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Active ingredient

Gemfibrozil

44 finished FDA listings contain Gemfibrozil as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
GEMFIBROZIL
Dosage forms
Tablet, Tablet, Film Coated
Routes
Oral
Manufacturers / labelers
28
Strengths listed
600 mg/1
Brand names in FDA listings
Lopid

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 4719

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 018422PFIZER PHARMS1981-12-211
ANDA 074270CHARTWELL MOLECULES1993-09-271
ANDA 077836INVAGEN PHARMS2006-07-2713
ANDA 078012EPIC PHARMA LLC2007-03-262
ANDA 079072NORTHSTAR HLTHCARE2010-09-133
ANDA 202726AUROBINDO PHARMA LTD2015-09-168
ANDA 203266CADILA PHARMS LTD2016-06-172
ANDA 204189CADILA2018-08-283
ANDA 214603ASCENT PHARMS INC2021-01-1311

Official labeling on DailyMed

Showing the 12 most recent of 43 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.