Fenofibrate

Product NDC
50090-2546
11-digit product format
500902546
Labeler code
50090
Product ID
50090-2546_7e5a74c2-b323-4764-94f0-452f2c37d15c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fenofibrate
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA204019
Marketing category
ANDA
Marketing start
2015-11-23
Marketing end
0000-00-00
Substance
FENOFIBRATE
Active strength
160 mg/1
Pharmacologic classes
Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
53d5b6b7-785a-4500-9460-263c7f8424b8Product name520210105
ed9d55d4-85bd-0ee7-5b4a-b705646a3a66Product name920200708
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
36a239c8-03fb-0083-81af-6c1afb195671Product name120140508
a0296d70-ca85-018c-84e8-cf3f630976b7Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
f2e3e9c8-a2f9-0cc3-a5a5-6dfd0279372aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2546-0Fenofibrate30 in 1 BOTTLETABLET3010
50090-2546-1Fenofibrate90 in 1 BOTTLETABLET9010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2546-0EA - Each50090-25466ebad9f5-69c1-401d-9a0f-961f35967a7512019-03-12
50090-2546-1EA - Each50090-2546ba0f57f6-1d74-4e47-a845-28ce732b3c7112019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2546FENOFIBRATE TABLET [A-S MEDICATION SOLUTIONS]10Legacy NDC, 2 package rows20210227_b568b38f-06a7-48cd-9b3a-b22182227e15.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349287fenofibrate 160 MG Oral TabletPSNb568b38f-06a7-48cd-9b3a-b22182227e1510
349287fenofibrate 160 MG Oral TabletSCDb568b38f-06a7-48cd-9b3a-b22182227e1510

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-2546-05009025460030 TABLET in 1 BOTTLE (50090-2546-0) 30 tablet2016-10-200000-00-00NoNoCurrent
50090-2546-15009025460190 TABLET in 1 BOTTLE (50090-2546-1) 90 tablet2016-11-110000-00-00NoNoCurrent