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Medicine

Glyburide 5 mg tablet

Glyburide · Oral
Available on requestPrescription onlyUS FDAGeneric name

Glyburide 5 mg tablet is a generic prescription medicine for oral use, made by 13 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.

Availability

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Ambient

Store at 20° to 25°C (68° to 77°F).

Key facts

Active ingredient (INN)
Glyburide
Brand
Sold under the generic name
Strength
5 mg
Dosage form
Tablet
Route
Oral
Packs
100 tablets, 500 tablets, 30 tablets and 80 more
Manufacturers
Zydus LifesciencesIndiaCadila PharmaceuticalsIndiaAvet PharmaceuticalsIndiaNuCare Pharmaceuticals,IncTeva PharmaceuticalsModavar PharmaceuticalsChartwell RX13 labelers on the register
Origin register
US FDA, United States
Storage
Store at 20° to 25°C (68° to 77°F).
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
A10BB01 Glyburide
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
1 May 1984
Identifiers
RxCUI 310537, 197737, 310534DailyMed set ID d090f978-b1a5-4db7-951d-3f32dd06966c, 21786ac0-da3c-16cb-e063-6394a90a4596, 87781ea8-62ec-483c-a4dd-8c965ce59485 +23NDC 50090-6196, 68071-3677, 68382-658 +24Application ANDA203379, ANDA074388, ANDA206749 +2

Record updated 12 November 2026

Documents available

Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.

No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.

Packs

A sample of 40 packs from 13 labelers. The register lists 83 packs for this generic presentation, and we confirm the exact pack on the quote.

PackCodeLabelerMarketed since
100 tablet in 1 bottle65841-834-01Zydus LifesciencesIndia2 June 2016
500 tablet in 1 bottle65841-834-05Zydus LifesciencesIndia2 June 2016
30 tablet in 1 bottle65841-834-06Zydus LifesciencesIndia2 June 2016
1000 tablet in 1 bottle65841-834-10Zydus LifesciencesIndia2 June 2016
90 tablet in 1 bottle65841-834-16Zydus LifesciencesIndia2 June 2016
10 blister pack in 1 carton / 10 tablet in 1 blister pack65841-834-77Zydus LifesciencesIndia2 June 2016
100 tablet in 1 bottle68382-658-01Zydus LifesciencesIndia2 June 2016
500 tablet in 1 bottle68382-658-05Zydus LifesciencesIndia2 June 2016
30 tablet in 1 bottle68382-658-06Zydus LifesciencesIndia2 June 2016
1000 tablet in 1 bottle68382-658-10Zydus LifesciencesIndia2 June 2016
90 tablet in 1 bottle68382-658-16Zydus LifesciencesIndia2 June 2016
10 blister pack in 1 carton / 10 tablet in 1 blister pack68382-658-77Zydus LifesciencesIndia2 June 2016
100 tablet in 1 bottle23155-058-01Avet PharmaceuticalsIndia5 October 2010
1000 tablet in 1 bottle23155-058-10Avet PharmaceuticalsIndia5 October 2010
100 tablet in 1 bottle71209-011-05Cadila PharmaceuticalsIndia26 April 2014
500 tablet in 1 bottle71209-011-10Cadila PharmaceuticalsIndia20 August 2019
1000 tablet in 1 bottle71209-011-11Cadila PharmaceuticalsIndia26 April 2014
100 tablet in 1 bottle0093-8344-01Teva Pharmaceuticals30 August 1995
500 tablet in 1 bottle0093-8344-05Teva Pharmaceuticals30 August 1995
1000 tablet in 1 bottle0093-8344-10Teva Pharmaceuticals30 August 1995
90 tablet in 1 bottle0093-8344-98Teva Pharmaceuticals30 March 2010
100 tablet in 1 bottle0093-9364-01TEVA Pharmaceuticals1 May 1984
500 tablet in 1 bottle0093-9364-05TEVA Pharmaceuticals1 May 1984
1000 tablet in 1 bottle0093-9364-10TEVA Pharmaceuticals1 May 1984
90 tablet in 1 bottle62135-585-90Chartwell RX9 May 2023
100 tablet in 1 bottle72241-040-05Modavar Pharmaceuticals5 October 2021
500 tablet in 1 bottle72241-040-10Modavar Pharmaceuticals5 October 2021
1000 tablet in 1 bottle72241-040-11Modavar Pharmaceuticals5 October 2021
30 tablet in 1 bottle66267-103-30NuCare Pharmaceuticals6 October 2016
60 tablet in 1 bottle66267-103-60NuCare Pharmaceuticals6 October 2016
90 tablet in 1 bottle66267-103-90NuCare Pharmaceuticals6 October 2016
120 tablet in 1 bottle66267-103-91NuCare Pharmaceuticals6 October 2016
30 tablet in 1 bottle68071-3452-3NuCare Pharmaceuticals,Inc6 July 2023
60 tablet in 1 bottle68071-3452-6NuCare Pharmaceuticals,Inc16 January 2026
100 tablet in 1 bottle68071-3677-0NuCare Pharmaceuticals6 September 2024
60 tablet in 1 bottle68071-3702-6NuCare Pharmaceuticals25 October 2024
30 tablet in 1 bottle68071-4695-3NuCare Pharmaceuticals,Inc7 January 2019
60 tablet in 1 bottle68071-4695-6NuCare Pharmaceuticals,Inc7 January 2019
90 tablet in 1 bottle68071-4695-9NuCare Pharmaceuticals,Inc7 January 2019
100 tablet in 1 bottle68071-5030-0NuCare Pharmaceuticals,Inc14 August 2019

Status by register

Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 1 May 1984Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Import route

Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.

Import guides are available for 25 countries. Pick one to see its route summary.

BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides

Other strengths and forms of Glyburide

Clinical summary

Glyburide is a sulfonylurea indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It is available as tablets for oral use. MedsAcross supplies Glyburide for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Read about Glyburide

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Glyburide 5 mg tablet for your hospital or patient?

Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.