Gemfibrozil

Product NDC
55700-493
11-digit product format
557000493
Labeler code
55700
Product ID
55700-493_d592200f-e309-4e59-a6b2-35cfe849de69
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gemfibrozil
Dosage form
TABLET
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA077836
Marketing category
ANDA
Marketing start
2016-10-13
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

FDA-Initiated Inactive NDC Indexing#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-493-905570004939090 TABLET in 1 BOTTLE (55700-493-90) 90 tablet2017-02-060000-00-00NoNoCurrent