FDA.reportPublic FDA data

Fenofibrate

Product NDC
68788-4006
11-digit product format
687884006
Labeler code
68788
Product ID
68788-4006_2e6711e9-782d-46bd-9447-6612fe7d0fe7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fenofibrate
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA090856
Marketing category
ANDA
Marketing start
2025-08-08
Substance
FENOFIBRATE
Active strength
145 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
FENOFIBRATE145 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU202363UOS
Rxcui477560

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
68788-4006-1Fenofibrate100 in 1 BOTTLETABLET1001
68788-4006-3Fenofibrate30 in 1 BOTTLETABLET301
68788-4006-6Fenofibrate60 in 1 BOTTLETABLET601
68788-4006-9Fenofibrate90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-4006-1EA - Each68788-40066325bc89-e827-496b-8859-e8498e2bde7e12025-11-13
68788-4006-3EA - Each68788-4006a72a9252-7aee-458d-91c5-449dbb29e7d212025-11-13
68788-4006-6EA - Each68788-40064df7d422-3ace-4f87-9e13-bd988d263c7812025-11-13
68788-4006-9EA - Each68788-40067a7ffd01-a447-448f-948e-f4569c81722112025-11-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
477560fenofibrate 145 MG Oral TabletPSN2e6711e9-782d-46bd-9447-6612fe7d0fe71
477560fenofibrate 145 MG Oral TabletSCD2e6711e9-782d-46bd-9447-6612fe7d0fe71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-4006-168788400601100 TABLET in 1 BOTTLE (68788-4006-1) 100 tablet2025-08-08NoNoCurrent
68788-4006-36878840060330 TABLET in 1 BOTTLE (68788-4006-3) 30 tablet2025-08-08NoNoCurrent
68788-4006-66878840060660 TABLET in 1 BOTTLE (68788-4006-6) 60 tablet2025-08-08NoNoCurrent
68788-4006-96878840060990 TABLET in 1 BOTTLE (68788-4006-9) 90 tablet2025-08-08NoNoCurrent