Is Glibenclamide registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 3 valid registrations of Glibenclamide, including DAONIL 5MG TAB (5 mg, Tablet, SAR 24.60); GLIBIL-5 TABS (5 mg, Tablet, SAR 9.75); Glibil (5 mg, Tablet, SAR 173.20).

Is Glibenclamide approved by the US FDA?

Drugs@FDA lists 19 application product lines for Glibenclamide, including DIABETA (Prescription); GLYBURIDE (Prescription); GLYBURIDE (MICRONIZED) (Prescription); GLYBURIDE (Prescription); GLYBURIDE (Prescription).

Is Glibenclamide authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Glibenclamide: Amglidia.

Are there safety signals or safety updates for Glibenclamide?

US FDA: 2 entries (latest 2018-12-27).

Active substance

Glibenclamide

SFDA 13
US FDA 19
EMA 1
Health Canada 4
US price lines 3
Safety 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 5MG TAB	5 mg	Tablet · Oral use	30 Blister	SAR 24.60	NCE · Prescription	sanofi-aventis FRANCE	Valid
GLIBIL-5 TABS	5 mg	Tablet · Oral use	30 Blister	SAR 9.75	Generic · Prescription	Hikma Pharmaceuticals PLC	Valid
Glibil	5 mg	Tablet · Oral use	1000 Blister	SAR 173.20	Generic · Prescription	Hikma Pharmaceuticals PLC	Valid
APO-GLYBURIDE 5MG TAB	5 mg	Tablet · Oral use	100 Blister	SAR 37.95	Generic · Prescription	APOTEX	Withdrawn by MAH · Not Marketed
APO-GLYBURIDE 5MG TAB	5 mg	Tablet · Oral use	30 Tablet Container	SAR 12.65	Generic · Prescription	APOTEX	Withdrawn by MAH · Not Marketed
DIATAB 5MG TAB	5 mg	Tablet · Oral use	30 Blister	SAR 20.55	Generic · Prescription	SPIMACO ADDWAEIH	Withdrawn by MAH · Not Marketed
DOABETIC 5 MG TABLET	5 mg	Tablet · Oral use	30 Blister	SAR 18.60	Generic · Prescription	KUWAIT SAUDI PHARMACEUTICAL INDUSTRIES	Withdrawn by regulatory authority · Not Marketed
EUGLUCON 5MG TAB	5 mg	Tablet · Oral use	30 Blister	SAR 13.60	Generic · Prescription	ROCHE	Withdrawn by MAH · Not Marketed
GLYMIDE 5MG TABLETS	5 mg	Tablet · Oral use	30 Blister	SAR 16.75	Generic · Prescription	Gulf Pharmaceutical Industries (Julphar)	Withdrawn by regulatory authority · Not Marketed
MICRONASE 5Mg TABLET	5 mg	Tablet · Oral use	100 Tablet Container	SAR 58.25	Generic · Prescription	PHARMACIA UPJOHN	Withdrawn by MAH · Not Marketed
MICRONASE 5Mg TABLET	5 mg	Tablet · Oral use	30 Tablet Container	SAR 19.65	Generic · Prescription	PHARMACIA UPJOHN	Withdrawn by MAH · Not Marketed
NOVO-GLYBURIDE 5MG TAB	5 mg	Tablet · Oral use	30 Blister	SAR 19.20	Generic · Prescription	NOVOPHARM	Withdrawn by MAH · Not Marketed
NOVO-GLYBURIDE 5MG TAB	5 mg	Tablet · Oral use	100 Tablet Container	SAR 60.45	Generic · Prescription	NOVOPHARM	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

DIABETES MELLITUS TYPE 2; GESTATIONAL DIABETES

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

Product	Strength	Form · route	Applicant	Status	First approved
DIABETA	1.25MG; 2.5MG; 5MG	tablet · oral	SANOFI AVENTIS US	Prescription	1 May 1984
GLYBURIDE	1.25MG; 2.5MG; 5MG	tablet · oral	TEVA	Prescription	29 Aug 1995
GLYBURIDE (MICRONIZED)	1.5MG; 3MG; 4.5MG; 6MG	tablet · oral	TEVA	Prescription	20 Apr 1999
GLYBURIDE	1.25MG; 2.5MG; 5MG	tablet · oral	EPIC PHARMA LLC	Prescription	27 Jun 2002
GLYBURIDE	1.25MG; 2.5MG; 5MG	tablet · oral	HERITAGE	Prescription	28 Feb 2011
GLYBURIDE	1.25MG; 2.5MG; 5MG	tablet · oral	IMPAX LABS INC	Prescription	30 Sep 2015
GLYBURIDE	1.25mg; 2.5mg; 5MG	tablet · oral	ZYDUS PHARMS	Prescription	10 May 2016
GLYBURIDE	1.25MG; 2.5MG; 5MG	tablet · oral	CADILA PHARMS LTD	Prescription	4 Jan 2019
GLYBURIDE	1.25MG; 2.5MG; 5MG	tablet · oral	ORIENT PHARMA CO LTD	Prescription	22 Feb 2019
MICRONASE	1.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 2.5MG; 5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet · oral	PFIZER	Discontinued	1 May 1984
GLYNASE	1.5MG; 3MG; 4.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 6MG	tablet · oral	PFIZER	Discontinued	4 Mar 1992
GLYBURIDE (MICRONIZED)	1.5MG; 3MG; 6MG	tablet · oral	SANOFI AVENTIS US	Discontinued	17 Apr 1992
GLYBURIDE (MICRONIZED)	1.5MG; 3MG; 4.5MG; 6MG	tablet · oral	STRIDES PHARMA INTL	Discontinued	22 Dec 1997
GLYBURIDE (MICRONIZED)	1.5MG; 3MG	tablet · oral	CHARTWELL RX	Discontinued	22 Jun 1998
GLYBURIDE (MICRONIZED)	1.5MG; 3MG; 6MG	tablet · oral	NATCO PHARMA	Discontinued	26 Jun 1998
GLYBURIDE	1.5MG; 3MG; 6MG	tablet · oral	ACTAVIS ELIZABETH	Discontinued	14 Nov 2002
GLYBURIDE (MICRONIZED)	1.5MG; 3MG; 6MG	tablet · oral	HIKMA	Discontinued	31 Jul 2003
GLYBURIDE	1.25MG; 2.5MG; 5MG	tablet · oral	AUROBINDO PHARMA	Discontinued	18 Oct 2007
GLYBURIDE	1.25MG; 2.5MG; 5MG	tablet · oral	CHARTWELL RX	Discontinued	14 Apr 2016

EMA European Union — centrally authorised medicines

Amglidia Ammtek · Authorised · authorised 24 May 2018 · ATC A10BB01

Therapeutic indication (EMA)

Amglidia is indicated for the treatment of neonatal diabetes mellitus, for use in newborns, infants and children. Sulphonylureas like Amglidia have been shown to be effective in patients with mutations in the genes coding for the ?-cell ATP-sensitive potassium channel and chromosome 6q24-related transient neonatal diabetes mellitus.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
APO GLYBURIDE TAB 2.5MG	01913654	2.5 MG	TABLET · ORAL	APOTEX INC
APO GLYBURIDE TAB 5MG	01913662	5 MG	TABLET · ORAL	APOTEX INC
TEVA-GLYBURIDE	01913670	2.5 MG	TABLET · ORAL	TEVA CANADA LIMITED
TEVA-GLYBURIDE	01913689	5 MG	TABLET · ORAL	TEVA CANADA LIMITED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	GLYBURIDE 1.25 MG TABLET	$0.06059	per EA	23 Sep 2026
US NADAC	GLYBURIDE 2.5 MG TABLET	$0.06331	per EA	23 Sep 2026
US NADAC	GLYBURIDE 5 MG TABLET	$0.06427	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.

Safety signals and safety-related labeling changes

US FDA 27 Dec 2018 GLUCOVANCE — 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 Jan 2017 DIABETA — safety-related labeling change
Labeling sections changed: Adverse Reactions

All safety entries for glibenclamide →

Combinations containing Glibenclamide

Glibenclamide + 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.