GEMFIBROZIL

Product NDC
68788-7011
11-digit product format
687887011
Labeler code
68788
Product ID
68788-7011_991b0066-ffdc-4ca5-8aa1-15674bcdedd1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GEMFIBROZIL
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA077836
Marketing category
ANDA
Marketing start
2017-08-28
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
2018-12-31
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
68788-7011-32020-01-31C16284748780-19d75b9d1-10e6-f424-e053-dadaa90a57ceGemfibrozil Tablets, USP Rx Only
68788-7011-62020-01-31C16284748780-19d75b9d1-10e6-f424-e053-dadaa90a57ceGemfibrozil Tablets, USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-7011-3GEMFIBROZIL30 in 1 BOTTLETABLET301
68788-7011-6GEMFIBROZIL60 in 1 BOTTLETABLET601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7011GEMFIBROZIL TABLET [PREFERRED PHARMACEUTICALS INC.]1Legacy NDC, 2 package rows20170829_991b0066-ffdc-4ca5-8aa1-15674bcdedd1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310459gemfibrozil 600 MG Oral TabletPSN991b0066-ffdc-4ca5-8aa1-15674bcdedd11
310459gemfibrozil 600 MG Oral TabletSCD991b0066-ffdc-4ca5-8aa1-15674bcdedd11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68788-7011-36878870110330 in 1 BOTTLEHistorical
68788-7011-66878870110660 in 1 BOTTLEHistorical