GEMFIBROZIL

Product NDC
72162-2119
11-digit product format
721622119
Labeler code
72162
Product ID
72162-2119_cfb9ebc5-4268-4d5b-a5db-1078913644bf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gemfibrozil
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA214603
Marketing category
ANDA
Marketing start
2021-01-20
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
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
Q8X02027X3GEMFIBROZIL25812-30-0GEMFIBROZIL

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2119-67216221190660 TABLET in 1 BOTTLE (72162-2119-6) 60 tablet2023-09-15NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Gemfibrozil Tablets, USPBryant Ranch Prepack2023-09-15HUMAN PRESCRIPTION DRUG LABEL100