Is Glibenclamide + Metformin registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 6 valid registrations of Glibenclamide + Metformin, including DAONIL M 250/1.25MG TABLETS (250,1.25 mg,mg, Tablet, SAR 8.75); DAONIL M 500/2.5MG TABLETS (500,2.5 mg,mg, Tablet, SAR 14.85); DAONIL M 500/5MG TABLETS (500,5 mg,mg, Tablet, SAR 21.10); GLUCOVANCE 2.5/500 (2.5,500 mg,mg, Film-coated tablet, SAR 16.50); GLUCOVANCE 5/500 (5,500 mg,mg, Film-coated tablet, SAR 23.45).

Is Glibenclamide + Metformin approved by the US FDA?

Drugs@FDA lists 8 application product lines for Glibenclamide + Metformin, including GLYBURIDE AND METFORMIN HYDROCHLORIDE (Prescription); GLYBURIDE AND METFORMIN HYDROCHLORIDE (Prescription); GLYBURIDE AND METFORMIN HYDROCHLORIDE (Prescription); GLYBURIDE AND METFORMIN HYDROCHLORIDE (Prescription); GLYBURIDE AND METFORMIN HYDROCHLORIDE (Prescription).

Active substances

Glibenclamide + Metformin

SFDA 13
US FDA 8
US price lines 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
DAONIL M 250/1.25MG TABLETS	250,1.25 mg,mg	Tablet · Oral use	30 Blister	SAR 8.75	Generic · Prescription	sanofi-aventis	Valid
DAONIL M 500/2.5MG TABLETS	500,2.5 mg,mg	Tablet · Oral use	30 Blister	SAR 14.85	Generic · Prescription	sanofi-aventis	Valid
DAONIL M 500/5MG TABLETS	500,5 mg,mg	Tablet · Oral use	30 Blister	SAR 21.10	Generic · Prescription	sanofi-aventis	Valid
GLUCOVANCE 2.5/500	2.5,500 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 16.50	NCE · Prescription	MERCK SANTE	Valid
GLUCOVANCE 5/500	5,500 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 23.45	NCE · Prescription	MERCK SANTE	Valid
Glucovance	5,1000 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 25.50	NCE · Prescription	MERCK SANTE	Valid
DIAMET 250-1.25MG TABLETS	1.25, 250 mg	Tablet · Oral use	30 Blister	SAR 8.75	Generic · Prescription	SPIMACO ADDWAEIH	Withdrawn by MAH · Not Marketed
DIAMET 500-2.5MG TABLETS	2.5, 500 mg	Film-coated tablet · Oral use	30 Blister	SAR 14.85	Generic · Prescription	SPIMACO ADDWAEIH	Withdrawn by MAH · Not Marketed
DIAMET 500-5MG TABLETS	5, 500 mg	Film-coated tablet · Oral use	30 Blister	SAR 21.10	Generic · Prescription	SPIMACO ADDWAEIH	Withdrawn by MAH · Not Marketed
GLIMIFORT 2.5/500 mg film-coated tablet	2.5, 500 mg	Film-coated tablet · Oral use	30 Blister	SAR 13.35	Generic · Prescription	SANDOZ	Withdrawn by MAH · Not Marketed
GLIMIFORT 5/500 mg film-coated tablet	5, 500 mg	Film-coated tablet · Oral use	30 Blister	SAR 19.00	Generic · Prescription	SANDOZ	Withdrawn by MAH · Not Marketed
GLUCOVANCE	5, 500 mg	Film-coated tablet · Oral use	30 Blister	SAR 23.45	NCE · Prescription	RIYADH PHARMA	Withdrawn by MAH · Not Marketed
GLUCOVANCE	2.5, 500 mg	Film-coated tablet · Oral use	30 Blister	SAR 16.50	NCE · Prescription	RIYADH PHARMA	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

DIABETES MELLITUS TYPE 2

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

Product	Strength	Form · route	Applicant	Status	First approved
GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG; 2.5MG;500MG; 5MG;500MG	tablet · oral	IMPAX	Prescription	18 Feb 2004
GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG; 2.5MG;500MG; 5MG;500MG	tablet · oral	ACTAVIS ELIZABETH	Prescription	28 Jun 2005
GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG; 2.5MG;500MG; 5MG;500MG	tablet · oral	AUROBINDO PHARMA	Prescription	14 Nov 2007
GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG; 2.5MG;500MG; 5MG;500MG	tablet · oral	HERITAGE	Prescription	3 Jun 2009
GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG; 2.5MG;500MG; 5MG;500MG	tablet · oral	ZYDUS PHARMS	Prescription	29 Feb 2016
GLUCOVANCE	1.25MG;250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 2.5MG;500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 5MG;500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet · oral	BRISTOL MYERS SQUIBB	Discontinued	31 Jul 2000
GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG; 2.5MG;500MG; 5MG;500MG	tablet · oral	IMPAX LABS INC	Discontinued	19 Nov 2004
GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG; 2.5MG;500MG; 5MG;500MG	tablet · oral	TEVA	Discontinued	27 Jan 2005

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	GLYBURIDE-METFORMIN 2.5-500 MG	$0.17146	per EA	23 Sep 2026
US NADAC	GLYBURIDE-METFORMIN 5-500 MG	$0.18963	per EA	23 Sep 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.

Components

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.