad228c7-fcc1-4be4-90f1-97dff8756bb4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5401-05009054010090 TABLET, FILM COATED in 1 BOTTLE (50090-5401-0) 2020-12-070000-00-00NoNoCurrent