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Medicine

Irbesartan 150 mg tablet

Irbesartan · Oral
Available on requestPrescription onlyUS FDAGeneric name

Irbesartan 150 mg tablet is a generic prescription medicine for oral use, made by 22 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 25°C (77°F), excursions permitted to 15°C to 30°C (59°F to 86°F).

Key facts

Active ingredient (INN)
Irbesartan
Brand
Sold under the generic name
Strength
150 mg
Dosage form
Tablet
Route
Oral
Packs
30 tablets, 100 tablets, 500 tablets and 79 more
Manufacturers
Alembic PharmaceuticalsIndiaCamber PharmaceuticalsIndiaNovadoz PharmaceuticalsIndiaMacleods PharmaceuticalsIndiaAurobindo PharmaIndiaJubilant Cadista PharmaceuticalsIndiaUnichem LaboratoriesIndiaAmneal Pharmaceuticals22 labelers on the register
Origin register
US FDA, United States
Storage
Store at 25°C (77°F), excursions permitted to 15°C to 30°C (59°F to 86°F).
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
C09CA04 Irbesartan
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
27 September 2012
Identifiers
RxCUI 200094, 200095, 200096DailyMed set ID 1f98fd95-e564-45b3-947f-45eba77f2af5, 9b8581c1-d052-4fe2-a9fc-cf7adf0f9061, e8635a1c-ae06-4e23-99f7-e704f91d6f43 +27NDC 72205-328, 83008-084, 33342-048 +28Application ANDA219539, ANDA202910, ANDA202254 +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 22 labelers. The register lists 82 packs for this generic presentation, and we confirm the exact pack on the quote.

PackCodeLabelerMarketed since
30 tablet in 1 bottle46708-440-30Alembic PharmaceuticalsIndia1 July 2016
100 tablet in 1 bottle46708-440-31Alembic PharmaceuticalsIndia1 July 2016
500 tablet in 1 bottle46708-440-71Alembic PharmaceuticalsIndia1 July 2016
90 tablet in 1 bottle46708-440-90Alembic PharmaceuticalsIndia1 July 2016
1000 tablet in 1 bottle46708-440-91Alembic PharmaceuticalsIndia1 July 2016
30 tablet in 1 bottle62332-042-30Alembic PharmaceuticalsIndia1 July 2016
100 tablet in 1 bottle62332-042-31Alembic PharmaceuticalsIndia1 July 2016
500 tablet in 1 bottle62332-042-71Alembic PharmaceuticalsIndia1 July 2016
90 tablet in 1 bottle62332-042-90Alembic PharmaceuticalsIndia1 July 2016
1000 tablet in 1 bottle62332-042-91Alembic PharmaceuticalsIndia1 July 2016
1000 tablet in 1 bottle31722-161-10Camber PharmaceuticalsIndia6 October 2016
500 tablet in 1 bottle31722-730-05Camber PharmaceuticalsIndia27 September 2012
1000 tablet in 1 bottle31722-730-10Camber PharmaceuticalsIndia6 March 2025
30 tablet in 1 bottle31722-730-30Camber PharmaceuticalsIndia27 September 2012
120 blister pack in 1 carton / 10 tablet in 1 blister pack31722-730-31Camber PharmaceuticalsIndia27 September 2012
90 tablet in 1 bottle31722-730-90Camber PharmaceuticalsIndia27 September 2012
500 tablet in 1 bottle65862-638-05Aurobindo PharmaIndia27 September 2012
30 tablet in 1 bottle65862-638-30Aurobindo PharmaIndia27 September 2012
10 blister pack in 1 carton / 10 tablet in 1 blister pack65862-638-78Aurobindo PharmaIndia27 September 2012
90 tablet in 1 bottle65862-638-90Aurobindo PharmaIndia27 September 2012
500 tablet in 1 bottle59746-448-05Jubilant Cadista PharmaceuticalsIndia24 February 2015
30 tablet in 1 bottle59746-448-30Jubilant Cadista PharmaceuticalsIndia24 February 2015
90 tablet in 1 bottle59746-448-90Jubilant Cadista PharmaceuticalsIndia24 February 2015
30 tablet in 1 bottle33342-048-07Macleods PharmaceuticalsIndia27 September 2012
90 tablet in 1 bottle33342-048-10Macleods PharmaceuticalsIndia11 March 2013
10 blister pack in 1 carton / 10 tablet in 1 blister pack33342-048-12Macleods PharmaceuticalsIndia27 September 2012
500 tablet in 1 bottle33342-048-15Macleods PharmaceuticalsIndia27 September 2012
6800 tablet in 1 pouch33342-048-65Macleods PharmaceuticalsIndia26 February 2019
500 tablet, film coated in 1 bottle72205-328-05Novadoz PharmaceuticalsIndia7 November 2025
10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack72205-328-06Novadoz PharmaceuticalsIndia7 November 2025
10 tablet, film coated in 1 bottle72205-328-10Novadoz PharmaceuticalsIndia7 November 2025
30 tablet, film coated in 1 bottle72205-328-30Novadoz PharmaceuticalsIndia7 November 2025
90 tablet, film coated in 1 bottle72205-328-90Novadoz PharmaceuticalsIndia7 November 2025
1000 tablet, film coated in 1 bottle72205-328-99Novadoz PharmaceuticalsIndia7 November 2025
500 tablet in 1 bottle, plastic29300-213-05Unichem LaboratoriesIndia28 February 2018
30 tablet in 1 bottle, plastic29300-213-13Unichem LaboratoriesIndia28 February 2018
90 tablet in 1 bottle, plastic29300-213-19Unichem LaboratoriesIndia28 February 2018
30 tablet in 1 bottle65162-285-03Amneal Pharmaceuticals17 April 2018
90 tablet in 1 bottle65162-285-09Amneal Pharmaceuticals17 April 2018
1000 tablet in 1 bottle65162-285-11Amneal Pharmaceuticals17 April 2018

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 30 September 1997Drugs@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 Irbesartan 150 mg tablet.

Compare 1

Other strengths and forms of Irbesartan

Clinical summary

Irbesartan is an angiotensin 2 receptor blocker indicated for treatment of hypertension, to lower blood pressure, among other approved uses. It is available as tablets for oral use. MedsAcross supplies Irbesartan 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 Irbesartan

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

Data sources

Need Irbesartan 150 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.