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Medicine

Hydrochlorothiazide and Telmisartan 12.5 mg/80 mg tablet

Available on requestPrescription onlyUS FDAGeneric name

Hydrochlorothiazide and Telmisartan 12.5 mg/80 mg tablet is a generic prescription medicine for oral use, made by 7 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 to 15 to 30°C (59 to…

Key facts

Active ingredient (INN)
Hydrochlorothiazide and Telmisartan
Brand
Sold under the generic name
Strength
12.5 mg/80 mg
Dosage form
Tablet
Route
Oral
Packs
100 tablets, 30 tablets, 1000 tablets and 11 more
Manufacturers
Alembic PharmaceuticalsIndiaLifestar PharmaIndiaAurobindo PharmaIndiaGlenmark PharmaceuticalsIndiaSolco HealthcareAvKARE7 labelers on the register
Origin register
US FDA, United States
Storage
Store at 20° to 25°C (68° to 77°F), excursions permitted to 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
C09DA07 Hydrochlorothiazide and Telmisartan
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
7 August 2014
Identifiers
RxCUI 283316, 283317, 477130DailyMed set ID e80f232c-c1c4-4524-a0a5-d23ee0d1f3b7, 1e55800d-f77c-4950-a6d7-2055f4c7ea17, 0c1bd0f4-034e-486c-ae46-2855c8c9ebda +5NDC 62332-210, 68462-841, 70756-316 +5Application ANDA203010, ANDA202544, ANDA218406 +3

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

Packs from every labeler of this generic presentation.

PackCodeLabelerMarketed since
100 tablet in 1 carton46708-210-10Alembic PharmaceuticalsIndia25 June 2016
30 tablet in 1 bottle46708-210-30Alembic PharmaceuticalsIndia25 June 2016
1000 tablet in 1 bottle46708-210-91Alembic PharmaceuticalsIndia25 June 2016
100 tablet in 1 carton62332-210-10Alembic PharmaceuticalsIndia25 June 2016
30 tablet in 1 bottle62332-210-30Alembic PharmaceuticalsIndia25 June 2016
1000 tablet in 1 bottle62332-210-91Alembic PharmaceuticalsIndia25 June 2016
3 blister pack in 1 carton / 10 tablet in 1 blister pack65862-977-03Aurobindo PharmaIndia15 December 2016
3 blister pack in 1 carton / 10 tablet in 1 blister pack68462-841-13Glenmark PharmaceuticalsIndia4 March 2019
30 tablet in 1 bottle70756-316-30Lifestar PharmaIndia25 December 2025
3 blister pack in 1 carton / 10 tablet in 1 blister pack70756-316-31Lifestar PharmaIndia25 December 2025
10 blister pack in 1 carton / 10 tablet in 1 blister pack70756-316-99Lifestar PharmaIndia25 December 2025
30 tablet in 1 bottle43547-442-03Solco Healthcare5 February 2018
90 tablet in 1 bottle43547-442-09Solco Healthcare5 February 2018
3 blister pack in 1 box / 10 tablet in 1 blister pack42291-463-30AvKARE18 June 2024

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 17 November 2000Drugs@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

Alternatives

Other makers and brands of Hydrochlorothiazide and Telmisartan 12.5 mg/80 mg tablet.

Compare 1

Other strengths and forms of Hydrochlorothiazide and Telmisartan

Clinical summary

Hydrochlorothiazide and Telmisartan is a fixed-dose combination of an angiotensin 2 receptor blocker and a thiazide diuretic indicated for the treatment of hypertension, to lower blood pressure, among other approved uses. MedsAcross supplies Hydrochlorothiazide and 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 Hydrochlorothiazide and Telmisartan

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

Data sources

Need Hydrochlorothiazide and Telmisartan 12.5 mg/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.