FDA.reportPublic FDA data

fenofibrate

Product NDC
50090-5244
11-digit product format
500905244
Labeler code
50090
Product ID
50090-5244_58b56882-1789-492c-a872-191e17ae12a3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fenofibrate
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA210138
Marketing category
ANDA
Marketing start
2018-07-20
Substance
FENOFIBRATE
Active strength
54 mg/1
Pharmacologic classes
Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
fenofibrate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FENOFIBRATE54 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU202363UOS
Rxcui351133

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
50090-5244-02023-02-07C16284748780-1f386c64a-20d2-0266-e053-dadaa90a7c1aThese 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
50090-5244-02023-02-07C16284748780-1f386c64a-20d2-0266-e053-dadaa90a7c1aThese 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
50090-5244-12023-02-07C16284748780-1f386c64a-20d2-0266-e053-dadaa90a7c1aThese 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
50090-5244-12023-02-07C16284748780-1f386c64a-20d2-0266-e053-dadaa90a7c1aThese 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
50090-5244-02023-01-30C16284748780-1f386c64a-20d2-0266-e053-dadaa90a7c1aThese 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
50090-5244-02023-01-30C16284748780-1f386c64a-20d2-0266-e053-dadaa90a7c1aThese 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
50090-5244-12023-01-30C16284748780-1f386c64a-20d2-0266-e053-dadaa90a7c1aThese 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
50090-5244-12023-01-30C16284748780-1f386c64a-20d2-0266-e053-dadaa90a7c1aThese 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
50090-5244-0fenofibrate90 in 1 BOTTLETABLET909
50090-5244-1fenofibrate30 in 1 BOTTLETABLET309

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5244-0EA - Each50090-5244010737fc-39bd-458f-93cb-666136b9cc4912024-06-10
50090-5244-1EA - Each50090-52441d7218f4-b2d2-4016-bbde-29bf391d547012024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5244FENOFIBRATE TABLET [A-S MEDICATION SOLUTIONS]7Current NDC, Legacy NDC, 2 package rows20240501_58f0d475-24dc-4f93-aa40-3882b724b70f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351133fenofibrate 54 MG Oral TabletPSN58f0d475-24dc-4f93-aa40-3882b724b70f9
351133fenofibrate 54 MG Oral TabletSCD58f0d475-24dc-4f93-aa40-3882b724b70f9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5244-05009052440090 TABLET in 1 BOTTLE (50090-5244-0) 90 tablet2020-10-120000-00-00NoNoCurrent
50090-5244-15009052440130 TABLET in 1 BOTTLE (50090-5244-1) 30 tablet2020-10-120000-00-00NoNoCurrent