Medicine
Irbesartan 75 mg tablet
Irbesartan 75 mg tablet is a generic prescription medicine for oral use, made by 19 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
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)
- Irbesartan
- Brand
- Sold under the generic name
- Strength
- 75 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 30 tablets, 100 tablets, 500 tablets and 59 more
- Manufacturers
- Alembic PharmaceuticalsIndiaCamber PharmaceuticalsIndiaMacleods PharmaceuticalsIndiaNovadoz PharmaceuticalsIndiaAurobindo PharmaIndiaJubilant Cadista PharmaceuticalsIndiaUnichem LaboratoriesIndiaAmneal PharmaceuticalsChartwell RX19 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
- 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 2113a901-2612-4557-b86d-3afc006fb8bb, 9b8581c1-d052-4fe2-a9fc-cf7adf0f9061, 61ab1b6e-c849-49ca-a3f0-150774db649d +20NDC 65862-637, 83008-085, 42658-121 +20Application ANDA203081, ANDA202910, ANDA206194 +9
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 19 labelers. The register lists 62 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 30 tablet in 1 bottle | 46708-439-30 | Alembic PharmaceuticalsIndia | 1 July 2016 |
| 100 tablet in 1 bottle | 46708-439-31 | Alembic PharmaceuticalsIndia | 1 July 2016 |
| 500 tablet in 1 bottle | 46708-439-71 | Alembic PharmaceuticalsIndia | 1 July 2016 |
| 90 tablet in 1 bottle | 46708-439-90 | Alembic PharmaceuticalsIndia | 1 July 2016 |
| 1000 tablet in 1 bottle | 46708-439-91 | Alembic PharmaceuticalsIndia | 1 July 2016 |
| 30 tablet in 1 bottle | 62332-041-30 | Alembic PharmaceuticalsIndia | 1 July 2016 |
| 100 tablet in 1 bottle | 62332-041-31 | Alembic PharmaceuticalsIndia | 1 July 2016 |
| 500 tablet in 1 bottle | 62332-041-71 | Alembic PharmaceuticalsIndia | 1 July 2016 |
| 90 tablet in 1 bottle | 62332-041-90 | Alembic PharmaceuticalsIndia | 1 July 2016 |
| 1000 tablet in 1 bottle | 62332-041-91 | Alembic PharmaceuticalsIndia | 1 July 2016 |
| 500 tablet in 1 bottle | 31722-160-05 | Camber PharmaceuticalsIndia | 6 October 2016 |
| 500 tablet in 1 bottle | 31722-729-05 | Camber PharmaceuticalsIndia | 27 September 2012 |
| 1000 tablet in 1 bottle | 31722-729-10 | Camber PharmaceuticalsIndia | 6 March 2025 |
| 30 tablet in 1 bottle | 31722-729-30 | Camber PharmaceuticalsIndia | 27 September 2012 |
| 120 blister pack in 1 carton / 10 tablet in 1 blister pack | 31722-729-31 | Camber PharmaceuticalsIndia | 27 September 2012 |
| 90 tablet in 1 bottle | 31722-729-90 | Camber PharmaceuticalsIndia | 27 September 2012 |
| 500 tablet in 1 bottle | 65862-637-05 | Aurobindo PharmaIndia | 27 September 2012 |
| 30 tablet in 1 bottle | 65862-637-30 | Aurobindo PharmaIndia | 27 September 2012 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 65862-637-78 | Aurobindo PharmaIndia | 22 September 2014 |
| 90 tablet in 1 bottle | 65862-637-90 | Aurobindo PharmaIndia | 27 September 2012 |
| 500 tablet in 1 bottle | 59746-447-05 | Jubilant Cadista PharmaceuticalsIndia | 24 February 2015 |
| 30 tablet in 1 bottle | 59746-447-30 | Jubilant Cadista PharmaceuticalsIndia | 24 February 2015 |
| 90 tablet in 1 bottle | 59746-447-90 | Jubilant Cadista PharmaceuticalsIndia | 24 February 2015 |
| 30 tablet in 1 bottle | 33342-047-07 | Macleods PharmaceuticalsIndia | 27 September 2012 |
| 90 tablet in 1 bottle | 33342-047-10 | Macleods PharmaceuticalsIndia | 11 March 2013 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 33342-047-12 | Macleods PharmaceuticalsIndia | 27 September 2012 |
| 500 tablet in 1 bottle | 33342-047-15 | Macleods PharmaceuticalsIndia | 27 September 2012 |
| 13600 tablet in 1 pouch | 33342-047-68 | Macleods PharmaceuticalsIndia | 26 February 2019 |
| 500 tablet, film coated in 1 bottle | 72205-327-05 | Novadoz PharmaceuticalsIndia | 7 November 2025 |
| 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 72205-327-06 | Novadoz PharmaceuticalsIndia | 7 November 2025 |
| 30 tablet, film coated in 1 bottle | 72205-327-30 | Novadoz PharmaceuticalsIndia | 7 November 2025 |
| 90 tablet, film coated in 1 bottle | 72205-327-90 | Novadoz PharmaceuticalsIndia | 7 November 2025 |
| 1000 tablet, film coated in 1 bottle | 72205-327-99 | Novadoz PharmaceuticalsIndia | 7 November 2025 |
| 500 tablet in 1 bottle, plastic | 29300-212-05 | Unichem LaboratoriesIndia | 28 February 2018 |
| 30 tablet in 1 bottle, plastic | 29300-212-13 | Unichem LaboratoriesIndia | 28 February 2018 |
| 90 tablet in 1 bottle, plastic | 29300-212-19 | Unichem LaboratoriesIndia | 28 February 2018 |
| 30 tablet in 1 bottle | 65162-284-03 | Amneal Pharmaceuticals | 17 April 2018 |
| 90 tablet in 1 bottle | 65162-284-09 | Amneal Pharmaceuticals | 17 April 2018 |
| 500 tablet in 1 bottle | 65162-284-50 | Amneal Pharmaceuticals | 17 April 2018 |
| 30 tablet in 1 bottle | 62135-976-30 | Chartwell RX | 6 May 2025 |
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.
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 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 IrbesartanFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Avapro prescribing information (Sanofi-Aventis) · U.S. National Library of Medicine, DailyMed
- Aprovel: European public assessment report (EPAR) · European Medicines Agency
- Irbesartan Zentiva (previously Irbesartan Winthrop): European public assessment report (EPAR) · European Medicines Agency
Need Irbesartan 75 mg tablet for your hospital or patient?
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