Fenofibrate

Product NDC
72162-2170
11-digit product format
721622170
Labeler code
72162
Product ID
72162-2170_69d90731-598d-4cfa-93f3-b9641d385d9f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FENOFIBRATE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA210670
Marketing category
ANDA
Marketing start
2020-01-31
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

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
72162-2170-9Fenofibrate90 in 1 BOTTLETABLET, FILM COATED90100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2170-9EA - Each72162-217039cabd0a-1be1-4e03-93e9-68f05aa02e7212024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2170FENOFIBRATE TABLET, FILM COATED [BRYANT RANCH PREPACK]100Current NDC, 1 package rows20231212_f3af845c-ce4e-4bf2-82e7-7753c9088645.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349287fenofibrate 160 MG Oral TabletPSNf3af845c-ce4e-4bf2-82e7-7753c9088645100
349287fenofibrate 160 MG Oral TabletSCDf3af845c-ce4e-4bf2-82e7-7753c9088645100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-2170-97216221700990 TABLET, FILM COATED in 1 BOTTLE (72162-2170-9) 2023-12-07NoNoCurrent