Fenofibric Acid

Product NDC
50090-4561
11-digit product format
500904561
Labeler code
50090
Product ID
50090-4561_a988ac8b-c9ab-4eb8-91b4-735bed59c6e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fenofibric Acid
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
NDA022224
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2016-09-12
Marketing end
0000-00-00
Substance
FENOFIBRIC ACID
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
50090-4561-0Fenofibric Acid90 in 1 BOTTLECAPSULE, DELAYED RELEASE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4561-0EA - Each50090-4561632c3929-77e2-4678-9a50-f180ebfe73fa12022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4561FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]4Legacy NDC, 1 package rows20210417_e3ad559c-b107-409f-a297-a052765b71ab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828373fenofibric acid 135 MG Delayed Release Oral CapsulePSNe3ad559c-b107-409f-a297-a052765b71ab4
828373fenofibric acid 135 MG Delayed Release Oral CapsuleSCDe3ad559c-b107-409f-a297-a052765b71ab4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4561-05009045610090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-4561-0) 2019-09-260000-00-00NoNoCurrent