FENOFIBRATE

Product NDC
50090-7926
11-digit product format
500907926
Labeler code
50090
Product ID
50090-7926_498e266a-53de-4d6d-bb8e-8fa2db52a449
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FENOFIBRATE
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA213864
Marketing category
ANDA
Marketing start
2025-09-29
Substance
FENOFIBRATE
Active strength
160 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
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
50090-7926-0FENOFIBRATE30 in 1 BOTTLETABLET301
50090-7926-1FENOFIBRATE90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7926-0EA - Each50090-7926660044d0-0243-407e-b66f-5f6e1c1be09c12026-04-20
50090-7926-1EA - Each50090-79267e214064-7a5d-4b3e-ac1e-ced3d660b76e12026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349287fenofibrate 160 MG Oral TabletPSNf443dd79-46da-4b02-8188-7417d39cf9751
349287fenofibrate 160 MG Oral TabletSCDf443dd79-46da-4b02-8188-7417d39cf9751

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7926-05009079260030 TABLET in 1 BOTTLE (50090-7926-0) 30 tablet2026-03-05NoNoHistorical
50090-7926-15009079260190 TABLET in 1 BOTTLE (50090-7926-1) 90 tablet2026-03-05NoNoHistorical