Medicine
Hydrochlorothiazide and Irbesartan 25 mg/300 mg tablet
Hydrochlorothiazide and Irbesartan 25 mg/300 mg tablet is a generic prescription medicine for oral use, made by 2 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 20ºC to 25ºC (68ºF to 77ºF).
Key facts
- Active ingredient (INN)
- Hydrochlorothiazide and Irbesartan
- Brand
- Sold under the generic name
- Strength
- 25 mg/300 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 10 tablets, 30 tablets, 90 tablets and 9 more
- Manufacturers
- Alembic PharmaceuticalsIndiaAurobindo PharmaIndia
- Origin register
- US FDA, United States
- Storage
- Store at 20ºC to 25ºC (68ºF to 77ºF).
- 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
- 31 March 2016
- Identifiers
- RxCUI 310792, 310793, 485471DailyMed set ID 466dd0d2-9815-4c3e-b66b-d0732b3ba8e9, 9492a1cd-c012-4b43-931d-235220065e1e, e842fa14-b18e-4463-9bf1-a1c8700fe33cNDC 65862-631, 46708-444, 62332-053Application ANDA203630, ANDA091370
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 | 46708-444-10 | Alembic PharmaceuticalsIndia | 23 May 2016 |
| 30 tablet in 1 bottle | 46708-444-30 | Alembic PharmaceuticalsIndia | 23 May 2016 |
| 90 tablet in 1 bottle | 46708-444-90 | Alembic PharmaceuticalsIndia | 23 May 2016 |
| 1000 tablet in 1 bottle | 46708-444-91 | Alembic PharmaceuticalsIndia | 23 May 2016 |
| 10 tablet, film coated in 1 blister pack | 62332-053-10 | Alembic PharmaceuticalsIndia | 23 May 2016 |
| 30 tablet, film coated in 1 bottle | 62332-053-30 | Alembic PharmaceuticalsIndia | 23 May 2016 |
| 90 tablet, film coated in 1 bottle | 62332-053-90 | Alembic PharmaceuticalsIndia | 23 May 2016 |
| 1000 tablet, film coated in 1 bottle | 62332-053-91 | Alembic PharmaceuticalsIndia | 23 May 2016 |
| 500 tablet, film coated in 1 bottle | 65862-631-05 | Aurobindo PharmaIndia | 31 March 2016 |
| 30 tablet, film coated in 1 bottle | 65862-631-30 | Aurobindo PharmaIndia | 31 March 2016 |
| 90 tablet, film coated in 1 bottle | 65862-631-90 | Aurobindo PharmaIndia | 31 March 2016 |
| 1000 tablet, film coated in 1 bottle | 65862-631-99 | Aurobindo PharmaIndia | 31 March 2016 |
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 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 25 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.