Medicine
Hydrochlorothiazide and Valsartan 12.5 mg/80 mg tablet
Hydrochlorothiazide and Valsartan 12.5 mg/80 mg tablet is a generic prescription medicine for oral use, made by 15 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 between 15°C and 30°C…
Key facts
- Active ingredient (INN)
- Hydrochlorothiazide and Valsartan
- Brand
- Sold under the generic name
- Strength
- 12.5 mg/80 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 30 tablets, 500 tablets and 42 more
- Manufacturers
- Alembic PharmaceuticalsIndiaAurobindo PharmaIndiaZydus LifesciencesIndiaMacleods PharmaceuticalsIndiaProficient RxAmneal PharmaceuticalsSolco HealthcareScieGen PharmaceuticalsA-S Medication SolutionsAmneal Pharmaceuticals of New York15 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20°C-25°C (68°F-77°F), excursions permitted between 15°C and 30°C (59°F and 86°F). Protect from moisture.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 21 September 2012
- Identifiers
- RxCUI 200284, 200285, 349353 +2DailyMed set ID d74a85de-5917-401a-b92d-6a95da5d30a6, f8b0a8ab-4549-4553-a127-bf2c0291a4b1, 17362ff8-07bb-42c6-a100-8adb93be0348 +17NDC 68180-103, 43547-311, 50228-147 +17Application ANDA078946, ANDA206083, ANDA204687 +6
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 15 labelers. The register lists 45 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet, film coated in 1 carton | 46708-453-10 | Alembic PharmaceuticalsIndia | 20 May 2016 |
| 30 tablet, film coated in 1 bottle | 46708-453-30 | Alembic PharmaceuticalsIndia | 20 May 2016 |
| 500 tablet, film coated in 1 bottle | 46708-453-71 | Alembic PharmaceuticalsIndia | 20 May 2016 |
| 90 tablet, film coated in 1 bottle | 46708-453-90 | Alembic PharmaceuticalsIndia | 20 May 2016 |
| 100 tablet, film coated in 1 carton | 62332-079-10 | Alembic PharmaceuticalsIndia | 20 May 2016 |
| 30 tablet, film coated in 1 bottle | 62332-079-30 | Alembic PharmaceuticalsIndia | 20 May 2016 |
| 500 tablet, film coated in 1 bottle | 62332-079-71 | Alembic PharmaceuticalsIndia | 20 May 2016 |
| 90 tablet, film coated in 1 bottle | 62332-079-90 | Alembic PharmaceuticalsIndia | 20 May 2016 |
| 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 65862-547-10 | Aurobindo PharmaIndia | 21 March 2013 |
| 90 tablet, film coated in 1 bottle | 65862-547-90 | Aurobindo PharmaIndia | 21 March 2013 |
| 1000 tablet, film coated in 1 bottle | 65862-547-99 | Aurobindo PharmaIndia | 21 March 2013 |
| 90 tablet, film coated in 1 bottle | 33342-074-10 | Macleods PharmaceuticalsIndia | 19 April 2013 |
| 1000 tablet, film coated in 1 bottle | 33342-074-44 | Macleods PharmaceuticalsIndia | 19 April 2013 |
| 1000 tablet, film coated in 1 bottle | 70771-1485-0 | Zydus LifesciencesIndia | 12 February 2020 |
| 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 70771-1485-4 | Zydus LifesciencesIndia | 12 February 2020 |
| 90 tablet, film coated in 1 bottle | 70771-1485-9 | Zydus LifesciencesIndia | 12 February 2020 |
| 30 tablet, film coated in 1 bottle | 65162-845-03 | Amneal Pharmaceuticals | 14 August 2023 |
| 90 tablet, film coated in 1 bottle | 65162-845-09 | Amneal Pharmaceuticals | 14 August 2023 |
| 1000 tablet, film coated in 1 bottle | 65162-845-11 | Amneal Pharmaceuticals | 14 August 2023 |
| 500 tablet, film coated in 1 bottle | 65162-845-50 | Amneal Pharmaceuticals | 14 August 2023 |
| 90 tablet, film coated in 1 bottle | 53746-845-90 | Amneal Pharmaceuticals of New York | 14 August 2023 |
| 90 tablet, film coated in 1 bottle, plastic | 0378-6321-77 | Mylan Pharmaceuticals | 21 September 2012 |
| 1000 tablet, film coated in 1 bottle | 50228-147-10 | ScieGen Pharmaceuticals | 27 July 2026 |
| 30 tablet, film coated in 1 bottle | 50228-147-30 | ScieGen Pharmaceuticals | 27 July 2026 |
| 30 tablet, film coated in 1 bottle | 43547-311-03 | Solco Healthcare | 3 December 2021 |
| 90 tablet, film coated in 1 bottle | 43547-311-09 | Solco Healthcare | 3 December 2021 |
| 500 tablet, film coated in 1 bottle | 43547-311-50 | Solco Healthcare | 3 December 2021 |
| 30 tablet, film coated in 1 bottle | 63187-571-30 | Proficient Rx | 1 December 2018 |
| 60 tablet, film coated in 1 bottle | 63187-571-60 | Proficient Rx | 1 December 2018 |
| 90 tablet, film coated in 1 bottle | 63187-571-90 | Proficient Rx | 1 December 2018 |
| 30 tablet, film coated in 1 bottle | 63187-943-30 | Proficient Rx | 1 January 2018 |
| 60 tablet, film coated in 1 bottle | 63187-943-60 | Proficient Rx | 1 January 2018 |
| 90 tablet, film coated in 1 bottle | 63187-943-90 | Proficient Rx | 1 January 2018 |
| 30 tablet, film coated in 1 bottle | 71205-249-30 | Proficient Rx | 1 April 2019 |
| 60 tablet, film coated in 1 bottle | 71205-249-60 | Proficient Rx | 1 April 2019 |
| 90 tablet, film coated in 1 bottle | 71205-249-90 | Proficient Rx | 1 April 2019 |
| 30 tablet, film coated in 1 bottle | 71205-327-30 | Proficient Rx | 21 January 2020 |
| 60 tablet, film coated in 1 bottle | 71205-327-60 | Proficient Rx | 21 January 2020 |
| 90 tablet, film coated in 1 bottle | 71205-327-90 | Proficient Rx | 21 January 2020 |
| 90 tablet, film coated in 1 bottle | 50090-3292-0 | A-S Medication Solutions | 1 December 2017 |
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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 6 March 1998 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US 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 Hydrochlorothiazide and Valsartan 12.5 mg/80 mg tablet.
Other strengths and forms of Hydrochlorothiazide and Valsartan
Clinical summary
Hydrochlorothiazide and Valsartan is a fixed-dose combination of an angiotensin 2 receptor blocker and a thiazide diuretic indicated for the treatment of hypertension, to lower blood pressure. It is available as tablets for oral use. MedsAcross supplies Hydrochlorothiazide and Valsartan 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 ValsartanFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Diovan HCT prescribing information (Novartis Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Hydrochlorothiazide and Valsartan 12.5 mg/80 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.