Fenofibric acid

Product NDC
50090-4373
11-digit product format
500904373
Labeler code
50090
Product ID
50090-4373_97ef52b3-93c7-4572-a21d-ccc1540eb56d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fenofibric acid
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA200750
Marketing category
ANDA
Marketing start
2013-12-04
Marketing end
0000-00-00
Substance
CHOLINE FENOFIBRATE
Active strength
135 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
53d5b6b7-785a-4500-9460-263c7f8424b8Product name520210105
ed9d55d4-85bd-0ee7-5b4a-b705646a3a66Product name920200708

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4373-0Fenofibric acid90 in 1 BOTTLECAPSULE, DELAYED RELEASE904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4373FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]4Legacy NDC, 1 package rows20210418_dbae9f9a-763a-4106-94fb-a7fccbb86a4b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828373fenofibric acid 135 MG Delayed Release Oral CapsulePSNdbae9f9a-763a-4106-94fb-a7fccbb86a4b4
828373fenofibric acid 135 MG Delayed Release Oral CapsuleSCDdbae9f9a-763a-4106-94fb-a7fccbb86a4b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4373-05009043730090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-4373-0) 2019-06-200000-00-00NoNoCurrent