FDA.reportPublic FDA data

Fenofibrate

Product NDC
68180-389
11-digit product format
681800389
Labeler code
68180
Product ID
68180-389_e454c5bc-7a0e-4d5e-95fb-ccf812747a3c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fenofibrate
Dosage form
TABLET
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA090856
Marketing category
ANDA
Marketing start
2020-08-01
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, 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
68180-389-02Fenofibrate500 in 1 BOTTLETABLET50022
68180-389-09Fenofibrate90 in 1 BOTTLETABLET9022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-389-02EA - Each68180-38990609456-a22a-4307-acf5-c45c1e63299912021-01-08
68180-389-09EA - Each68180-389fe9c96a2-6b0c-4c78-ba92-d7f42f4f8ae912021-01-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FENOFIBRATEACTIVE INGREDIENTU202363UOSFENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.]4
FENOFIBRATEACTIVE MOIETYU202363UOSFENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKFENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.]4
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.]4
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQUFENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AFENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.]4
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JFENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.]4
SUCROSEINACTIVE INGREDIENTC151H8M554FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.]4
TALCINACTIVE INGREDIENT7SEV7J4R1UFENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-389FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.]19Current NDC, Legacy NDC, 2 package rows20250316_45364845-c3b4-40a1-a677-82202ffaa5ad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
477560fenofibrate 145 MG Oral TabletPSN45364845-c3b4-40a1-a677-82202ffaa5ad22
477562fenofibrate 48 MG Oral TabletPSN45364845-c3b4-40a1-a677-82202ffaa5ad22
477560fenofibrate 145 MG Oral TabletSCD45364845-c3b4-40a1-a677-82202ffaa5ad22
477562fenofibrate 48 MG Oral TabletSCD45364845-c3b4-40a1-a677-82202ffaa5ad22
477560fenofibrate 145 MG Oral TabletPSNd1f64796-6ba0-415c-a6a0-5456b21a7ed67
477562fenofibrate 48 MG Oral TabletPSNd1f64796-6ba0-415c-a6a0-5456b21a7ed67
477560fenofibrate 145 MG Oral TabletSCDd1f64796-6ba0-415c-a6a0-5456b21a7ed67
477562fenofibrate 48 MG Oral TabletSCDd1f64796-6ba0-415c-a6a0-5456b21a7ed67
477560fenofibrate 145 MG Oral TabletPSNd9be3ae3-6da9-47fd-bcfd-e561b9d585ca3
477560fenofibrate 145 MG Oral TabletSCDd9be3ae3-6da9-47fd-bcfd-e561b9d585ca3
477560fenofibrate 145 MG Oral TabletPSN0865c177-b78a-318e-e063-6394a90a318a2
477560fenofibrate 145 MG Oral TabletSCD0865c177-b78a-318e-e063-6394a90a318a2
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 startMarketing endSampleExclude flagStatus
68180-389-0268180038902500 TABLET in 1 BOTTLE (68180-389-02) 500 tablet2020-08-010000-00-00NoNoCurrent
68180-389-096818003890990 TABLET in 1 BOTTLE (68180-389-09) 90 tablet2020-08-010000-00-00NoNoCurrent