FDA.reportPublic FDA data

FENOFIBRATE

Product NDC
68071-5101
11-digit product format
680715101
Labeler code
68071
Product ID
68071-5101_1b46bfc0-ab43-a6a7-e063-6394a90aef41
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FENOFIBRATE
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA208709
Marketing category
ANDA
Marketing start
2016-12-15
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-5101-92024-06-19C16284748780-1ba0f9c33-48e4-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use FENOFIBRATE TABLETS safely and effectively. See full prescribing information for FENOFIBRATE TABLETS. FENOFIBRATE tablets, for oral use Initial U.S. Approval: 1993
68071-5101-92023-01-30C16284748780-1ba0f9c33-48e4-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use FENOFIBRATE TABLETS safely and effectively. See full prescribing information for FENOFIBRATE TABLETS. FENOFIBRATE tablets, for oral use Initial U.S. Approval: 1993
68071-5101-92021-02-22C16284748780-1ba0f9c33-48e4-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use FENOFIBRATE TABLETS safely and effectively. See full prescribing information for FENOFIBRATE TABLETS. FENOFIBRATE tablets, for oral use Initial U.S. Approval: 1993
68071-5101-92021-01-29C16284748780-1ba0f9c33-48e4-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use FENOFIBRATE TABLETS safely and effectively. See full prescribing information for FENOFIBRATE TABLETS. FENOFIBRATE tablets, for oral use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-5101-9FENOFIBRATE90 in 1 BOTTLETABLET903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-5101FENOFIBRATE TABLET [NUCARE PHARMACEUTICALS,INC.]3Current NDC, Legacy NDC, 1 package rows20240621_968e7f57-1360-ba5a-e053-2995a90a206c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
477560fenofibrate 145 MG Oral TabletPSN968e7f57-1360-ba5a-e053-2995a90a206c3
477560fenofibrate 145 MG Oral TabletSCD968e7f57-1360-ba5a-e053-2995a90a206c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-5101-96807151010990 TABLET in 1 BOTTLE (68071-5101-9) 90 tablet2019-11-040000-00-00NoNoCurrent