Metformin Hydrochloride

For type 2 diabetes mellitus. Sold as Glucophage, Glucophage Xr, Fortamet, Riomet, Glumetza and 1 more. Every FDA application for this active ingredient: 6 branded and 104 generic.

As of Nov 15, 2026, FDA lists 110 applications for Metformin Hydrochloride (sold as Glucophage, Glucophage Xr, Fortamet and others), first approved Mar 3, 1995, with 4 new uses approved and 0 published complete response letters.

First approved: Mar 3, 1995
Applications: 110
New uses approved: 4
Complete response letters: 0
Medicare spending, 2025: $411M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Metformin HCl	Part D	$210M	+12%	5,813,572
Metformin HCl ER	Part D	$119M	+17%	3,048,771
Metformin ER Gastric	Part D	$69.3M	-19%	21,977
Metformin ER Osmotic	Part D	$12.0M	-10%	26,649
Glumetza	Part D	$1.1M	-94%	89

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

METFORMIN ER 1,000 MG GASTR-TB: $0.337 per unitGeneric · -33% in a year
METFORMIN ER 1,000 MG OSM-TAB: $0.312 per unitGeneric · +3% in a year
METFORMIN ER 500 MG GASTRC-TB: $0.283 per unitGeneric · -24% in a year
METFORMIN ER 500 MG OSMOTIC TB: $0.189 per unitGeneric · +10% in a year
METFORMIN HCL 1,000 MG TABLET: $0.023 per unitGeneric · -2% in a year
METFORMIN HCL 500 MG TABLET: $0.015 per unitGeneric · +2% in a year
METFORMIN HCL 500 MG/5 ML SOLN: $0.359 per MLGeneric · -45% in a year
METFORMIN HCL 625 MG TABLET: $12.53 per unitGeneric · 0% in a year
METFORMIN HCL 750 MG TABLET: $14.61 per unitGeneric · +0% in a year
METFORMIN HCL 850 MG TABLET: $0.024 per unitGeneric · +8% in a year
METFORMIN HCL ER 500 MG TABLET: $0.028 per unitGeneric · -3% in a year
METFORMIN HCL ER 750 MG TABLET: $0.051 per unitGeneric · -4% in a year

Orphan Designations (FDA)

2 designations, 0 approved for the designated use; see all orphan designations

Treatment of progressive myoclonus epilepsy type 2 (Lafora disease)Consorcio Centro de Investigación Biomédica en Red, M.P. (CIBER) · designated Dec 14, 2017
Treatment of pediatric polycystic ovary syndromeEffRx Pharmaceuticals SA · designated May 29, 2014 · withdrawn

Approvals in Japan (PMDA)

PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

MetglucoDrugs with new indications and a new dosage for the induction of ovulation in patients with polycystic ovarian syndrome and for controlled ovarian… · (1) (2) Sumitomo Pharma Co., Ltd. (3) (4) Daiichi Sankyo Espha Co., Ltd. (5) (6) Sumitomo Pharma Promo Co., Ltd. · Sep 16, 2022
MetglucoDrugs with a new dosage indicated for the treatment of type 2 diabetes mellitus (for pediatric use). · Sumitomo Dainippon Pharma Co., Ltd. · Aug 29, 2014
Metgluco, new approvalA drug with a new dosage exceeding the maximum dosage (750 mg/day) of the conventional formulation indicated for the treatment of type 2 diabetes mellitus… · Dainippon Sumitomo Pharma Co., Ltd. · Jan 20, 2010
MelbinDrugs with a new indication and a new dosage for the treatment of type 2 diabetes mellitus in patients who have not responded sufficiently to either (1)… · Nippon Shinyaku Co., Ltd. · May 20, 2009

Shortages

FDA's drug shortage list, as of Nov 13, 2026

Shortage	Status	First posted	Updated
Metformin Hydrochloride Tablet, Extended Release	To Be Discontinued	Oct 22, 2026	Oct 22, 2026

Clinical Trials

366 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


A Research Study Investigating How Well Zenagamtide at Lower Dose Levels Lowers Blood Sugar and Body Weight Compared to Semaglutide at Lower Dose Levels in People With Type 2 Diabetes Treated With Metformin, Sodium-Glucose Cotransporter 2 Inhibitors (SGLT2i), or BothDiabetes Mellitus, Type 2 · Novo Nordisk A/S	Phase 3	Not yet recruiting	Nov 12, 2026
AMBITION 3: A Research Study Investigating How Well Zenagamtide at Higher Dose Levels Lowers Blood Sugar and Body Weight Compared to Semaglutide in People With Type 2 Diabetes Treated With Metformin, SGLT2i, or BothType 2 Diabetes · Novo Nordisk A/S	Phase 3	Not yet recruiting	Nov 12, 2026
A Research Study Investigating How Well Zenagamtide Lowers Blood Sugar and Body Weight Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease Treated With Once Daily Basal Insulin Alone or in Combination With Metformin, SGLT2i, or BothType 2 Diabetes, Chronic Kidney Disease · Novo Nordisk A/S	Phase 3	Not yet recruiting	Nov 12, 2026
Alpha-Lipoic Acid Added to Dapagliflozin and Insulin Resistance in Type 2 DiabetesDiabetes Mellitus, Type 2, Insulin Resistance Syndrome · Fayoum University	Phase 3	Not yet recruiting	Nov 12, 2026
Effect of Proliverenol on Liver Fat and Insulin Resistance in Type 2 DiabetesDiabetes Mellitus, Type 2 · Universitas Sriwijaya	Phase 2	Recruiting	Nov 10, 2026
Fuling Yunhua Granules and Dihuang Baoyuan Granules in Adults With Type 2 Diabetes and Inadequate Glycemic Control on Metformin TherapyDiabetes Mellitus, Type 2 · Beijing Supreme Life Pharmaceutical Technology Co., Ltd.	Phase 2	Not yet recruiting	Nov 10, 2026
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney DiseaseDiabetic Kidney Disease (DKD), Type 2 Diabetes · Beijing University of Chinese Medicine	Phase 2	Active, not recruiting	Oct 30, 2026
Safety and Tolerability of Metformin and Naproxen for Cancer Prevention in Fanconi AnemiaFanconi Anemia, Head and Neck Cancer · Rockefeller University	Phase 1	Recruiting	Oct 28, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Mar 3, 1995	GlucophageNDA 20357 · New molecular entity	Emd Serono Inc	30	Discontinued
Oct 13, 2000	Glucophage XrNDA 21202 · New dosage form	Emd Serono Inc	16	Discontinued
Jan 24, 2002	Metformin HydrochlorideANDA 75972	Chartwell	7	Marketed
Jan 24, 2002	Metformin HydrochlorideANDA 75975	Ivax Sub Teva Pharms	2	Discontinued
Jan 24, 2002	Metformin HydrochlorideANDA 75976	Pharmobedient	10	Discontinued
Jan 24, 2002	Metformin HydrochlorideANDA 75979	Watson Labs	9	Discontinued
Jan 24, 2002	Metformin HydrochlorideANDA 76033	Pharmazone	8	Marketed
Jan 25, 2002	Metformin HydrochlorideANDA 75971	Barr	1	Discontinued
Jan 25, 2002	Metformin HydrochlorideANDA 75961	Watson Labs Florida	10	Discontinued
Jan 25, 2002	Metformin HydrochlorideANDA 75965	Epic Pharma LLC	7	Marketed
Jan 25, 2002	Metformin HydrochlorideANDA 75973	Mylan	11	Marketed
Jan 25, 2002	Metformin HydrochlorideANDA 75978	Heritage Pharma	13	Discontinued
Jan 25, 2002	Metformin HydrochlorideANDA 75985	Sandoz	16	Discontinued
Jan 29, 2002	Metformin HydrochlorideANDA 75969	Pharmobedient	7	Discontinued
Jan 29, 2002	Metformin HydrochlorideANDA 75967	Sun Pharm Inds Inc	15	Discontinued
Feb 21, 2002	Metformin HydrochlorideANDA 76038	Sun Pharm Industries	9	Discontinued
Apr 23, 2002	Metformin HydrochlorideANDA 75984	Apotex	6	Discontinued
Dec 16, 2002	Metformin HydrochlorideANDA 76328	Teva	0	Discontinued
Dec 1, 2003	Metformin HydrochlorideANDA 76545	Ivax Sub Teva Pharms	1	Discontinued
Apr 27, 2004	FortametNDA 21574 · New formulation or manufacturer	Andrx Labs LLC	7	Discontinued
Jun 16, 2004	Metformin HydrochlorideANDA 76172	Actavis Labs Fl Inc	5	Discontinued
Jun 18, 2004	Metformin HydrochlorideANDA 76269	Teva	8	Marketed
Jul 30, 2004	Metformin HydrochlorideANDA 76249	Impax Labs	3	Discontinued
Oct 1, 2004	Metformin HydrochlorideANDA 76450	Actavis Elizabeth	3	Discontinued
Oct 14, 2004	Metformin HydrochlorideANDA 76863	Barr	3	Discontinued
Dec 14, 2004	Metformin HydrochlorideANDA 76223	Sandoz	2	Discontinued
Dec 14, 2004	Metformin HydrochlorideANDA 76873	Sandoz	4	Marketed
Dec 14, 2004	Metformin HydrochlorideANDA 76818	Watson Labs Inc	4	Discontinued
Dec 14, 2004	Metformin HydrochlorideANDA 76706	Apotex	7	Discontinued
Jan 14, 2005	Metformin HydrochlorideANDA 77095	Aurobindo	8	Marketed
Apr 12, 2005	Metformin HydrochlorideANDA 76864	Teva	8	Marketed
Apr 12, 2005	Metformin HydrochlorideANDA 76869	Actavis Labs Fl Inc	5	Marketed
Apr 13, 2005	Metformin HydrochlorideANDA 76878	Actavis Elizabeth	4	Discontinued
Apr 18, 2005	Metformin HydrochlorideANDA 77064	Zydus Pharms USA	9	Marketed
Apr 20, 2005	Metformin HydrochlorideANDA 77060	Zydus Lifesciences	5	Marketed
Apr 21, 2005	Metformin HydrochlorideANDA 77078	Zydus Lifesciences	5	Marketed
Jun 3, 2005	GlumetzaNDA 21748 · New formulation or manufacturer	Santarus Inc	9	Discontinued
Jun 29, 2005	Metformin HydrochlorideANDA 77211	Ranbaxy Labs Ltd	0	Discontinued
Sep 8, 2005	Metformin HydrochlorideANDA 77113	Pharmobedient	5	Discontinued
Sep 13, 2005	Metformin HydrochlorideANDA 76650	Pharmobedient	5	Discontinued
Sep 13, 2005	Metformin HydrochlorideANDA 76985	Impax Labs	3	Discontinued
Nov 25, 2005	Metformin HydrochlorideANDA 76496	Barr	0	Discontinued
Dec 21, 2005	Metformin HydrochlorideANDA 77124	Sun Pharm Industries	4	Discontinued
Feb 9, 2006	Metformin HydrochlorideANDA 77336	Sun Pharm Inds (In)	6	Discontinued
Jun 5, 2006	Metformin HydrochlorideANDA 77880	Amneal Pharms Ny	6	Discontinued
Jul 26, 2006	Metformin HydrochlorideANDA 76756	Nostrum Pharms LLC	4	Marketed
Jul 28, 2006	Metformin HydrochlorideANDA 77853	Provident Pharm	1	Discontinued
Aug 23, 2006	Metformin HydrochlorideANDA 77787	Dr Reddys Labs Inc	5	Marketed
Jan 24, 2007	Metformin HydrochlorideANDA 77711	Torrent Pharms	5	Discontinued
Aug 6, 2007	Metformin HydrochlorideANDA 78422	Ipca Labs Ltd	2	Discontinued
Jan 3, 2008	Metformin HydrochlorideANDA 78596	Amneal Pharms Ny	6	Discontinued
Apr 17, 2008	Metformin HydrochlorideANDA 78321	Cspc Ouyi	4	Marketed
May 23, 2008	Metformin HydrochlorideANDA 78170	Glenmark Pharms Ltd	5	Discontinued
Oct 20, 2008	RiometNDA 21591 · New dosage form	Ranbaxy	8	Discontinued
Nov 25, 2008	Metformin HydrochlorideANDA 79148	Indicus Pharma	4	Discontinued
Dec 30, 2009	Metformin HydrochlorideANDA 90014	Torrent	3	Discontinued
Feb 18, 2010	Metformin HydrochlorideANDA 79226	Torrent Pharms Ltd	2	Discontinued
Apr 22, 2010	Metformin HydrochlorideANDA 90564	Granules India	8	Marketed
Nov 1, 2010	Metformin HydrochlorideANDA 91184	Alkem	4	Marketed
Jun 29, 2011	Metformin HydrochlorideANDA 90692	Lupin Ltd	3	Marketed
Dec 7, 2011	Metformin HydrochlorideANDA 90666	Apotex	3	Discontinued
Jan 18, 2012	Metformin HydrochlorideANDA 201991	Adaptis	1	Marketed
Mar 12, 2012	Metformin HydrochlorideANDA 90888	Pharmazone	3	Marketed
Jul 20, 2012	Metformin HydrochlorideANDA 79118	Aurobindo Pharma Ltd	4	Marketed
Aug 1, 2012	Metformin HydrochlorideANDA 200690	Mylan Pharms Inc	4	Marketed
Jul 19, 2013	Metformin HydrochlorideANDA 91664	Lupin	2	Marketed
Sep 11, 2013	Metformin HydrochlorideANDA 203769	Sciegen Pharms	6	Marketed
Aug 28, 2014	Metformin HydrochlorideANDA 203686	Zydus Hlthcare	5	Marketed
Apr 29, 2016	Metformin HydrochlorideANDA 90295	Pharmazone	3	Marketed
Jul 11, 2016	Metformin HydrochlorideANDA 205096	Cspc Ouyi	3	Marketed
Aug 1, 2016	Metformin HydrochlorideANDA 202917	Sun Pharm	4	Discontinued
Aug 1, 2016	Metformin HydrochlorideANDA 203755	Actavis Labs Fl Inc	0	Marketed
Dec 7, 2016	Metformin HydrochlorideANDA 206955	Macleods Pharms	5	Marketed
Dec 13, 2016	Metformin HydrochlorideANDA 207427	Regcon Holdings	2	Marketed
Feb 23, 2017	Metformin HydrochlorideANDA 202306	Platinum	4	Marketed
Oct 31, 2017	Metformin HydrochlorideANDA 205330	Aarxion Anda Hlding	3	Discontinued
Dec 26, 2017	Metformin HydrochlorideANDA 203832	Mpp Pharma	3	Marketed
Mar 16, 2018	Metformin HydrochlorideANDA 209313	Granules	3	Marketed
Mar 19, 2018	Metformin HydrochlorideANDA 209303	Alignscience Pharma	3	Marketed
Aug 27, 2018	Metformin HydrochlorideANDA 209882	Laurus	3	Marketed
Sep 10, 2018	Metformin HydrochlorideANDA 208880	Prinston	1	Marketed
Sep 24, 2018	Metformin HydrochlorideANDA 211052	Yichang Humanwell	1	Marketed
Oct 12, 2018	Metformin HydrochlorideANDA 208999	Sunshine	1	Discontinued
Oct 22, 2018	Metformin HydrochlorideANDA 206145	Alkem Labs Ltd	1	Marketed
Nov 2, 2018	Metformin HydrochlorideANDA 209674	Novast Labs	1	Marketed
Dec 27, 2018	Metformin HydrochlorideANDA 209993	Qingdao Baheal Pharm	1	Marketed
Aug 29, 2019	Riomet ErNDA 212595 · New dosage form	Sun Pharm	1	Discontinued
Nov 25, 2019	Metformin HydrochlorideANDA 212969	Glenmark Pharms Ltd	0	Marketed
Mar 3, 2020	Metformin HydrochlorideANDA 211309	Saptalis Pharms	2	Marketed
Apr 9, 2020	Metformin HydrochlorideANDA 213651	Ajanta Pharma Ltd	1	Marketed
Jan 14, 2021	Metformin HydrochlorideANDA 213344	Granules	1	Marketed
Mar 9, 2021	Metformin HydrochlorideANDA 213962	Ajanta Pharma Ltd	0	Marketed
Apr 16, 2021	Metformin HydrochlorideANDA 213334	Sciegen Pharms	0	Marketed
Aug 3, 2021	Metformin HydrochlorideANDA 213394	Utopic Pharms	0	Discontinued
Aug 11, 2021	Metformin HydrochlorideANDA 213359	Unichem	1	Marketed
Sep 29, 2021	Metformin HydrochlorideANDA 213247	Twi Pharms	0	Discontinued
Dec 3, 2021	Metformin HydrochlorideANDA 213320	Harman Finochem	2	Marketed
Dec 13, 2021	Metformin HydrochlorideANDA 213356	Apotex	1	Discontinued
Feb 22, 2022	Metformin HydrochlorideANDA 214629	Sciegen Pharms	1	Marketed
Jun 9, 2022	Metformin HydrochlorideANDA 212681	Prinston	0	Marketed
Aug 19, 2022	Metformin HydrochlorideANDA 212677	Vistapharm LLC	1	Marketed
Jan 10, 2023	Metformin HydrochlorideANDA 212448	Micro Labs	0	Marketed
Jun 20, 2023	Metformin HydrochlorideANDA 215629	Pharmazone	0	Discontinued
Oct 5, 2023	Metformin HydrochlorideANDA 217631	Laurus	2	Marketed
Mar 13, 2024	Metformin HydrochlorideANDA 211163	Macleods Pharms	0	Discontinued
Jul 5, 2024	Metformin HydrochlorideANDA 218673	Harman Finochem	1	Marketed
Oct 18, 2024	Metformin HydrochlorideANDA 209694	Aurobindo Pharma	1	Marketed
Mar 13, 2025	Metformin HydrochlorideANDA 215008	Annora Pharma	1	Marketed
Apr 14, 2025	Metformin HydrochlorideANDA 219151	Bionpharma	1	Marketed
—	Metformin HydrochlorideANDA 76413	Ranbaxy Labs Ltd	1	Discontinued

Show all 110

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA