FIBRICOR

Product NDC
71511-501
11-digit product format
715110501
Labeler code
71511
Product ID
71511-501_f1aa0095-4a2d-42cf-b4f5-b88e0f55a4e4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fenofibric Acid
Dosage form
TABLET
Route
ORAL
Labeler
Athena Bioscience, LLC
Application
NDA022418
Marketing category
NDA
Marketing start
2017-08-05
Marketing end
0000-00-00
Substance
FENOFIBRIC ACID
Active strength
35 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
71511-501-302025-02-17C16284748780-1f386c64a-1121-0266-e053-dadaa90a7c1a454af7e2-8734-4a56-b659-02e83d2024fb
71511-501-302023-01-30C16284748780-1f386c64a-1121-0266-e053-dadaa90a7c1a454af7e2-8734-4a56-b659-02e83d2024fb

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71511-501-30EA - Each71511-5019e025b8b-0729-48fa-b37b-c1ced9178ab012019-08-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71511-501-307151105013030 TABLET in 1 BOTTLE, PLASTIC (71511-501-30) 30 tablet2019-03-150000-00-00NoNoCurrent