Fenofibrate

Product NDC
50090-6227
11-digit product format
500906227
Labeler code
50090
Product ID
50090-6227_f2516626-18d2-47a4-be2a-f009ed9a7e9e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fenofibrate
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA204019
Marketing category
ANDA
Marketing start
2020-07-01
Substance
FENOFIBRATE
Active strength
54 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
FENOFIBRATE54 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU202363UOS
Rxcui351133

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
50090-6227-0Fenofibrate90 in 1 BOTTLETABLET906
50090-6227-1Fenofibrate30 in 1 BOTTLETABLET306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6227-0EA - Each50090-6227314459b1-c4dd-4932-863a-af450816222712022-12-07
50090-6227-1EA - Each50090-6227c73460a3-ba9c-4be9-b38d-6e7384c4b2d912022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6227FENOFIBRATE TABLET [A-S MEDICATION SOLUTIONS]6Current NDC, Legacy NDC, 2 package rows20240501_17edfb43-b708-45cc-9b48-54a4d453adac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351133fenofibrate 54 MG Oral TabletPSN17edfb43-b708-45cc-9b48-54a4d453adac6
351133fenofibrate 54 MG Oral TabletSCD17edfb43-b708-45cc-9b48-54a4d453adac6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-6227-05009062270090 TABLET in 1 BOTTLE (50090-6227-0) 90 tablet2022-11-140000-00-00NoNoCurrent
50090-6227-15009062270130 TABLET in 1 BOTTLE (50090-6227-1) 30 tablet2022-11-140000-00-00NoNoCurrent