FDA.reportPublic FDA data

FENOFIBRATE

Product NDC
71335-1756
11-digit product format
713351756
Labeler code
71335
Product ID
71335-1756_e4d10350-019b-430a-a9c7-0719b1bc65b6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FENOFIBRATE
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA213864
Marketing category
ANDA
Marketing start
2020-09-10
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
71335-1756-1FENOFIBRATE30 in 1 BOTTLETABLET30101
71335-1756-2FENOFIBRATE90 in 1 BOTTLETABLET90101
71335-1756-3FENOFIBRATE60 in 1 BOTTLETABLET60101
71335-1756-4FENOFIBRATE28 in 1 BOTTLETABLET28101
71335-1756-5FENOFIBRATE100 in 1 BOTTLETABLET100101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1756FENOFIBRATE TABLET [BRYANT RANCH PREPACK]101Current NDC, Legacy NDC, 5 package rows20230401_d34f9fa3-39ae-4b8e-8f29-0d5c655c50b5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349287fenofibrate 160 MG Oral TabletPSNd34f9fa3-39ae-4b8e-8f29-0d5c655c50b5101
349287fenofibrate 160 MG Oral TabletSCDd34f9fa3-39ae-4b8e-8f29-0d5c655c50b5101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1756-17133517560130 TABLET in 1 BOTTLE (71335-1756-1) 30 tablet2021-12-200000-00-00NoNoCurrent
71335-1756-27133517560290 TABLET in 1 BOTTLE (71335-1756-2) 90 tablet2021-12-200000-00-00NoNoCurrent
71335-1756-37133517560360 TABLET in 1 BOTTLE (71335-1756-3) 60 tablet2021-12-200000-00-00NoNoCurrent
71335-1756-47133517560428 TABLET in 1 BOTTLE (71335-1756-4) 28 tablet2021-12-200000-00-00NoNoCurrent
71335-1756-571335175605100 TABLET in 1 BOTTLE (71335-1756-5) 100 tablet2021-12-200000-00-00NoNoCurrent