Fenofibrate

Product NDC
50090-5158
11-digit product format
500905158
Labeler code
50090
Product ID
50090-5158_7c06c7be-a7ba-49ae-a170-62ba5a92c344
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FENOFIBRATE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA210670
Marketing category
ANDA
Marketing start
2020-01-31
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
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5158-12023-02-06C16284748780-1f386c649-f528-0266-e053-dadaa90a7c1a8c15466a-1c6d-4320-8c4d-be24b517928a
50090-5158-12023-01-30C16284748780-1f386c649-f528-0266-e053-dadaa90a7c1a8c15466a-1c6d-4320-8c4d-be24b517928a

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5158-1EA - Each50090-5158200276e7-a9e8-4589-b8c0-e9692454f3e512021-08-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5158-15009051580190 TABLET, FILM COATED in 1 BOTTLE (50090-5158-1) 2020-09-210000-00-00NoNoCurrent