FDA.reportPublic FDA data

Fenofibrate

Product NDC
71335-0741
11-digit product format
713350741
Labeler code
71335
Product ID
71335-0741_01c33ccd-f3ff-40c4-901e-fecc9b1c7791
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fenofibrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076433
Marketing category
ANDA
Marketing start
2017-06-01
Substance
FENOFIBRATE
Active strength
160 mg/1
Pharmacologic classes
Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fenofibrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FENOFIBRATE160 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU202363UOS
Rxcui349287

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
71335-0741-1Fenofibrate30 in 1 BOTTLETABLET, FILM COATED308
71335-0741-2Fenofibrate90 in 1 BOTTLETABLET, FILM COATED908
71335-0741-3Fenofibrate60 in 1 BOTTLETABLET, FILM COATED608
71335-0741-4Fenofibrate28 in 1 BOTTLETABLET, FILM COATED288
71335-0741-5Fenofibrate100 in 1 BOTTLETABLET, FILM COATED1008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0741-1EA - Each71335-0741b0b416ff-ace1-4c9d-b5af-de79d7e182c712022-09-12
71335-0741-2EA - Each71335-074134012615-9329-417d-8562-514c7333ca6f12020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0741FENOFIBRATE TABLET, FILM COATED [BRYANT RANCH PREPACK]7Current NDC, Legacy NDC, 5 package rows20231110_40ca5d88-6403-4c4b-ae7f-ae8cec4d9965.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349287fenofibrate 160 MG Oral TabletPSN40ca5d88-6403-4c4b-ae7f-ae8cec4d99658
349287fenofibrate 160 MG Oral TabletSCD40ca5d88-6403-4c4b-ae7f-ae8cec4d99658

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0741-17133507410130 TABLET, FILM COATED in 1 BOTTLE (71335-0741-1) 2018-03-160000-00-00NoNoCurrent
71335-0741-27133507410290 TABLET, FILM COATED in 1 BOTTLE (71335-0741-2) 2018-03-160000-00-00NoNoCurrent
71335-0741-37133507410360 TABLET, FILM COATED in 1 BOTTLE (71335-0741-3) 2021-12-270000-00-00NoNoCurrent
71335-0741-47133507410428 TABLET, FILM COATED in 1 BOTTLE (71335-0741-4) 2021-12-270000-00-00NoNoCurrent
71335-0741-571335074105100 TABLET, FILM COATED in 1 BOTTLE (71335-0741-5) 2021-12-270000-00-00NoNoCurrent