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.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| ANDA 075972 | CHARTWELL | 2002-01-24 | 7 |
| ANDA 075973 | MYLAN | 2002-01-25 | 4 |
| ANDA 075965 | EPIC PHARMA LLC | 2002-01-25 | 3 |
| ANDA 077095 | AUROBINDO | 2005-01-14 | 26 |
| ANDA 077060 | ZYDUS LIFESCIENCES | 2005-04-20 | 2 |
| ANDA 077078 | ZYDUS LIFESCIENCES | 2005-04-21 | 3 |
| NDA 021748 | SANTARUS INC | 2005-06-03 | 5 |
| ANDA 077336 | SUN PHARM INDS (IN) | 2006-02-09 | 2 |
| ANDA 077880 | AMNEAL PHARMS NY | 2006-06-05 | 5 |
| ANDA 076756 | NOSTRUM PHARMS LLC | 2006-07-26 | 3 |
| ANDA 078596 | AMNEAL PHARMS NY | 2008-01-03 | 6 |
| ANDA 078321 | CSPC OUYI | 2008-04-17 | 26 |
| ANDA 090564 | GRANULES INDIA | 2010-04-22 | 74 |
| ANDA 091184 | ALKEM | 2010-11-01 | 3 |
| ANDA 090692 | LUPIN LTD | 2011-06-29 | 5 |
| ANDA 201991 | ADAPTIS | 2012-01-18 | 15 |
| ANDA 090888 | PHARMAZONE | 2012-03-12 | 6 |
| ANDA 079118 | AUROBINDO PHARMA LTD | 2012-07-20 | 2 |
| ANDA 200690 | MYLAN PHARMS INC | 2012-08-01 | 2 |
| ANDA 091664 | LUPIN | 2013-07-19 | 2 |
| ANDA 203769 | SCIEGEN PHARMS | 2013-09-11 | 45 |
| ANDA 203686 | ZYDUS HLTHCARE | 2014-08-28 | 11 |
| ANDA 090295 | PHARMAZONE | 2016-04-29 | 13 |
| ANDA 205096 | CSPC OUYI | 2016-07-11 | 16 |
| ANDA 207427 | REGCON HOLDINGS | 2016-12-13 | 11 |
| ANDA 202306 | PLATINUM | 2017-02-23 | 2 |
| ANDA 205330 | AARXION ANDA HLDING | 2017-10-31 | 3 |
| ANDA 203832 | MPP PHARMA | 2017-12-26 | 3 |
| ANDA 209313 | GRANULES | 2018-03-16 | 18 |
| ANDA 209882 | LAURUS | 2018-08-27 | 21 |
| ANDA 206145 | ALKEM LABS LTD | 2018-10-22 | 13 |
| ANDA 209674 | NOVAST LABS | 2018-11-02 | 5 |
| ANDA 209993 | QINGDAO BAHEAL PHARM | 2018-12-27 | 6 |
| ANDA 211309 | SAPTALIS PHARMS | 2020-03-03 | 4 |
| ANDA 213651 | AJANTA PHARMA LTD | 2020-04-09 | 3 |
| ANDA 213344 | GRANULES | 2021-01-14 | 5 |
| ANDA 213320 | HARMAN FINOCHEM | 2021-12-03 | 31 |
| ANDA 212681 | PRINSTON INC | 2022-06-09 | 2 |
| ANDA 217631 | LAURUS | 2023-10-05 | 11 |
| ANDA 209694 | AUROBINDO PHARMA | 2024-10-18 | 3 |
Showing 40 of 54 applications.
Official labeling on DailyMed
- METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [GRANULES INDIA LTD] · version 7 · 2026-09-11
- METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [REMEDYREPACK INC.] · version 3 · 2026-09-10
- METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) SOLUTION [CAMBER PHARMACEUTICALS, INC.] · version 2 · 2026-09-10
- METFORMIN (METFORMIN ER 500 MG) TABLET, EXTENDED RELEASE [REMEDYREPACK INC.] · version 5 · 2026-09-10
- METFORMIN HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] · version 1 · 2026-09-03
- METFORMIN HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] · version 1 · 2026-09-03
- METFORMIN HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.] · version 3 · 2026-09-02
- METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [MARLEX PHARMACEUTICALS, INC.] · version 4 · 2026-09-02
- METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [REMEDYREPACK INC.] · version 4 · 2026-08-31
- METFORMIN HYDROCHLORIDE TABLET [SCIEGEN PHARMACEUTICALS INC] · version 10 · 2026-08-31
- METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.] · version 1 · 2026-08-31
- METFORMIN HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] · version 2 · 2026-08-28
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.