GEMFIBROZIL

Product NDC
61919-968
11-digit product format
619190968
Labeler code
61919
Product ID
61919-968_9c9436ae-7de7-1c16-e053-2a95a90a3238
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GEMFIBROZIL
Dosage form
TABLET
Route
ORAL
Labeler
DirectRX
Application
ANDA077836
Marketing category
ANDA
Marketing start
2015-12-03
Marketing end
0000-00-00
Substance
GEMFIBROZIL
Active strength
600 mg/1
Pharmacologic classes
Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
931dfe50-414f-e1ab-9c88-b15c4ba31929Product name520210615

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-968-602023-01-30C16284748780-1f386c649-aedb-0266-e053-dadaa90a7c1aGEMFIBROZIL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-968-60GEMFIBROZIL60 in 1 BOTTLETABLET602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-968-60EA - Each61919-968c040b79b-cc1b-4cfc-8619-2bb987ef279c12016-02-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-968GEMFIBROZIL TABLET [DIRECTRX]2Legacy NDC, 1 package rows20200131_261817da-b8d6-2b32-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310459gemfibrozil 600 MG Oral TabletPSN261817da-b8d6-2b32-e054-00144ff8d46c2
310459gemfibrozil 600 MG Oral TabletSCD261817da-b8d6-2b32-e054-00144ff8d46c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-968-606191909686060 TABLET in 1 BOTTLE (61919-968-60) 60 tablet2015-12-030000-00-00NoNoCurrent