FDA.reportPublic FDA data

Fenofibrate

Product NDC
71335-1701
11-digit product format
713351701
Labeler code
71335
Product ID
71335-1701_c44fa90a-0c1f-4750-bdca-71d4e058e58b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fenofibrate
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA205118
Marketing category
ANDA
Marketing start
2016-05-05
Substance
FENOFIBRATE
Active strength
48 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
FENOFIBRATE48 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU202363UOS
Rxcui477562

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
71335-1701-1Fenofibrate30 in 1 BOTTLETABLET, COATED30105
71335-1701-2Fenofibrate90 in 1 BOTTLETABLET, COATED90105
71335-1701-3Fenofibrate28 in 1 BOTTLETABLET, COATED28105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1701FENOFIBRATE TABLET, COATED [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 3 package rows20250402_ba8e809e-f6b5-4ba8-9108-81cc82b14225.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
477562fenofibrate 48 MG Oral TabletPSNba8e809e-f6b5-4ba8-9108-81cc82b14225105
477562fenofibrate 48 MG Oral TabletSCDba8e809e-f6b5-4ba8-9108-81cc82b14225105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1701-17133517010130 TABLET, COATED in 1 BOTTLE (71335-1701-1) 2021-01-120000-00-00NoNoCurrent
71335-1701-27133517010290 TABLET, COATED in 1 BOTTLE (71335-1701-2) 2020-09-080000-00-00NoNoCurrent
71335-1701-37133517010328 TABLET, COATED in 1 BOTTLE (71335-1701-3) 2021-12-290000-00-00NoNoCurrent