FDA.reportPublic FDA data

Fenofibrate

Product NDC
35561-344
11-digit product format
355610344
Labeler code
35561
Product ID
35561-344_49fce536-9885-9845-e063-6394a90af375
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fenofibrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bostal LLC
Application
ANDA207803
Marketing category
ANDA
Marketing start
2019-06-30
Substance
FENOFIBRATE
Active strength
160 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
FENOFIBRATE160 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU202363UOS
Rxcui349287, 351133

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
35561-344-112024-11-25C16284748780-1ba0f9c33-2189-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
35561-344-132024-11-25C16284748780-1ba0f9c33-2189-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
35561-344-112021-01-29C16284748780-1ba0f9c33-2189-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
35561-344-132021-01-29C16284748780-1ba0f9c33-2189-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
35561-344-00Fenofibrate21631 in 1 BOXTABLET, FILM COATED216318
35561-344-11Fenofibrate90 in 1 BOTTLETABLET, FILM COATED908
35561-344-13Fenofibrate500 in 1 BOTTLETABLET, FILM COATED5008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
35561-344-11EA - Each35561-3447427a92c-72cb-4266-a6ea-37beef67f9a312020-01-03
35561-344-13EA - Each35561-344d7a53449-ad59-4715-967a-5d84cb07820a12020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35561-344FENOFIBRATE TABLET, FILM COATED [AUSTARPHARMA LLC]7Current NDC, Legacy NDC, 3 package rows20250402_edace25a-3296-9ca7-dcb8-d0698f65840d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349287fenofibrate 160 MG Oral TabletPSNedace25a-3296-9ca7-dcb8-d0698f65840d8
351133fenofibrate 54 MG Oral TabletPSNedace25a-3296-9ca7-dcb8-d0698f65840d8
349287fenofibrate 160 MG Oral TabletSCDedace25a-3296-9ca7-dcb8-d0698f65840d8
351133fenofibrate 54 MG Oral TabletSCDedace25a-3296-9ca7-dcb8-d0698f65840d8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
35561-344-003556103440021631 TABLET, FILM COATED in 1 BOX (35561-344-00) 2019-06-30NoNoHistorical
35561-344-113556103441190 TABLET, FILM COATED in 1 BOTTLE (35561-344-11) 2019-06-30NoNoHistorical
35561-344-1335561034413500 TABLET, FILM COATED in 1 BOTTLE (35561-344-13) 2019-06-30NoNoHistorical