Medicine
Hydrochlorothiazide and Irbesartan 12.5 mg/300 mg tablet
Hydrochlorothiazide and Irbesartan 12.5 mg/300 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
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/300 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 10 tablets, 30 tablets, 90 tablets and 24 more
- Manufacturers
- Alembic PharmaceuticalsIndiaMacleods PharmaceuticalsIndiaAurobindo PharmaIndiaUnichem LaboratoriesIndiaSolco HealthcareRemedyrepackTeva Pharmaceuticals
- 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 72fa8cd4-bc2a-4a7d-8feb-2d60e077d801, 83f4acc1-697a-4770-b554-1b9a8fb5de74, 181324c5-256f-4570-a0bb-8bc908deb2e2 +5NDC 43547-331, 0093-8232, 29300-216 +5Application ANDA203072, ANDA077369, ANDA207018 +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.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 10 tablet in 1 blister pack | 46708-443-10 | Alembic PharmaceuticalsIndia | 23 May 2016 |
| 30 tablet in 1 bottle | 46708-443-30 | Alembic PharmaceuticalsIndia | 23 May 2016 |
| 90 tablet in 1 bottle | 46708-443-90 | Alembic PharmaceuticalsIndia | 23 May 2016 |
| 1000 tablet in 1 bottle | 46708-443-91 | Alembic PharmaceuticalsIndia | 23 May 2016 |
| 10 tablet in 1 blister pack | 62332-052-10 | Alembic PharmaceuticalsIndia | 23 May 2016 |
| 30 tablet in 1 bottle | 62332-052-30 | Alembic PharmaceuticalsIndia | 23 May 2016 |
| 90 tablet in 1 bottle | 62332-052-90 | Alembic PharmaceuticalsIndia | 23 May 2016 |
| 1000 tablet in 1 bottle | 62332-052-91 | Alembic PharmaceuticalsIndia | 23 May 2016 |
| 500 tablet, film coated in 1 bottle | 65862-630-05 | Aurobindo PharmaIndia | 22 February 2013 |
| 30 tablet, film coated in 1 bottle | 65862-630-30 | Aurobindo PharmaIndia | 22 February 2013 |
| 90 tablet, film coated in 1 bottle | 65862-630-90 | Aurobindo PharmaIndia | 22 February 2013 |
| 1000 tablet, film coated in 1 bottle | 65862-630-99 | Aurobindo PharmaIndia | 22 February 2013 |
| 3 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 33342-058-06 | Macleods PharmaceuticalsIndia | 27 September 2012 |
| 30 tablet, film coated in 1 bottle | 33342-058-07 | Macleods PharmaceuticalsIndia | 27 September 2012 |
| 90 tablet, film coated in 1 bottle | 33342-058-10 | Macleods PharmaceuticalsIndia | 27 September 2012 |
| 500 tablet, film coated in 1 bottle | 33342-058-15 | Macleods PharmaceuticalsIndia | 27 September 2012 |
| 9 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 33342-058-39 | Macleods PharmaceuticalsIndia | 27 September 2012 |
| 1000 tablet, film coated in 1 bottle, plastic | 29300-216-10 | Unichem LaboratoriesIndia | 31 March 2018 |
| 30 tablet, film coated in 1 bottle, plastic | 29300-216-13 | Unichem LaboratoriesIndia | 31 March 2018 |
| 90 tablet, film coated in 1 bottle, plastic | 29300-216-19 | Unichem LaboratoriesIndia | 31 March 2018 |
| 30 tablet in 1 bottle | 43547-331-03 | Solco Healthcare | 1 March 2014 |
| 90 tablet in 1 bottle | 43547-331-09 | Solco Healthcare | 1 March 2014 |
| 500 tablet in 1 bottle | 43547-331-50 | Solco Healthcare | 1 March 2014 |
| 30 tablet, film coated in 1 bottle | 0093-8232-56 | Teva Pharmaceuticals | 27 August 2013 |
| 90 tablet, film coated in 1 bottle | 0093-8232-98 | Teva Pharmaceuticals | 27 August 2013 |
| 90 tablet in 1 bottle, plastic | 70518-1550-0 | Remedyrepack | 18 October 2018 |
| 90 tablet in 1 bottle, plastic | 70518-1550-1 | Remedyrepack | 27 August 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
Alternatives
Other makers and brands of Hydrochlorothiazide and Irbesartan 12.5 mg/300 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/300 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.