Medicine
Hydrochlorothiazide and Irbesartan 12.5 mg/150 mg tablet
Hydrochlorothiazide and Irbesartan 12.5 mg/150 mg tablet is a generic prescription medicine for oral use, made by 8 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°C-25°C (68°F-77°F), excursions permitted to 15°C-30°C (59°F-86°F).
Key facts
- Active ingredient (INN)
- Hydrochlorothiazide and Irbesartan
- Brand
- Sold under the generic name
- Strength
- 12.5 mg/150 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 10 tablets, 30 tablets, 90 tablets and 46 more
- Manufacturers
- Alembic PharmaceuticalsIndiaMacleods PharmaceuticalsIndiaAurobindo PharmaIndiaUnichem LaboratoriesIndiaBryant Ranch PrepackSolco HealthcareTeva Pharmaceuticals8 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20°C-25°C (68°F-77°F), excursions permitted to 15°C-30°C (59°F-86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C09DA04 Hydrochlorothiazide and 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 310792, 310793, 485471DailyMed set ID 85494404-484c-45a1-8487-f9eb2a76490d, 5029c9f7-6233-4a6f-ace9-2268cc8e286d, 46d77ed8-ece2-4f51-b1a4-4a440e2dce2d +13NDC 71335-2099, 72162-1035, 63629-7468 +13Application ANDA203072, ANDA077369, ANDA202414 +4
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 8 labelers. The register lists 49 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 10 tablet in 1 blister pack | 46708-442-10 | Alembic PharmaceuticalsIndia | 23 May 2016 |
| 30 tablet in 1 bottle | 46708-442-30 | Alembic PharmaceuticalsIndia | 23 May 2016 |
| 90 tablet in 1 bottle | 46708-442-90 | Alembic PharmaceuticalsIndia | 23 May 2016 |
| 1000 tablet in 1 bottle | 46708-442-91 | Alembic PharmaceuticalsIndia | 23 May 2016 |
| 10 tablet in 1 blister pack | 62332-051-10 | Alembic PharmaceuticalsIndia | 23 May 2016 |
| 30 tablet in 1 bottle | 62332-051-30 | Alembic PharmaceuticalsIndia | 23 May 2016 |
| 90 tablet in 1 bottle | 62332-051-90 | Alembic PharmaceuticalsIndia | 23 May 2016 |
| 1000 tablet in 1 bottle | 62332-051-91 | Alembic PharmaceuticalsIndia | 23 May 2016 |
| 500 tablet, film coated in 1 bottle | 65862-629-05 | Aurobindo PharmaIndia | 22 February 2013 |
| 30 tablet, film coated in 1 bottle | 65862-629-30 | Aurobindo PharmaIndia | 22 February 2013 |
| 90 tablet, film coated in 1 bottle | 65862-629-90 | Aurobindo PharmaIndia | 22 February 2013 |
| 1000 tablet, film coated in 1 bottle | 65862-629-99 | Aurobindo PharmaIndia | 22 February 2013 |
| 3 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 33342-057-06 | Macleods PharmaceuticalsIndia | 27 September 2012 |
| 30 tablet, film coated in 1 bottle | 33342-057-07 | Macleods PharmaceuticalsIndia | 27 September 2012 |
| 90 tablet, film coated in 1 bottle | 33342-057-10 | Macleods PharmaceuticalsIndia | 27 September 2012 |
| 500 tablet, film coated in 1 bottle | 33342-057-15 | Macleods PharmaceuticalsIndia | 27 September 2012 |
| 9 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 33342-057-39 | Macleods PharmaceuticalsIndia | 27 September 2012 |
| 1000 tablet, film coated in 1 bottle, plastic | 29300-215-10 | Unichem LaboratoriesIndia | 31 March 2018 |
| 30 tablet, film coated in 1 bottle, plastic | 29300-215-13 | Unichem LaboratoriesIndia | 31 March 2018 |
| 90 tablet, film coated in 1 bottle, plastic | 29300-215-19 | Unichem LaboratoriesIndia | 31 March 2018 |
| 30 tablet in 1 bottle | 43547-330-03 | Solco Healthcare | 1 March 2014 |
| 90 tablet in 1 bottle | 43547-330-09 | Solco Healthcare | 1 March 2014 |
| 500 tablet in 1 bottle | 43547-330-50 | Solco Healthcare | 1 March 2014 |
| 30 tablet, film coated in 1 bottle | 0093-8238-56 | Teva Pharmaceuticals | 24 January 2013 |
| 90 tablet, film coated in 1 bottle | 0093-8238-98 | Teva Pharmaceuticals | 20 February 2013 |
| 30 tablet, film coated in 1 bottle | 63629-7468-1 | Bryant Ranch Prepack | 12 February 2019 |
| 90 tablet, film coated in 1 bottle | 63629-7468-2 | Bryant Ranch Prepack | 20 November 2017 |
| 28 tablet, film coated in 1 bottle | 63629-7468-3 | Bryant Ranch Prepack | 2 September 2022 |
| 30 tablet, film coated in 1 bottle | 71335-1097-1 | Bryant Ranch Prepack | 12 February 2019 |
| 90 tablet, film coated in 1 bottle | 71335-1097-2 | Bryant Ranch Prepack | 17 March 2021 |
| 28 tablet, film coated in 1 bottle | 71335-1097-3 | Bryant Ranch Prepack | 8 April 2022 |
| 30 tablet in 1 bottle | 71335-1787-1 | Bryant Ranch Prepack | 12 August 2021 |
| 90 tablet in 1 bottle | 71335-1787-2 | Bryant Ranch Prepack | 20 December 2021 |
| 28 tablet in 1 bottle | 71335-1787-3 | Bryant Ranch Prepack | 20 December 2021 |
| 30 tablet in 1 bottle | 71335-2099-1 | Bryant Ranch Prepack | 6 June 2022 |
| 90 tablet in 1 bottle | 71335-2099-2 | Bryant Ranch Prepack | 6 June 2022 |
| 28 tablet in 1 bottle | 71335-2099-3 | Bryant Ranch Prepack | 6 June 2022 |
| 90 tablet, film coated in 1 bottle | 72162-1035-9 | Bryant Ranch Prepack | 7 April 2026 |
| 30 tablet in 1 bottle | 72162-2317-3 | Bryant Ranch Prepack | 1 March 2014 |
| 90 tablet in 1 bottle | 72162-2317-9 | Bryant Ranch Prepack | 1 March 2014 |
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
Alternatives
Other makers and brands of Hydrochlorothiazide and Irbesartan 12.5 mg/150 mg tablet.
Other strengths and forms of Hydrochlorothiazide and Irbesartan
Clinical summary
Hydrochlorothiazide and Irbesartan is a fixed-dose combination of an angiotensin 2 receptor blocker and a thiazide diuretic indicated for the treatment of hypertension. It is available as tablets for oral use. MedsAcross supplies Hydrochlorothiazide and 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 Hydrochlorothiazide and 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
- Avalide prescribing information (Sanofi-Aventis) · U.S. National Library of Medicine, DailyMed
- CoAprovel: European public assessment report (EPAR) · European Medicines Agency
- Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop): European public assessment report (EPAR) · European Medicines Agency
Need Hydrochlorothiazide and Irbesartan 12.5 mg/150 mg tablet for your hospital or patient?
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