Gemfibrozil

Product NDC
72603-206
11-digit product format
726030206
Labeler code
72603
Product ID
72603-206_cc374f14-1a96-4262-bd13-9f126100050e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gemfibrozil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NorthStar Rx LLC
Application
ANDA202726
Marketing category
ANDA
Marketing start
2015-09-16
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 formatDescriptionMarketing startSampleExclude flagStatus
72603-206-017260302060160 TABLET, FILM COATED in 1 BOTTLE (72603-206-01) 2015-09-16NoNoHistorical
72603-206-0272603020602500 TABLET, FILM COATED in 1 BOTTLE (72603-206-02) 2015-09-16NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Gemfibrozil Tablets, USP Rx onlyA-S Medication Solutions2024-08-30Human Prescription Drug Label1
Gemfibrozil Tablets, USP Rx onlyA-S Medication Solutions2024-08-30Human Prescription Drug Label1
Gemfibrozil Tablets, USP Rx onlyNorthStar Rx LLC | Aurobindo Pharma Limited2024-05-15Human Prescription Drug Label2