Fenofibrate

Product NDC
69367-257
11-digit product format
693670257
Labeler code
69367
Product ID
69367-257_f79a6a40-a47b-40d9-8b8f-7508198444f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fenofibrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Westminster Pharmaceuticals, LLC
Application
ANDA207803
Marketing category
ANDA
Marketing start
2020-04-23
Marketing end
0000-00-00
Substance
FENOFIBRATE
Active strength
54 mg/1
Pharmacologic classes
Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
193bb7da-5c03-8f95-9048-23ef403846b0Product name320250616
fa35fb9a-7146-716b-13c8-bc1f60030232Product name920250114
cfc78bfa-7d55-47e5-aeb7-71cd79f5ca07Product name820231212
53d5b6b7-785a-4500-9460-263c7f8424b8Product name520210105
ed9d55d4-85bd-0ee7-5b4a-b705646a3a66Product name920200708
36a239c8-03fb-0083-81af-6c1afb195671Product name120140508
a0296d70-ca85-018c-84e8-cf3f630976b7Product name120140508
f2e3e9c8-a2f9-0cc3-a5a5-6dfd0279372aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69367-257-09Fenofibrate90 in 1 BOTTLETABLET, FILM COATED907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69367-257-09EA - Each69367-257614eead6-fb70-4bac-b260-a60cf51eaa0212021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69367-257FENOFIBRATE TABLET, FILM COATED [WESTMINSTER PHARMACEUTICALS, LLC]5Legacy NDC, 1 package rows20240209_a97ebf51-4f68-4426-9958-5c59f91b1d47.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349287fenofibrate 160 MG Oral TabletPSNa97ebf51-4f68-4426-9958-5c59f91b1d477
351133fenofibrate 54 MG Oral TabletPSNa97ebf51-4f68-4426-9958-5c59f91b1d477
349287fenofibrate 160 MG Oral TabletSCDa97ebf51-4f68-4426-9958-5c59f91b1d477
351133fenofibrate 54 MG Oral TabletSCDa97ebf51-4f68-4426-9958-5c59f91b1d477

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69367-257-096936702570990 TABLET, FILM COATED in 1 BOTTLE (69367-257-09) 2020-04-230000-00-00NoNoCurrent