FDA.reportPublic FDA data

Fenofibrate

Product NDC
60505-3120
11-digit product format
605053120
Labeler code
60505
Product ID
60505-3120_81d94e71-5260-d81d-f3b9-070ec3c0743a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fenofibrate
Dosage form
CAPSULE
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA202252
Marketing category
ANDA
Marketing start
2013-07-26
Substance
FENOFIBRATE
Active strength
43 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
FENOFIBRATE43 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU202363UOS
Rxcui483425, 483427

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
60505-3120-1Fenofibrate100 in 1 BOTTLECAPSULE10014
60505-3120-3Fenofibrate30 in 1 BOTTLECAPSULE3014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-3120-3EA - Each60505-312023a02274-bc8b-498e-b6cf-68dab7a60eb112013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FENOFIBRATEACTIVE INGREDIENTU202363UOSFENOFIBRATE CAPSULE [APOTEX CORP.]2
FENOFIBRATEACTIVE MOIETYU202363UOSFENOFIBRATE CAPSULE [APOTEX CORP.]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MFENOFIBRATE CAPSULE [APOTEX CORP.]2
AMMONIAINACTIVE INGREDIENT5138Q19F1XFENOFIBRATE CAPSULE [APOTEX CORP.]2
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3FENOFIBRATE CAPSULE [APOTEX CORP.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKFENOFIBRATE CAPSULE [APOTEX CORP.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GFENOFIBRATE CAPSULE [APOTEX CORP.]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKFENOFIBRATE CAPSULE [APOTEX CORP.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357FENOFIBRATE CAPSULE [APOTEX CORP.]2
GELATININACTIVE INGREDIENT2G86QN327LFENOFIBRATE CAPSULE [APOTEX CORP.]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302FENOFIBRATE CAPSULE [APOTEX CORP.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3FENOFIBRATE CAPSULE [APOTEX CORP.]2
SHELLACINACTIVE INGREDIENT46N107B71OFENOFIBRATE CAPSULE [APOTEX CORP.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FENOFIBRATE CAPSULE [APOTEX CORP.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JFENOFIBRATE CAPSULE [APOTEX CORP.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFENOFIBRATE CAPSULE [APOTEX CORP.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-3120FENOFIBRATE CAPSULE [APOTEX CORP.]12Current NDC, Legacy NDC, 2 package rows20240927_68024459-987a-9cf4-f539-4959093bc9f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483425fenofibrate 130 MG Oral CapsulePSN68024459-987a-9cf4-f539-4959093bc9f014
483427fenofibrate 43 MG Oral CapsulePSN68024459-987a-9cf4-f539-4959093bc9f014
483425fenofibrate 130 MG Oral CapsuleSCD68024459-987a-9cf4-f539-4959093bc9f014
483427fenofibrate 43 MG Oral CapsuleSCD68024459-987a-9cf4-f539-4959093bc9f014

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-3120-160505312001100 CAPSULE in 1 BOTTLE (60505-3120-1) 100 capsule2013-07-260000-00-00NoNoCurrent
60505-3120-36050531200330 CAPSULE in 1 BOTTLE (60505-3120-3) 30 capsule2013-07-260000-00-00NoNoCurrent