Gemfibrozil

Product NDC
68788-6447
11-digit product format
687886447
Labeler code
68788
Product ID
68788-6447_a0ea12b0-6ed4-40f9-b716-570a827bd5c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gemfibrozil
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA077836
Marketing category
ANDA
Marketing start
2016-08-02
Marketing end
0000-00-00
Substance
GEMFIBROZIL
Active strength
600 mg/1
Pharmacologic classes
PPAR alpha [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-6447GEMFIBROZIL TABLET [PREFERRED PHARMACEUTICALS INC.]10Legacy NDC20240509_196f706b-7234-4c53-ada2-93c4df02f178.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-6447-36878864470330 TABLET in 1 BOTTLE (68788-6447-3) 30 tablet2016-08-020000-00-00NoNoCurrent
68788-6447-66878864470660 TABLET in 1 BOTTLE (68788-6447-6) 60 tablet2016-08-020000-00-00NoNoCurrent