Fenofibric Acid

Product NDC
72834-105
11-digit product format
728340105
Labeler code
72834
Product ID
72834-105_9793c4bf-c687-4a0a-b356-6f04d521585a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fenofibric Acid
Dosage form
TABLET
Route
ORAL
Labeler
Sarras Health, LLC
Application
NDA022418
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2019-06-27
Marketing end
0000-00-00
Substance
FENOFIBRIC ACID
Active strength
105 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

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72834-105-15Fenofibric Acid15 in 1 BOTTLE, PLASTICTABLET155

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72834-105-15EA - Each72834-105706e4941-c5e7-4791-afc4-a9577a30de0612019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72834-105FENOFIBRIC ACID TABLET [SARRAS HEALTH, LLC]5Legacy NDC, 1 package rows20220101_09310de5-1eaa-44ba-8d9b-2abc1ad1cc33.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860880fenofibric acid 105 MG Oral TabletPSN09310de5-1eaa-44ba-8d9b-2abc1ad1cc335
860886fenofibric acid 35 MG Oral TabletPSN09310de5-1eaa-44ba-8d9b-2abc1ad1cc335
860880fenofibric acid 105 MG Oral TabletSCD09310de5-1eaa-44ba-8d9b-2abc1ad1cc335
860886fenofibric acid 35 MG Oral TabletSCD09310de5-1eaa-44ba-8d9b-2abc1ad1cc335

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72834-105-157283401051515 TABLET in 1 BOTTLE, PLASTIC (72834-105-15) 15 tablet2019-06-270000-00-00NoNoCurrent