FDA.reportPublic FDA data

Fenofibrate

Product NDC
65862-768
11-digit product format
658620768
Labeler code
65862
Product ID
65862-768_05013562-2f49-4b1f-a8eb-5925f3d3bead
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fenofibrate
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
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
Rxcui477560, 477562

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
65862-768-01Fenofibrate100 in 1 BOTTLETABLET, COATED1009
65862-768-05Fenofibrate500 in 1 BOTTLETABLET, COATED5009
65862-768-10Fenofibrate10 in 1 BLISTER PACKTABLET, COATED109
65862-768-78Fenofibrate10 in 1 CARTONTABLET, COATED109
65862-768-90Fenofibrate90 in 1 BOTTLETABLET, COATED909
65862-768-99Fenofibrate1000 in 1 BOTTLETABLET, COATED10009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-768FENOFIBRATE TABLET, COATED [AUROBINDO PHARMA LIMITED]8Current NDC, Legacy NDC, 6 package rows20250221_84fcea7a-05ed-44c2-98fa-7e87b28d2261.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
477560fenofibrate 145 MG Oral TabletPSN84fcea7a-05ed-44c2-98fa-7e87b28d22619
477562fenofibrate 48 MG Oral TabletPSN84fcea7a-05ed-44c2-98fa-7e87b28d22619
477560fenofibrate 145 MG Oral TabletSCD84fcea7a-05ed-44c2-98fa-7e87b28d22619
477562fenofibrate 48 MG Oral TabletSCD84fcea7a-05ed-44c2-98fa-7e87b28d22619
477562fenofibrate 48 MG Oral TabletPSNd0c7070e-b3bb-4b5b-8a62-4e3136b5accc5
477562fenofibrate 48 MG Oral TabletSCDd0c7070e-b3bb-4b5b-8a62-4e3136b5accc5
477562fenofibrate 48 MG Oral TabletPSNbdc2211e-6d65-1500-e053-2a95a90ab1453
477562fenofibrate 48 MG Oral TabletSCDbdc2211e-6d65-1500-e053-2a95a90ab1453

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-768-0165862076801100 TABLET, COATED in 1 BOTTLE (65862-768-01) 2016-05-050000-00-00NoNoCurrent
65862-768-0565862076805500 TABLET, COATED in 1 BOTTLE (65862-768-05) 2016-05-050000-00-00NoNoCurrent
65862-768-106586207681010 in 1 BLISTER PACKHistorical
65862-768-26658620768262500 TABLET, COATED in 1 BAG (65862-768-26)05-MAY-16Current
65862-768-786586207687810 BLISTER PACK in 1 CARTON (65862-768-78) / 10 TABLET, COATED in 1 BLISTER PACK (65862-768-10) 10 blister pack2016-05-050000-00-00NoNoCurrent
65862-768-906586207689090 TABLET, COATED in 1 BOTTLE (65862-768-90) 2016-05-050000-00-00NoNoCurrent
65862-768-99658620768991000 TABLET, COATED in 1 BOTTLE (65862-768-99) 2016-05-050000-00-00NoNoCurrent