Gemfibrozil

Product NDC
67046-231
11-digit product format
670460231
Labeler code
67046
Product ID
67046-231_e2ec8e47-8f4e-44cc-82ff-1d4511d3fadd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gemfibrozil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA077836
Marketing category
ANDA
Marketing start
2010-11-09
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
E
Listing certified through
2017-12-31
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
67046-231-302019-10-29C16284748780-1960f7f55-d760-8e05-e053-dbdaa90a074aGEMFIBROZIL TABLETS USP, 600 mg Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-231-30Gemfibrozil30 in 1 BLISTER PACKTABLET, FILM COATED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-231GEMFIBROZIL TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 1 package rows20101118_e2ec8e47-8f4e-44cc-82ff-1d4511d3fadd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310459gemfibrozil 600 MG Oral TabletPSNe2ec8e47-8f4e-44cc-82ff-1d4511d3fadd1
310459gemfibrozil 600 MG Oral TabletSCDe2ec8e47-8f4e-44cc-82ff-1d4511d3fadd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67046-231-306704602313030 in 1 BLISTER PACKHistorical