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Active ingredient

Glimepiride

104 finished FDA listings contain Glimepiride as their only active ingredient; 4 combination products also contain it.

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FDA NDC Directory

Ingredient names as written by FDA
GLIMEPIRIDE
Dosage forms
Tablet
Routes
Oral
Manufacturers / labelers
29
Strengths listed
1 mg/1 · 2 mg/1 · 3 mg/1 · 4 mg/1 · 6 mg/1 · 8 mg/1
Brand names in FDA listings
Glimepiride 3 Mg

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 25789

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
ANDA 077091DR REDDYS LABS LTD2005-10-0622
ANDA 077370PRINSTON INC2005-12-233
ANDA 078181ACCORD HLTHCARE2007-08-2312
ANDA 077911CARLSBAD2009-09-2212
ANDA 091220MICRO LABS2012-06-2915
ANDA 202759AUROBINDO PHARMA LTD2012-06-2921
ANDA 202112REGCON HOLDINGS2013-04-1719

Official labeling on DailyMed

Showing the 12 most recent of 71 labels.

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