FENOFIBRATE

Product NDC
72162-2469
11-digit product format
721622469
Labeler code
72162
Product ID
72162-2469_b7c0d10c-01b1-4753-9e27-facb93f668e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fenofibrate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA217732
Marketing category
ANDA
Marketing start
2023-09-07
Substance
FENOFIBRATE
Active strength
40 mg/1
Pharmacologic classes
Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
FENOFIBRATE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FENOFIBRATE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU202363UOS
Rxcui749802, 749804

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
72162-2469-9FENOFIBRATE90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2469-9EA - Each72162-246924b8169b-dec6-4510-a314-b6f0d572f7f312025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2469FENOFIBRATE TABLET [BRYANT RANCH PREPACK]2Current NDC, 1 package rows20250501_3389b846-8926-3ad5-e063-6294a90aee39.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749802fenofibrate 120 MG Oral TabletPSN3389b846-8926-3ad5-e063-6294a90aee393
749804fenofibrate 40 MG Oral TabletPSN3389b846-8926-3ad5-e063-6294a90aee393
749802fenofibrate 120 MG Oral TabletSCD3389b846-8926-3ad5-e063-6294a90aee393
749804fenofibrate 40 MG Oral TabletSCD3389b846-8926-3ad5-e063-6294a90aee393

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2469-97216224690990 TABLET in 1 BOTTLE (72162-2469-9) 90 tablet2025-04-14NoNoHistorical