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Active ingredient

Metformin

451 finished FDA listings contain Metformin as their only active ingredient; 177 combination products also contain it.

FDA NDC Directory

Ingredient names as written by FDA
METFORMIN HYDROCHLORIDE
Dosage forms
Solution, Tablet, Tablet, Coated, Tablet, Extended Release, Tablet, Film Coated, Tablet, Film Coated, Extended Release
Routes
Oral
Manufacturers / labelers
85
Strengths listed
1000 mg/1 · 500 mg/1 · 500 mg/5ml · 625 mg/1 · 750 mg/1 · 850 mg/1
Brand names in FDA listings
Glumetza, Metformin, Metformin Hydrochloride, Metformin Hydrochloride Er, Metformin Hydrochloride Extended Release, Metformin Hydrochloride Extended-Release 500mg, Metformin Hydrochloride Oral Solution, Riomet

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 6809

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 075972CHARTWELL2002-01-247
ANDA 075973MYLAN2002-01-254
ANDA 075965EPIC PHARMA LLC2002-01-253
ANDA 077095AUROBINDO2005-01-1426
ANDA 077060ZYDUS LIFESCIENCES2005-04-202
ANDA 077078ZYDUS LIFESCIENCES2005-04-213
NDA 021748SANTARUS INC2005-06-035
ANDA 077336SUN PHARM INDS (IN)2006-02-092
ANDA 077880AMNEAL PHARMS NY2006-06-055
ANDA 076756NOSTRUM PHARMS LLC2006-07-263
ANDA 078596AMNEAL PHARMS NY2008-01-036
ANDA 078321CSPC OUYI2008-04-1726
ANDA 090564GRANULES INDIA2010-04-2274
ANDA 091184ALKEM2010-11-013
ANDA 090692LUPIN LTD2011-06-295
ANDA 201991ADAPTIS2012-01-1815
ANDA 090888PHARMAZONE2012-03-126
ANDA 079118AUROBINDO PHARMA LTD2012-07-202
ANDA 200690MYLAN PHARMS INC2012-08-012
ANDA 091664LUPIN2013-07-192
ANDA 203769SCIEGEN PHARMS2013-09-1145
ANDA 203686ZYDUS HLTHCARE2014-08-2811
ANDA 090295PHARMAZONE2016-04-2913
ANDA 205096CSPC OUYI2016-07-1116
ANDA 207427REGCON HOLDINGS2016-12-1311
ANDA 202306PLATINUM2017-02-232
ANDA 205330AARXION ANDA HLDING2017-10-313
ANDA 203832MPP PHARMA2017-12-263
ANDA 209313GRANULES2018-03-1618
ANDA 209882LAURUS2018-08-2721
ANDA 206145ALKEM LABS LTD2018-10-2213
ANDA 209674NOVAST LABS2018-11-025
ANDA 209993QINGDAO BAHEAL PHARM2018-12-276
ANDA 211309SAPTALIS PHARMS2020-03-034
ANDA 213651AJANTA PHARMA LTD2020-04-093
ANDA 213344GRANULES2021-01-145
ANDA 213320HARMAN FINOCHEM2021-12-0331
ANDA 212681PRINSTON INC2022-06-092
ANDA 217631LAURUS2023-10-0511
ANDA 209694AUROBINDO PHARMA2024-10-183

Showing 40 of 54 applications.

Official labeling on DailyMed

Showing the 12 most recent of 302 labels.

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