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Medicine

Telmisartan 80 mg tablet

Telmisartan · Oral
Available on requestPrescription onlyUS FDAGeneric name

Telmisartan 80 mg tablet is a generic prescription medicine for oral use, made by 23 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), excursions permitted between 15° to 30°C…

Key facts

Active ingredient (INN)
Telmisartan
Brand
Sold under the generic name
Strength
80 mg
Dosage form
Tablet
Route
Oral
Packs
30 tablets, 1000 tablets, 100 tablets and 78 more
Manufacturers
Zydus LifesciencesIndiaCadila PharmaceuticalsIndiaGlenmark PharmaceuticalsIndiaAlembic PharmaceuticalsIndiaAscend LaboratoriesIndiaAurobindo PharmaIndiaLifestar PharmaIndiaMacleods PharmaceuticalsIndiaJubilant Cadista PharmaceuticalsIndiaAmneal Pharmaceuticals23 labelers on the register
Origin register
US FDA, United States
Storage
Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C (59° to 86°F).
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
C09CA07 Telmisartan
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
31 May 2013
Identifiers
RxCUI 205304, 205305, 282755DailyMed set ID bf2dca37-ce9c-40e4-8ad6-b8186aa7fed1, e1a907a7-fad9-a860-8639-4c6136c85734, 3f021f06-99df-48d1-e063-6394a90a8d0f +28NDC 53746-293, 59746-441, 68071-3892 +28Application ANDA204415, ANDA204164, ANDA207882 +10

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 23 labelers. The register lists 81 packs for this generic presentation, and we confirm the exact pack on the quote.

PackCodeLabelerMarketed since
30 tablet in 1 bottle46708-610-30Alembic PharmaceuticalsIndia25 June 2016
1000 tablet in 1 bottle46708-610-91Alembic PharmaceuticalsIndia25 June 2016
30 tablet in 1 bottle62332-089-30Alembic PharmaceuticalsIndia25 June 2016
1000 tablet in 1 bottle62332-089-91Alembic PharmaceuticalsIndia25 June 2016
100 tablet in 1 bottle65841-806-01Zydus LifesciencesIndia27 August 2014
500 tablet in 1 bottle65841-806-05Zydus LifesciencesIndia27 August 2014
30 tablet in 1 bottle65841-806-06Zydus LifesciencesIndia27 August 2014
1000 tablet in 1 bottle65841-806-10Zydus LifesciencesIndia27 August 2014
90 tablet in 1 bottle65841-806-16Zydus LifesciencesIndia27 August 2014
30 blister pack in 1 carton / 1 tablet in 1 blister pack65841-806-78Zydus LifesciencesIndia27 August 2014
100 tablet in 1 bottle68382-473-01Zydus LifesciencesIndia27 August 2014
500 tablet in 1 bottle68382-473-05Zydus LifesciencesIndia27 August 2014
30 tablet in 1 bottle68382-473-06Zydus LifesciencesIndia27 August 2014
1000 tablet in 1 bottle68382-473-10Zydus LifesciencesIndia27 August 2014
90 tablet in 1 bottle68382-473-16Zydus LifesciencesIndia27 August 2014
30 blister pack in 1 carton / 1 tablet in 1 blister pack68382-473-78Zydus LifesciencesIndia27 August 2014
500 tablet in 1 bottle67877-484-05Ascend LaboratoriesIndia25 July 2019
30 tablet in 1 bottle67877-484-30Ascend LaboratoriesIndia25 July 2019
90 tablet in 1 bottle67877-484-90Ascend LaboratoriesIndia25 July 2019
3 blister pack in 1 carton / 10 tablet in 1 blister pack65862-869-03Aurobindo PharmaIndia3 September 2015
30 tablet in 1 bottle65862-869-30Aurobindo PharmaIndia3 June 2019
30 tablet in 1 bottle71209-051-01Cadila PharmaceuticalsIndia22 December 2022
90 tablet in 1 bottle71209-051-04Cadila PharmaceuticalsIndia22 December 2022
100 tablet in 1 bottle71209-051-05Cadila PharmaceuticalsIndia22 December 2022
500 tablet in 1 bottle71209-051-10Cadila PharmaceuticalsIndia22 December 2022
1000 tablet in 1 bottle71209-051-11Cadila PharmaceuticalsIndia22 December 2022
30 blister pack in 1 carton / 10 tablet in 1 blister pack71209-051-16Cadila PharmaceuticalsIndia5 February 2015
30 blister pack in 1 carton / 10 tablet in 1 blister pack71209-051-18Cadila PharmaceuticalsIndia5 February 2015
100 tablet in 1 bottle68462-201-01Glenmark PharmaceuticalsIndia7 July 2014
3 blister pack in 1 carton / 10 tablet in 1 blister pack68462-201-13Glenmark PharmaceuticalsIndia7 July 2014
30 tablet in 1 bottle68462-201-30Glenmark PharmaceuticalsIndia14 December 2020
4 blister pack in 1 carton / 10 tablet in 1 blister pack68462-201-78Glenmark PharmaceuticalsIndia14 December 2020
90 tablet in 1 bottle68462-201-90Glenmark PharmaceuticalsIndia7 March 2024
3 blister pack in 1 carton / 10 tablet in 1 blister pack59746-441-32Jubilant Cadista PharmacuticalsIndia22 August 2016
30 tablet in 1 bottle70756-314-30Lifestar PharmaIndia15 October 2024
8 blister pack in 1 carton / 10 tablet in 1 blister pack70756-314-80Lifestar PharmaIndia15 October 2024
30 tablet in 1 container33342-120-07Macleods PharmaceuticalsIndia15 January 2025
90 tablet in 1 container33342-120-10Macleods PharmaceuticalsIndia15 January 2025
30 tablet in 1 bottle65162-293-03Amneal Pharmaceuticals31 May 2013
90 tablet in 1 bottle65162-293-09Amneal Pharmaceuticals31 May 2013

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 10 November 1998Drugs@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 Telmisartan

Clinical summary

Telmisartan is an angiotensin 2 receptor blocker indicated for treatment of hypertension to lower blood pressure. It is available as tablets for oral use. MedsAcross supplies Telmisartan 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 Telmisartan

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

Data sources

Need Telmisartan 80 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.