Regulatory PathRegulatory requirements compared

Active substance

Metformin

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
DIALON 1000MG F.C. TABLETS1000 mgFilm-coated tablet · Oral use30 BlisterSAR 6.95Generic · PrescriptionGulf Pharmaceutical Industries (Julphar)Valid
DIALON 500 MG F.C TAB500 mgFilm-coated tablet · Oral use48 BlisterSAR 6.05Generic · PrescriptionGulf Pharmaceutical Industries (Julphar)Valid
DIALON 850MG F.C. TABLETS850 mgFilm-coated tablet · Oral use30 BlisterSAR 3.80Generic · PrescriptionGulf Pharmaceutical Industries (Julphar)Valid
DIAPHAGE 1 G SR TABLET1000 mgTablet · Oral use28 BlisterSAR 23.80Generic · PrescriptionUNITED PHARMACEUTICAL CO.Valid
Diafor XR1000 mgProlonged-release tablet · Oral use56 BlisterSAR 52.85Generic · PrescriptionSaudi AmaroxValid
Diafor XR750 mgProlonged-release tablet · Oral use56 BlisterSAR 39.65Generic · PrescriptionSaudi AmaroxValid
Diafor XR500 mgProlonged-release tablet · Oral use56 BlisterSAR 26.45Generic · PrescriptionSaudi AmaroxValid
Diafor XR1000 mgProlonged-release tablet · Oral use28 BlisterSAR 26.45Generic · PrescriptionSaudi AmaroxValid
Diafor XR750 mgProlonged-release tablet · Oral use28 BlisterSAR 19.85Generic · PrescriptionSaudi AmaroxValid
Diafor XR500 mgProlonged-release tablet · Oral use28 BlisterSAR 13.20Generic · PrescriptionSaudi AmaroxValid
FORMIT 850 MG TABLETS850 mgTablet · Oral use60 BlisterSAR 26.15Generic · PrescriptionSPIMACO ADDWAEIHValid
FORMIT XR 750 MG TABLETS750 mgExtended-release tablet · Oral use30 BlisterSAR 22.50Generic · PrescriptionSPIMACO ADDWAEIHValid
FORMIT XR 750 MG TABLETS750 mgExtended-release tablet · Oral use60 BlisterSAR 45.00Generic · PrescriptionSPIMACO ADDWAEIHValid
Formit XR500 mgExtended-release tablet · Oral use30 BlisterSAR 12.50Generic · PrescriptionSPIMACOValid
Formit XR500 mgExtended-release tablet · Oral use60 BlisterSAR 25.00Generic · PrescriptionSPIMACOValid
GLUCARE 1000 mg XR Tablet1000 mgExtended-release tablet · Oral use60 BlisterSAR 56.65Generic · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
GLUCARE 500MG TAB500 mgFilm-coated tablet · Oral use50 BlisterSAR 14.90Generic · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
GLUCARE 850 TAB.850 mgFilm-coated tablet · Oral use60 BlisterSAR 27.75Generic · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
GLUCARE XR 500 mg tablet500 mgExtended-release tablet · Oral use30 BlisterSAR 15.85Generic · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
GLUCARE XR 500 mg tablet500 mgExtended-release tablet · Oral use60 BlisterSAR 31.70Generic · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
GLUCARE XR 500 mg tablet500 mgExtended-release tablet · Oral use90 BlisterSAR 47.55Generic · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
GLUCARE XR 750 mg tablet750 mgExtended-release tablet · Oral use30 BlisterSAR 23.75Generic · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
GLUCARE XR 750 mg tablet750 mgExtended-release tablet · Oral use60 BlisterSAR 47.50Generic · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
GLUCOPHAGE 1 g tablet1000 mgFilm-coated tablet · Oral use30 BlisterSAR 19.85NCE · PrescriptionMERCK SANTEValid
GLUCOPHAGE 500 mg tablet500 mgFilm-coated tablet · Oral use60 BlisterSAR 19.85Generic · PrescriptionMERCK SANTEValid

34 more — full table

Indications — CHI Daman Drug Formulary

DIABETES MELLITUS TYPE 2; GESTATIONAL DIABETES

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
METFORMIN HYDROCHLORIDE500MG; 850MG; 1GM; 750MG; 625MGtablet · oralCHARTWELLPrescription24 Jan 2002
METFORMIN HYDROCHLORIDE500MG; 850MG; 1GMtablet · oralSENORES PHARMSPrescription24 Jan 2002
METFORMIN HYDROCHLORIDE500MG; 850MG; 1GMtablet · oralEPIC PHARMA LLCPrescription25 Jan 2002
METFORMIN HYDROCHLORIDE500MG; 850MG; 1GMtablet · oralMYLANPrescription25 Jan 2002
METFORMIN HYDROCHLORIDE500MGtablet, extended release · oralTEVAPrescription18 Jun 2004
METFORMIN HYDROCHLORIDE500MGtablet, extended release · oralSANDOZPrescription14 Dec 2004
METFORMIN HYDROCHLORIDE500MG; 850MG; 1GMtablet · oralAUROBINDOPrescription14 Jan 2005
METFORMIN HYDROCHLORIDE750MGtablet, extended release · oralTEVAPrescription12 Apr 2005
METFORMIN HYDROCHLORIDE750MGtablet, extended release · oralACTAVIS LABS FL INCPrescription12 Apr 2005
METFORMIN HYDROCHLORIDE500MG; 850MG; 1GMtablet · oralZYDUS PHARMS USAPrescription18 Apr 2005
METFORMIN HYDROCHLORIDE500MGtablet, extended release · oralZYDUS LIFESCIENCESPrescription20 Apr 2005
METFORMIN HYDROCHLORIDE750MGtablet, extended release · oralZYDUS LIFESCIENCESPrescription21 Apr 2005
METFORMIN HYDROCHLORIDE500MG; 750MGtablet, extended release · oralNOSTRUM PHARMS LLCPrescription26 Jul 2006
METFORMIN HYDROCHLORIDE500MG; 850MG; 1GMtablet · oralDR REDDYS LABS INCPrescription23 Aug 2006
METFORMIN HYDROCHLORIDE500MG; 750MGtablet, extended release · oralCSPC OUYIPrescription17 Apr 2008
METFORMIN HYDROCHLORIDE500MG; 850MG; 1GMtablet · oralGRANULES INDIAPrescription22 Apr 2010
METFORMIN HYDROCHLORIDE500MG; 850MG; 1GMtablet · oralALKEMPrescription1 Nov 2010
METFORMIN HYDROCHLORIDE500MG; 1GMtablet, extended release · oralLUPIN LTDPrescription29 Jun 2011
METFORMIN HYDROCHLORIDE500MGtablet, extended release · oralADAPTISPrescription18 Jan 2012
METFORMIN HYDROCHLORIDE500MG; 850MG; 1GMtablet · oralPHARMAZONEPrescription12 Mar 2012
METFORMIN HYDROCHLORIDE500MG; 750MGtablet, extended release · oralAUROBINDO PHARMA LTDPrescription20 Jul 2012
METFORMIN HYDROCHLORIDE500MG; 1GMtablet, extended release · oralMYLAN PHARMS INCPrescription1 Aug 2012
METFORMIN HYDROCHLORIDE500MG; 1GMtablet, extended release · oralLUPINPrescription19 Jul 2013
METFORMIN HYDROCHLORIDE500MG; 850MG; 1GM; 625MG; 750MGtablet · oralSCIEGEN PHARMSPrescription11 Sep 2013
METFORMIN HYDROCHLORIDE500MG; 850MG; 1GMtablet · oralZYDUS HLTHCAREPrescription28 Aug 2014

85 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
AG-METFORMIN02494418500 MGTABLET · ORALANGITA PHARMA INC.
AG-METFORMIN02494442850 MGTABLET · ORALANGITA PHARMA INC.
APO-METFORMIN ER02305062500 MGTABLET (EXTENDED-RELEASE) · ORALAPOTEX INC
APO-METFORMIN ER024606531000 MGTABLET (EXTENDED-RELEASE) · ORALAPOTEX INC
AURO-METFORMIN02438275500 MGTABLET · ORALAURO PHARMA INC
AURO-METFORMIN02438283850 MGTABLET · ORALAURO PHARMA INC
GLUCOPHAGE02099233500 MGTABLET · ORALSANOFI-AVENTIS CANADA INC
GLUMETZA02268493500 MGTABLET (EXTENDED-RELEASE) · ORALBAUSCH HEALTH, CANADA INC.
GLUMETZA023004511000 MGTABLET (EXTENDED-RELEASE) · ORALBAUSCH HEALTH, CANADA INC.
JAMP METFORMIN02380196500 MGTABLET · ORALJAMP PHARMA CORPORATION
JAMP METFORMIN02380218850 MGTABLET · ORALJAMP PHARMA CORPORATION
M-METFORMIN02547767500 MGTABLET · ORALMANTRA PHARMA INC
M-METFORMIN02547775850 MGTABLET · ORALMANTRA PHARMA INC
M-METFORMIN025482751000 MGTABLET · ORALMANTRA PHARMA INC
M-METFORMIN XR02551845500 MGTABLET (EXTENDED-RELEASE) · ORALMANTRA PHARMA INC
M-METFORMIN XR025518531000 MGTABLET (EXTENDED-RELEASE) · ORALMANTRA PHARMA INC
MAR-METFORMIN02378620500 MGTABLET · ORALMARCAN PHARMACEUTICALS INC
MAR-METFORMIN02378639850 MGTABLET · ORALMARCAN PHARMACEUTICALS INC
MAR-METFORMIN XR02550504500 MGTABLET (EXTENDED-RELEASE) · ORALMARCAN PHARMACEUTICALS INC
MAR-METFORMIN XR025505121000 MGTABLET (EXTENDED-RELEASE) · ORALMARCAN PHARMACEUTICALS INC
METFORMIN02353377500 MGTABLET · ORALSANIS HEALTH INC
METFORMIN02353385850 MGTABLET · ORALSANIS HEALTH INC
METFORMIN02385341500 MGTABLET · ORALSIVEM PHARMACEUTICALS ULC
METFORMIN02385368850 MGTABLET · ORALSIVEM PHARMACEUTICALS ULC
METFORMIN ER02558785500 MGTABLET (EXTENDED-RELEASE) · ORALSANIS HEALTH INC

22 more — full table

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACMETFORMIN ER 1,000 MG GASTR-TB$0.3357per EA23 Sep 2026
US NADACMETFORMIN ER 1,000 MG OSM-TAB$0.31418per EA23 Sep 2026
US NADACMETFORMIN ER 500 MG GASTRC-TB$0.27102per EA23 Sep 2026
US NADACMETFORMIN ER 500 MG OSMOTIC TB$0.1644per EA23 Sep 2026
US NADACMETFORMIN HCL 1,000 MG TABLET$0.02315per EA23 Sep 2026
US NADACMETFORMIN HCL 500 MG TABLET$0.01451per EA23 Sep 2026
US NADACMETFORMIN HCL 500 MG/5 ML SOLN$0.3829per ML23 Sep 2026
US NADACMETFORMIN HCL 625 MG TABLET$12.5266per EA25 Feb 2026
US NADACMETFORMIN HCL 750 MG TABLET$14.605per EA25 Feb 2026
US NADACMETFORMIN HCL 850 MG TABLET$0.02398per EA23 Sep 2026
US NADACMETFORMIN HCL ER 500 MG TABLET$0.02838per EA23 Sep 2026
US NADACMETFORMIN HCL ER 750 MG TABLET$0.05264per EA23 Sep 2026
NHS Drug TariffMetformin 1g modified-release tablets£2.2656 tablet1 Oct 2026
NHS Drug TariffMetformin 1g oral powder sachets sugar free£12.6030 sachet1 Oct 2026
NHS Drug TariffMetformin 1g tablets£2.3828 tablet1 Oct 2026
NHS Drug TariffMetformin 1g/5ml oral solution sugar free£80.00150 ml1 Oct 2026
NHS Drug TariffMetformin 500mg modified-release tablets£1.7356 tablet1 Oct 2026
NHS Drug TariffMetformin 500mg oral powder sachets sugar free£12.6030 sachet1 Oct 2026
NHS Drug TariffMetformin 500mg tablets£0.6728 tablet1 Oct 2026
NHS Drug TariffMetformin 500mg/5ml oral solution sugar free£6.58150 ml1 Oct 2026
NHS Drug TariffMetformin 750mg modified-release tablets£1.1428 tablet1 Oct 2026
NHS Drug TariffMetformin 750mg modified-release tablets£2.2956 tablet1 Oct 2026
NHS Drug TariffMetformin 850mg modified-release tablets£3.2030 tablet1 Oct 2026
NHS Drug TariffMetformin 850mg tablets£1.0256 tablet1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

WHO WHO Model List of Essential Medicines (2025)

  • 18.5.2. Hypoglycaemic agents · core (EML); complementary (EMLc)
    Type 2 diabetes mellitus
    Oral > Solid: 500 mg (hydrochloride)

Safety signals and safety-related labeling changes

  • US FDA 11 Aug 2026 ACTOPLUS MET — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 11 Aug 2026 FORTAMET — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 11 Aug 2026 GLUMETZA — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 11 Aug 2026 INVOKAMET — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 11 Aug 2026 INVOKAMET XR — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 11 Aug 2026 JANUMET — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 11 Aug 2026 JANUMET XR — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 11 Aug 2026 JENTADUETO — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 11 Aug 2026 JENTADUETO XR — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 11 Aug 2026 KAZANO — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 11 Aug 2026 KOMBIGLYZE XR — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 11 Aug 2026 RIOMET ER — safety-related labeling change
    Labeling sections changed: Boxed Warning; Warnings and Precautions; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 11 Aug 2026 SEGLUROMET — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 11 Aug 2026 SYNJARDY — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 11 Aug 2026 SYNJARDY XR — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for metformin →

Combinations containing Metformin

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.