FDA.reportPublic FDA data

FENOFIBRATE

Product NDC
0115-5522
11-digit product format
001155522
Labeler code
0115
Product ID
0115-5522_71bb776c-1208-4049-bba2-0f9eb1ea4efe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FENOFIBRATE
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA076509
Marketing category
ANDA
Marketing start
2010-02-01
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0115-5522-012024-01-01C16284748780-10191ceaa-714d-198a-e063-dbdaa90aec3eThese 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
0115-5522-022024-01-01C16284748780-10191ceaa-714d-198a-e063-dbdaa90aec3eThese 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
0115-5522-032024-01-01C16284748780-10191ceaa-714d-198a-e063-dbdaa90aec3eThese 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
0115-5522-102024-01-01C16284748780-10191ceaa-714d-198a-e063-dbdaa90aec3eThese 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
0115-5522-012023-07-28C16284748780-10191ceaa-714d-198a-e063-dbdaa90aec3eThese 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
0115-5522-022023-07-28C16284748780-10191ceaa-714d-198a-e063-dbdaa90aec3eThese 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
0115-5522-032023-07-28C16284748780-10191ceaa-714d-198a-e063-dbdaa90aec3eThese 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
0115-5522-102023-07-28C16284748780-10191ceaa-714d-198a-e063-dbdaa90aec3eThese 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
0115-5522-01FENOFIBRATE100 in 1 BOTTLETABLET10038
0115-5522-02FENOFIBRATE500 in 1 BOTTLETABLET50038
0115-5522-03FENOFIBRATE1000 in 1 BOTTLETABLET100038
0115-5522-10FENOFIBRATE90 in 1 BOTTLETABLET9038

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0115-5522-02EA - Each0115-5522338d8b15-dad5-4e6d-9ed8-e97d8d691bf912012-07-24
0115-5522-10EA - Each0115-55229dd0777f-bb0e-4ae0-a39a-0f94156b586312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FENOFIBRATEACTIVE INGREDIENTU202363UOSFENOFIBRATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]10
FENOFIBRATEACTIVE MOIETYU202363UOSFENOFIBRATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFENOFIBRATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]10
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FENOFIBRATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]10
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GFENOFIBRATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]10
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8FENOFIBRATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]10
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82FENOFIBRATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]10
HYPROMELLOSE 2910 (50 MPA.S)INACTIVE INGREDIENT1IVH67816NFENOFIBRATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]10
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6FENOFIBRATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]10
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFENOFIBRATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FENOFIBRATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]10
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEFENOFIBRATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]10
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AFENOFIBRATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFENOFIBRATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]10
TRIACETININACTIVE INGREDIENTXHX3C3X673FENOFIBRATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]10
FENOFIBRATEACTIVE INGREDIENTU202363UOSFENOFIBRATE TABLET [PHYSICIANS TOTAL CARE, INC.]2
FENOFIBRATEACTIVE MOIETYU202363UOSFENOFIBRATE TABLET [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFENOFIBRATE TABLET [PHYSICIANS TOTAL CARE, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FENOFIBRATE TABLET [PHYSICIANS TOTAL CARE, INC.]2
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82FENOFIBRATE TABLET [PHYSICIANS TOTAL CARE, INC.]2
HYPROMELLOSE 2910 (50 MPA.S)INACTIVE INGREDIENT1IVH67816NFENOFIBRATE TABLET [PHYSICIANS TOTAL CARE, INC.]2
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6FENOFIBRATE TABLET [PHYSICIANS TOTAL CARE, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFENOFIBRATE TABLET [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FENOFIBRATE TABLET [PHYSICIANS TOTAL CARE, INC.]2
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEFENOFIBRATE TABLET [PHYSICIANS TOTAL CARE, INC.]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AFENOFIBRATE TABLET [PHYSICIANS TOTAL CARE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFENOFIBRATE TABLET [PHYSICIANS TOTAL CARE, INC.]2
TRIACETININACTIVE INGREDIENTXHX3C3X673FENOFIBRATE TABLET [PHYSICIANS TOTAL CARE, INC.]2
FENOFIBRATEACTIVE INGREDIENTU202363UOSFENOFIBRATE TABLET [NORTHWIND PHARMACEUTICALS]1
FENOFIBRATEACTIVE MOIETYU202363UOSFENOFIBRATE TABLET [NORTHWIND PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0115-5522FENOFIBRATE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]38Current NDC, Legacy NDC, 4 package rows20240102_fa08cf6a-d306-4979-9b23-ac7febf4fd12.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349287fenofibrate 160 MG Oral TabletPSNfa08cf6a-d306-4979-9b23-ac7febf4fd1238
351133fenofibrate 54 MG Oral TabletPSNfa08cf6a-d306-4979-9b23-ac7febf4fd1238
349287fenofibrate 160 MG Oral TabletSCDfa08cf6a-d306-4979-9b23-ac7febf4fd1238
351133fenofibrate 54 MG Oral TabletSCDfa08cf6a-d306-4979-9b23-ac7febf4fd1238
349287fenofibrate 160 MG Oral TabletPSN9ef583a4-9242-4758-a585-401a83df9e6f15
349287fenofibrate 160 MG Oral TabletSCD9ef583a4-9242-4758-a585-401a83df9e6f15
349287fenofibrate 160 MG Oral TabletPSN4b4447a1-8136-4258-b2c8-c5f9c1bcec925
349287fenofibrate 160 MG Oral TabletSCD4b4447a1-8136-4258-b2c8-c5f9c1bcec925
349287fenofibrate 160 MG Oral TabletPSN8771de7e-b066-ea00-e053-2a95a90a75123
349287fenofibrate 160 MG Oral TabletSCD8771de7e-b066-ea00-e053-2a95a90a75123
349287fenofibrate 160 MG Oral TabletPSN2e51aa89-684d-451e-b513-12b00bf9aea02
351133fenofibrate 54 MG Oral TabletPSN2e51aa89-684d-451e-b513-12b00bf9aea02
349287fenofibrate 160 MG Oral TabletSCD2e51aa89-684d-451e-b513-12b00bf9aea02
351133fenofibrate 54 MG Oral TabletSCD2e51aa89-684d-451e-b513-12b00bf9aea02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0115-5522-0100115552201100 TABLET in 1 BOTTLE (0115-5522-01) 100 tablet2010-02-010000-00-00NoNoCurrent
0115-5522-0200115552202500 TABLET in 1 BOTTLE (0115-5522-02) 500 tablet2010-02-010000-00-00NoNoCurrent
0115-5522-03001155522031000 TABLET in 1 BOTTLE (0115-5522-03) 1000 tablet2010-02-010000-00-00NoNoCurrent
0115-5522-100011555221090 TABLET in 1 BOTTLE (0115-5522-10) 90 tablet2010-02-010000-00-00NoNoCurrent