FDA.reportPublic FDA data

Fenofibrate

Product NDC
68180-232
11-digit product format
681800232
Labeler code
68180
Product ID
68180-232_a70e38c8-07c1-4df6-8c2b-b5e0df3c304d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fenofibrate
Dosage form
TABLET
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA204019
Marketing category
ANDA
Marketing start
2020-07-01
Substance
FENOFIBRATE
Active strength
160 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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68180-232-02Fenofibrate500 in 1 BOTTLETABLET50019
68180-232-03Fenofibrate1000 in 1 BOTTLETABLET100019
68180-232-09Fenofibrate90 in 1 BOTTLETABLET9019

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FENOFIBRATEACTIVE INGREDIENTU202363UOSFENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.]2
FENOFIBRIC ACIDACTIVE MOIETYBGF9MN2HU1FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKFENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.]2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OFENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.]2
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PFENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.]2
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEFENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JFENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.]2
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIFENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UFENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-232FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.]18Current NDC, Legacy NDC, 3 package rows20250316_4cb6617c-f787-470f-81d8-0aba46df937f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349287fenofibrate 160 MG Oral TabletPSN4cb6617c-f787-470f-81d8-0aba46df937f19
351133fenofibrate 54 MG Oral TabletPSN4cb6617c-f787-470f-81d8-0aba46df937f19
349287fenofibrate 160 MG Oral TabletSCD4cb6617c-f787-470f-81d8-0aba46df937f19
351133fenofibrate 54 MG Oral TabletSCD4cb6617c-f787-470f-81d8-0aba46df937f19
349287fenofibrate 160 MG Oral TabletPSN00c2f942-e839-46fc-948a-f8e2fa79ccd17
349287fenofibrate 160 MG Oral TabletSCD00c2f942-e839-46fc-948a-f8e2fa79ccd17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-232-0268180023202500 TABLET in 1 BOTTLE (68180-232-02) 500 tablet2020-07-010000-00-00NoNoCurrent
68180-232-03681800232031000 TABLET in 1 BOTTLE (68180-232-03) 1000 tablet2020-07-010000-00-00NoNoCurrent
68180-232-096818002320990 TABLET in 1 BOTTLE (68180-232-09) 90 tablet2020-07-010000-00-00NoNoCurrent