FDA.reportPublic FDA data

Fenofibrate

Product NDC
46708-351
11-digit product format
467080351
Labeler code
46708
Product ID
46708-351_8250e3fe-6420-401e-af14-45662b8a7b48
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fenofibrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA213252
Marketing category
ANDA
Marketing start
2020-01-23
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
46708-351-302023-02-01C16284748780-1f386c649-cad2-0266-e053-dadaa90a7c1aThese 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
46708-351-712023-02-01C16284748780-1f386c649-cad2-0266-e053-dadaa90a7c1aThese 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
46708-351-902023-02-01C16284748780-1f386c649-cad2-0266-e053-dadaa90a7c1aThese 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
46708-351-302023-01-30C16284748780-1f386c649-cad2-0266-e053-dadaa90a7c1aThese 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
46708-351-712023-01-30C16284748780-1f386c649-cad2-0266-e053-dadaa90a7c1aThese 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
46708-351-902023-01-30C16284748780-1f386c649-cad2-0266-e053-dadaa90a7c1aThese 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
46708-351-30Fenofibrate30 in 1 BOTTLETABLET, FILM COATED302
46708-351-71Fenofibrate500 in 1 BOTTLETABLET, FILM COATED5002
46708-351-90Fenofibrate90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-351FENOFIBRATE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED]2Current NDC, Legacy NDC, 3 package rows20230202_65ca643c-3b31-4e53-bc06-0e11418baf7d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349287fenofibrate 160 MG Oral TabletPSN65ca643c-3b31-4e53-bc06-0e11418baf7d2
351133fenofibrate 54 MG Oral TabletPSN65ca643c-3b31-4e53-bc06-0e11418baf7d2
349287fenofibrate 160 MG Oral TabletSCD65ca643c-3b31-4e53-bc06-0e11418baf7d2
351133fenofibrate 54 MG Oral TabletSCD65ca643c-3b31-4e53-bc06-0e11418baf7d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
46708-351-304670803513030 TABLET, FILM COATED in 1 BOTTLE (46708-351-30) 2020-01-230000-00-00NoNoCurrent
46708-351-7146708035171500 TABLET, FILM COATED in 1 BOTTLE (46708-351-71) 2020-01-230000-00-00NoNoCurrent
46708-351-904670803519090 TABLET, FILM COATED in 1 BOTTLE (46708-351-90) 2020-01-230000-00-00NoNoCurrent