FDA Orange Book · active-ingredient family
Metformin hydrochloride
Metformin hydrochloride: 6 brands, 104 generics; first approved Mar 03, 1995; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 104 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
6
Generics (ANDA)
104
Listed patents
1
Next patent expiry
May 01, 2035
in 8 yr 8 mo
Brand (NDA) products
Originator applications
- RIOMET ERRLDSUN PHARMNDA 2125952019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/5ML FOR SUSPENSION, EXTENDED RELEASE ORAL Discontinued — - GLUMETZARLDSANTARUS INCNDA 02174820052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Discontinued — 1GM TABLET, EXTENDED RELEASE ORAL Discontinued — - FORTAMETRLDANDRX LABS LLCNDA 02157420042 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Discontinued — 1GM TABLET, EXTENDED RELEASE ORAL Discontinued — - RIOMETRLDRANBAXYNDA 0215912003
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/5ML SOLUTION ORAL Discontinued — - EMD SERONO INCNDA 02120220002 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Discontinued — 750MG TABLET, EXTENDED RELEASE ORAL Discontinued — - GLUCOPHAGERLDEMD SERONO INCNDA 02035719985 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued — 850MG TABLET ORAL Discontinued — 625MG TABLET ORAL Discontinued — 750MG TABLET ORAL Discontinued — 1GM TABLET ORAL Discontinued —
Generic (ANDA) products (104)
Abbreviated applications
- METFORMIN HYDROCHLORIDEBIONPHARMAANDA 2191512025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/5ML SOLUTION ORAL Rx AB - METFORMIN HYDROCHLORIDEANNORA PHARMAANDA 2150082025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/5ML SOLUTION ORAL Rx AB - METFORMIN HYDROCHLORIDEAUROBINDO PHARMAANDA 20969420242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB2 1GM TABLET, EXTENDED RELEASE ORAL Rx AB2 - METFORMIN HYDROCHLORIDEHARMAN FINOCHEMANDA 21867320242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB1 750MG TABLET, EXTENDED RELEASE ORAL Rx AB - METFORMIN HYDROCHLORIDEMACLEODS PHARMSANDA 2111632024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM TABLET, EXTENDED RELEASE ORAL Discontinued — - METFORMIN HYDROCHLORIDELAURUSANDA 21763120232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB1 750MG TABLET, EXTENDED RELEASE ORAL Rx AB - METFORMIN HYDROCHLORIDESENORES PHARMSANDA 21562920232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Discontinued — 1GM TABLET, EXTENDED RELEASE ORAL Discontinued — - METFORMIN HYDROCHLORIDEMICRO LABSANDA 21244820232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB3 1GM TABLET, EXTENDED RELEASE ORAL Rx AB3 - METFORMIN HYDROCHLORIDEVISTAPHARM LLCANDA 2126772022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/5ML SOLUTION ORAL Rx AB - METFORMIN HYDROCHLORIDEPRINSTON INCANDA 21268120222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB3 1GM TABLET, EXTENDED RELEASE ORAL Rx AB3 - METFORMIN HYDROCHLORIDESCIEGEN PHARMSANDA 21462920222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB2 1GM TABLET, EXTENDED RELEASE ORAL Rx AB2 - METFORMIN HYDROCHLORIDEAPOTEXANDA 21335620212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Discontinued — 1GM TABLET, EXTENDED RELEASE ORAL Discontinued — - METFORMIN HYDROCHLORIDEHARMAN FINOCHEMANDA 21332020213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Rx AB 850MG TABLET ORAL Rx AB 1GM TABLET ORAL Rx AB - METFORMIN HYDROCHLORIDETWI PHARMSANDA 21324720212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Discontinued — 1GM TABLET, EXTENDED RELEASE ORAL Discontinued — - METFORMIN HYDROCHLORIDEUNICHEMANDA 21335920212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB1 750MG TABLET, EXTENDED RELEASE ORAL Rx AB - METFORMIN HYDROCHLORIDEUTOPIC PHARMSANDA 21339420212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Discontinued — 1GM TABLET, EXTENDED RELEASE ORAL Discontinued — - METFORMIN HYDROCHLORIDESCIEGEN PHARMSANDA 21333420212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB3 1GM TABLET, EXTENDED RELEASE ORAL Rx AB3 - METFORMIN HYDROCHLORIDERSAJANTA PHARMA LTDANDA 21396220212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB3 1GM TABLET, EXTENDED RELEASE ORAL Rx AB3 - METFORMIN HYDROCHLORIDEGRANULESANDA 21334420212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB3 1GM TABLET, EXTENDED RELEASE ORAL Rx AB3 - METFORMIN HYDROCHLORIDEAJANTA PHARMA LTDANDA 21365120202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB2 1GM TABLET, EXTENDED RELEASE ORAL Rx AB2 - METFORMIN HYDROCHLORIDERSSAPTALIS PHARMSANDA 2113092020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/5ML SOLUTION ORAL Rx AB - METFORMIN HYDROCHLORIDEGLENMARK PHARMS LTDANDA 21296920192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB3 1GM TABLET, EXTENDED RELEASE ORAL Rx AB3 - METFORMIN HYDROCHLORIDEQINGDAO BAHEAL PHARMANDA 20999320182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB2 1GM TABLET, EXTENDED RELEASE ORAL Rx AB2 - METFORMIN HYDROCHLORIDENOVAST LABSANDA 20967420182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB2 1GM TABLET, EXTENDED RELEASE ORAL Rx AB2 - METFORMIN HYDROCHLORIDEALKEM LABS LTDANDA 20614520182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB1 750MG TABLET, EXTENDED RELEASE ORAL Rx AB - METFORMIN HYDROCHLORIDESUNSHINEANDA 20899920183 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued — 850MG TABLET ORAL Discontinued — 1GM TABLET ORAL Discontinued — - METFORMIN HYDROCHLORIDEYICHANG HUMANWELLANDA 21105220182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB1 750MG TABLET, EXTENDED RELEASE ORAL Rx AB - METFORMIN HYDROCHLORIDEPRINSTON INCANDA 20888020182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB1 750MG TABLET, EXTENDED RELEASE ORAL Rx AB - METFORMIN HYDROCHLORIDELAURUSANDA 20988220183 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Rx AB 850MG TABLET ORAL Rx AB 1GM TABLET ORAL Rx AB - METFORMIN HYDROCHLORIDEALIGNSCIENCE PHARMAANDA 2093032018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB1 - METFORMIN HYDROCHLORIDEGRANULESANDA 20931320182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB1 750MG TABLET, EXTENDED RELEASE ORAL Rx AB - METFORMIN HYDROCHLORIDEMPP PHARMAANDA 20383220172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB2 1GM TABLET, EXTENDED RELEASE ORAL Rx AB2 - METFORMIN HYDROCHLORIDEAARXION ANDA HLDINGANDA 20533020173 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued — 850MG TABLET ORAL Discontinued — 1GM TABLET ORAL Discontinued — - METFORMIN HYDROCHLORIDEPLATINUMANDA 20230620172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB1 750MG TABLET, EXTENDED RELEASE ORAL Rx AB - METFORMIN HYDROCHLORIDEREGCON HOLDINGSANDA 20742720162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB1 750MG TABLET, EXTENDED RELEASE ORAL Rx AB - METFORMIN HYDROCHLORIDEMACLEODS PHARMSANDA 20695520162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB1 750MG TABLET, EXTENDED RELEASE ORAL Rx AB - METFORMIN HYDROCHLORIDEACTAVIS LABS FL INCANDA 20375520162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB3 1GM TABLET, EXTENDED RELEASE ORAL Rx AB3 - METFORMIN HYDROCHLORIDESUN PHARMANDA 20291720162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Discontinued — 1GM TABLET, EXTENDED RELEASE ORAL Discontinued — - METFORMIN HYDROCHLORIDECSPC OUYIANDA 20509620163 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Rx AB 850MG TABLET ORAL Rx AB 1GM TABLET ORAL Rx AB - METFORMIN HYDROCHLORIDEMARKSANS PHARMAANDA 09029520162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB1 750MG TABLET, EXTENDED RELEASE ORAL Rx AB - METFORMIN HYDROCHLORIDEZYDUS HLTHCAREANDA 20368620143 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Rx AB 850MG TABLET ORAL Rx AB 1GM TABLET ORAL Rx AB - METFORMIN HYDROCHLORIDESCIEGEN PHARMSANDA 20376920135 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Rx AB 850MG TABLET ORAL Rx AB 1GM TABLET ORAL Rx AB 625MG TABLET ORAL Rx AB 750MG TABLET ORAL Rx AB - METFORMIN HYDROCHLORIDELUPINANDA 09166420132 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB3 1GM TABLET, EXTENDED RELEASE ORAL Rx AB3 - METFORMIN HYDROCHLORIDEMYLAN PHARMS INCANDA 20069020122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB2 1GM TABLET, EXTENDED RELEASE ORAL Rx AB2 - METFORMIN HYDROCHLORIDEAUROBINDO PHARMA LTDANDA 07911820122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB1 750MG TABLET, EXTENDED RELEASE ORAL Rx AB - METFORMIN HYDROCHLORIDEMARKSANS PHARMAANDA 09088820123 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Rx AB 850MG TABLET ORAL Rx AB 1GM TABLET ORAL Rx AB - METFORMIN HYDROCHLORIDEINVENTIAANDA 2019912012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB1 - METFORMIN HYDROCHLORIDEAPOTEXANDA 09066620113 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued — 850MG TABLET ORAL Discontinued — 1GM TABLET ORAL Discontinued — - METFORMIN HYDROCHLORIDERSLUPIN LTDANDA 09069220112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB2 1GM TABLET, EXTENDED RELEASE ORAL Rx AB2 - METFORMIN HYDROCHLORIDEALKEMANDA 09118420103 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Rx AB 850MG TABLET ORAL Rx AB 1GM TABLET ORAL Rx AB - METFORMIN HYDROCHLORIDERSGRANULES INDIAANDA 09056420103 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Rx AB 850MG TABLET ORAL Rx AB 1GM TABLET ORAL Rx AB - METFORMIN HYDROCHLORIDETORRENT PHARMS LTDANDA 0792262010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 750MG TABLET, EXTENDED RELEASE ORAL Discontinued — - METFORMIN HYDROCHLORIDETORRENTANDA 0900142009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Discontinued — - METFORMIN HYDROCHLORIDEINDICUS PHARMAANDA 07914820083 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued — 850MG TABLET ORAL Discontinued — 1GM TABLET ORAL Discontinued — - METFORMIN HYDROCHLORIDEGLENMARK PHARMS LTDANDA 07817020083 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued — 850MG TABLET ORAL Discontinued — 1GM TABLET ORAL Discontinued — - METFORMIN HYDROCHLORIDECSPC OUYIANDA 07832120082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB1 750MG TABLET, EXTENDED RELEASE ORAL Rx AB - METFORMIN HYDROCHLORIDEAMNEAL PHARMS NYANDA 07859620082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Discontinued — 750MG TABLET, EXTENDED RELEASE ORAL Discontinued — - METFORMIN HYDROCHLORIDEIPCA LABS LTDANDA 07842220073 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued — 850MG TABLET ORAL Discontinued — 1GM TABLET ORAL Discontinued — - METFORMIN HYDROCHLORIDETORRENT PHARMSANDA 07771120073 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued — 850MG TABLET ORAL Discontinued — 1GM TABLET ORAL Discontinued — - METFORMIN HYDROCHLORIDEDR REDDYS LABS INCANDA 07778720063 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Rx AB 850MG TABLET ORAL Rx AB 1GM TABLET ORAL Rx AB - METFORMIN HYDROCHLORIDEPROVIDENT PHARMANDA 07785320063 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued — 850MG TABLET ORAL Discontinued — 1GM TABLET ORAL Discontinued — - METFORMIN HYDROCHLORIDENOSTRUM PHARMS LLCANDA 07675620062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB1 750MG TABLET, EXTENDED RELEASE ORAL Rx AB - METFORMIN HYDROCHLORIDEAMNEAL PHARMS NYANDA 07788020063 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued — 850MG TABLET ORAL Discontinued — 1GM TABLET ORAL Discontinued — - METFORMIN HYDROCHLORIDESUN PHARM INDS (IN)ANDA 07733620062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Discontinued — 750MG TABLET, EXTENDED RELEASE ORAL Discontinued — - METFORMIN HYDROCHLORIDESUN PHARM INDUSTRIESANDA 0771242005
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Discontinued — - METFORMIN HYDROCHLORIDEBARRANDA 0764962005
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Discontinued — - METFORMIN HYDROCHLORIDEIMPAX LABSANDA 0769852005
Approved strengths under this FDA application. Strength Dosage form Route Status TE 750MG TABLET, EXTENDED RELEASE ORAL Discontinued — - METFORMIN HYDROCHLORIDEPHARMOBEDIENTANDA 0766502005
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Discontinued — - METFORMIN HYDROCHLORIDEPHARMOBEDIENTANDA 0771132005
Approved strengths under this FDA application. Strength Dosage form Route Status TE 750MG TABLET, EXTENDED RELEASE ORAL Discontinued — - METFORMIN HYDROCHLORIDERANBAXY LABS LTDANDA 0772112005
Approved strengths under this FDA application. Strength Dosage form Route Status TE 750MG TABLET, EXTENDED RELEASE ORAL Discontinued — - METFORMIN HYDROCHLORIDEZYDUS LIFESCIENCESANDA 0770782005
Approved strengths under this FDA application. Strength Dosage form Route Status TE 750MG TABLET, EXTENDED RELEASE ORAL Rx AB - METFORMIN HYDROCHLORIDEZYDUS LIFESCIENCESANDA 0770602005
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB1 - METFORMIN HYDROCHLORIDEZYDUS PHARMS USAANDA 07706420053 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Rx AB 850MG TABLET ORAL Rx AB 1GM TABLET ORAL Rx AB - METFORMIN HYDROCHLORIDEACTAVIS ELIZABETHANDA 0768782005
Approved strengths under this FDA application. Strength Dosage form Route Status TE 750MG TABLET, EXTENDED RELEASE ORAL Discontinued — - METFORMIN HYDROCHLORIDEACTAVIS LABS FL INCANDA 0768692005
Approved strengths under this FDA application. Strength Dosage form Route Status TE 750MG TABLET, EXTENDED RELEASE ORAL Rx AB - METFORMIN HYDROCHLORIDETEVAANDA 0768642005
Approved strengths under this FDA application. Strength Dosage form Route Status TE 750MG TABLET, EXTENDED RELEASE ORAL Rx AB - METFORMIN HYDROCHLORIDEAUROBINDOANDA 07709520053 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Rx AB 850MG TABLET ORAL Rx AB 1GM TABLET ORAL Rx AB - METFORMIN HYDROCHLORIDEAPOTEXANDA 07670620042 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Discontinued — 750MG TABLET, EXTENDED RELEASE ORAL Discontinued — - METFORMIN HYDROCHLORIDESANDOZANDA 0762232004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Discontinued — - METFORMIN HYDROCHLORIDESANDOZANDA 0768732004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB1 - METFORMIN HYDROCHLORIDEWATSON LABS INCANDA 0768182004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Discontinued — - METFORMIN HYDROCHLORIDEBARRANDA 0768632004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 750MG TABLET, EXTENDED RELEASE ORAL Discontinued — - METFORMIN HYDROCHLORIDEACTAVIS ELIZABETHANDA 0764502004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Discontinued — - METFORMIN HYDROCHLORIDEIMPAX LABSANDA 0762492004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Discontinued — - METFORMIN HYDROCHLORIDERANBAXY LABS LTDANDA 0764132004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Discontinued — - METFORMIN HYDROCHLORIDETEVAANDA 0762692004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB1 - METFORMIN HYDROCHLORIDEACTAVIS LABS FL INCANDA 0761722004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Discontinued — - METFORMIN HYDROCHLORIDEIVAX SUB TEVA PHARMSANDA 0765452003
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Discontinued — - METFORMIN HYDROCHLORIDETEVAANDA 07632820023 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued — 850MG TABLET ORAL Discontinued — 1GM TABLET ORAL Discontinued — - METFORMIN HYDROCHLORIDEHERITAGE PHARMAANDA 07597820023 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued — 850MG TABLET ORAL Discontinued — 1GM TABLET ORAL Discontinued — - METFORMIN HYDROCHLORIDEAPOTEXANDA 07598420023 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued — 850MG TABLET ORAL Discontinued — 1GM TABLET ORAL Discontinued — - METFORMIN HYDROCHLORIDESUN PHARM INDUSTRIESANDA 07603820023 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued — 850MG TABLET ORAL Discontinued — 1GM TABLET ORAL Discontinued — - METFORMIN HYDROCHLORIDEPHARMOBEDIENTANDA 07596920023 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued — 850MG TABLET ORAL Discontinued — 1GM TABLET ORAL Discontinued — - METFORMIN HYDROCHLORIDESUN PHARM INDS INCANDA 07596720023 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued — 850MG TABLET ORAL Discontinued — 1GM TABLET ORAL Discontinued — - METFORMIN HYDROCHLORIDEBARRANDA 07597120023 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued — 850MG TABLET ORAL Discontinued — 1GM TABLET ORAL Discontinued — - METFORMIN HYDROCHLORIDEEPIC PHARMA LLCANDA 07596520023 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Rx AB 850MG TABLET ORAL Rx AB 1GM TABLET ORAL Rx AB - METFORMIN HYDROCHLORIDEMYLANANDA 07597320023 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Rx AB 850MG TABLET ORAL Rx AB 1GM TABLET ORAL Rx AB - METFORMIN HYDROCHLORIDESANDOZANDA 07598520023 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued — 850MG TABLET ORAL Discontinued — 1GM TABLET ORAL Discontinued — - METFORMIN HYDROCHLORIDEWATSON LABS FLORIDAANDA 07596120023 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued — 850MG TABLET ORAL Discontinued — 1GM TABLET ORAL Discontinued — - METFORMIN HYDROCHLORIDECHARTWELLANDA 07597220025 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Rx AB 850MG TABLET ORAL Rx AB 1GM TABLET ORAL Rx AB 750MG TABLET ORAL Rx AB 625MG TABLET ORAL Rx AB - METFORMIN HYDROCHLORIDEIVAX SUB TEVA PHARMSANDA 07597520025 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued — 850MG TABLET ORAL Discontinued — 1GM TABLET ORAL Discontinued — 625MG TABLET ORAL Discontinued — 750MG TABLET ORAL Discontinued — - METFORMIN HYDROCHLORIDEPHARMOBEDIENTANDA 07597620023 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued — 850MG TABLET ORAL Discontinued — 1GM TABLET ORAL Discontinued — - METFORMIN HYDROCHLORIDESENORES PHARMSANDA 07603320023 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Rx AB 850MG TABLET ORAL Rx AB 1GM TABLET ORAL Rx AB - METFORMIN HYDROCHLORIDEWATSON LABSANDA 07597920023 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued — 850MG TABLET ORAL Discontinued — 1GM TABLET ORAL Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 9962336 | in 8 yr 8 mo | Product |
Approval history
FDA approval span
First approval
32 yr 1 mo ago
Most recent approval
8 mo ago
Approvals span 1995–2026 across 110 FDA applications.
Brand (NDA) 65%
Generic (ANDA) 10495%
Metformin hydrochloride: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
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- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
