Gemfibrozil

Product NDC
57237-163
11-digit product format
572370163
Labeler code
57237
Product ID
57237-163_1a6818d9-bb45-482b-bac6-9cd32027ae3d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gemfibrozil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rising Health, LLC
Application
ANDA202726
Marketing category
ANDA
Marketing start
2015-09-16
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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-163-05EA - Each57237-163b3f6f560-7583-44b1-b1f8-41e4c7bf0c3412016-04-04
57237-163-60EA - Each57237-163c679cfd7-170b-4271-bc67-ba1feb294c3c12016-04-04

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310459gemfibrozil 600 MG Oral TabletPSNf20eb470-a6db-40c2-9113-8023eb0ea4d25
310459gemfibrozil 600 MG Oral TabletSCDf20eb470-a6db-40c2-9113-8023eb0ea4d25
310459gemfibrozil 600 MG Oral TabletPSN4532f5fd-0396-481e-b827-fbf12e0252314
310459gemfibrozil 600 MG Oral TabletSCD4532f5fd-0396-481e-b827-fbf12e0252314

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57237-163-0557237016305500 TABLET, FILM COATED in 1 BOTTLE (57237-163-05) 2015-09-160000-00-00NoNoCurrent
57237-163-605723701636060 TABLET, FILM COATED in 1 BOTTLE (57237-163-60) 2015-09-160000-00-00NoNoCurrent