FENOFIBRATE

Product NDC
50090-6973
11-digit product format
500906973
Labeler code
50090
Product ID
50090-6973_de8ee364-daeb-4826-a135-e06db47424f5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FENOFIBRATE
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA076509
Marketing category
ANDA
Marketing start
2022-06-22
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
50090-6973-0FENOFIBRATE30 in 1 BOTTLETABLET303
50090-6973-1FENOFIBRATE90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6973-0EA - Each50090-6973df3f8496-44ac-4848-9ab4-a93cf85ac4b112024-02-14
50090-6973-1EA - Each50090-6973944fbcaf-9ae5-4ce3-806f-25c1ca6b0d1712024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6973FENOFIBRATE TABLET [A-S MEDICATION SOLUTIONS]3Current NDC, 2 package rows20240102_3f2b3a16-7735-487e-9a2c-e078a18df1bc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349287fenofibrate 160 MG Oral TabletPSN3f2b3a16-7735-487e-9a2c-e078a18df1bc3
349287fenofibrate 160 MG Oral TabletSCD3f2b3a16-7735-487e-9a2c-e078a18df1bc3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6973-05009069730030 TABLET in 1 BOTTLE (50090-6973-0) 30 tablet2023-12-21NoNoCurrent
50090-6973-15009069730190 TABLET in 1 BOTTLE (50090-6973-1) 90 tablet2023-12-21NoNoCurrent