Medicine
Hydrochlorothiazide and Losartan 12.5 mg/50 mg tablet
Hydrochlorothiazide and Losartan 12.5 mg/50 mg tablet is a generic prescription medicine for oral use, made by 22 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 to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C…
Key facts
- Active ingredient (INN)
- Hydrochlorothiazide and Losartan
- Brand
- Sold under the generic name
- Strength
- 12.5 mg/50 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 blister pack, 30 tablets, 90 tablets and 90 more
- Manufacturers
- Alembic PharmaceuticalsIndiaAurobindo PharmaIndiaJubilant Cadista PharmaceuticalsIndiaMacleods PharmaceuticalsIndiaUnichem LaboratoriesIndiaCamber PharmaceuticalsIndiaGranules IndiaIndiaLupinIndiaSolco HealthcareTeva Pharmaceuticals22 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light.
- 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
- 6 April 2010
- Identifiers
- RxCUI 979468, 979471, 979464DailyMed set ID 42942482-1f54-4c7f-9d5f-4aaf20abb3e3, 3c873a8c-b21e-448e-87f3-333419739cdd, 198d5151-7982-4639-9fe1-6573a4529348 +31NDC 71335-2127, 72162-2462, 63187-599 +32Application ANDA204901, ANDA204832, ANDA091629 +7
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 22 labelers. The register lists 93 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 46708-448-10 | Alembic PharmaceuticalsIndia | 23 May 2016 |
| 30 tablet, film coated in 1 bottle | 46708-448-30 | Alembic PharmaceuticalsIndia | 23 May 2016 |
| 90 tablet, film coated in 1 bottle | 46708-448-90 | Alembic PharmaceuticalsIndia | 23 May 2016 |
| 1000 tablet, film coated in 1 bottle | 46708-448-91 | Alembic PharmaceuticalsIndia | 23 May 2016 |
| 100 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 62332-048-10 | Alembic PharmaceuticalsIndia | 23 May 2016 |
| 30 tablet, film coated in 1 bottle | 62332-048-30 | Alembic PharmaceuticalsIndia | 23 May 2016 |
| 90 tablet, film coated in 1 bottle | 62332-048-90 | Alembic PharmaceuticalsIndia | 23 May 2016 |
| 1000 tablet, film coated in 1 bottle | 62332-048-91 | Alembic PharmaceuticalsIndia | 23 May 2016 |
| 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 65862-468-10 | Aurobindo PharmaIndia | 6 October 2010 |
| 30 tablet, film coated in 1 bottle | 65862-468-30 | Aurobindo PharmaIndia | 6 October 2010 |
| 3000 tablet, film coated in 1 bottle | 65862-468-39 | Aurobindo PharmaIndia | 6 October 2010 |
| 90 tablet, film coated in 1 bottle | 65862-468-90 | Aurobindo PharmaIndia | 6 October 2010 |
| 1000 tablet, film coated in 1 bottle | 65862-468-99 | Aurobindo PharmaIndia | 6 October 2010 |
| 1000 tablet, film coated in 1 bottle | 31722-755-10 | Camber PharmaceuticalsIndia | 27 May 2026 |
| 30 tablet, film coated in 1 bottle | 31722-755-30 | Camber PharmaceuticalsIndia | 27 May 2026 |
| 90 tablet, film coated in 1 bottle | 31722-755-90 | Camber PharmaceuticalsIndia | 27 May 2026 |
| 30 tablet, film coated in 1 bottle | 70010-187-03 | Granules IndiaIndia | 29 September 2023 |
| 1000 tablet, film coated in 1 bottle | 70010-187-10 | Granules IndiaIndia | 29 September 2023 |
| 100 tablet, film coated in 1 bottle | 59746-337-01 | Jubilant Cadista PharmaceuticalsIndia | 30 October 2012 |
| 1000 tablet, film coated in 1 bottle | 59746-337-10 | Jubilant Cadista PharmaceuticalsIndia | 30 October 2012 |
| 30 tablet, film coated in 1 bottle | 59746-337-30 | Jubilant Cadista PharmaceuticalsIndia | 30 October 2012 |
| 90 tablet, film coated in 1 bottle | 59746-337-90 | Jubilant Cadista PharmaceuticalsIndia | 30 October 2012 |
| 30 tablet in 1 bottle | 68180-215-06 | LupinIndia | 6 October 2010 |
| 90 tablet in 1 bottle | 68180-215-09 | LupinIndia | 6 October 2010 |
| 30 tablet, film coated in 1 bottle | 33342-050-07 | Macleods PharmaceuticalsIndia | 10 September 2012 |
| 90 tablet, film coated in 1 bottle | 33342-050-10 | Macleods PharmaceuticalsIndia | 10 September 2012 |
| 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 33342-050-12 | Macleods PharmaceuticalsIndia | 10 September 2012 |
| 1000 tablet, film coated in 1 bottle | 33342-050-44 | Macleods PharmaceuticalsIndia | 10 September 2012 |
| 100 tablet, film coated in 1 bottle, plastic | 29300-190-01 | Unichem LaboratoriesIndia | 15 January 2018 |
| 1000 tablet, film coated in 1 bottle, plastic | 29300-190-10 | Unichem LaboratoriesIndia | 15 January 2018 |
| 30 tablet, film coated in 1 bottle, plastic | 29300-190-13 | Unichem LaboratoriesIndia | 15 January 2018 |
| 90 tablet, film coated in 1 bottle, plastic | 29300-190-19 | Unichem LaboratoriesIndia | 15 January 2018 |
| 30 tablet, film coated in 1 bottle | 43547-423-03 | Solco Healthcare | 15 February 2018 |
| 90 tablet, film coated in 1 bottle | 43547-423-09 | Solco Healthcare | 15 February 2018 |
| 1000 tablet, film coated in 1 bottle | 43547-423-11 | Solco Healthcare | 15 February 2018 |
| 1000 tablet, film coated in 1 bottle | 0093-7367-10 | Teva Pharmaceuticals | 6 April 2010 |
| 30 tablet, film coated in 1 bottle | 0093-7367-56 | Teva Pharmaceuticals | 6 April 2010 |
| 90 tablet, film coated in 1 bottle | 0093-7367-98 | Teva Pharmaceuticals | 6 April 2010 |
| 90 tablet, film coated in 1 bottle | 50090-2632-0 | A-S Medication Solutions | 17 November 2016 |
| 30 tablet, film coated in 1 bottle | 50090-2632-1 | A-S Medication Solutions | 1 December 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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 28 April 1995 | 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 Losartan 12.5 mg/50 mg tablet.
Other strengths and forms of Hydrochlorothiazide and Losartan
Clinical summary
Hydrochlorothiazide and Losartan is a fixed-dose combination of an angiotensin 2 receptor blocker and a thiazide diuretic indicated for treatment of hypertension, to lower blood pressure, among other approved uses. MedsAcross supplies Hydrochlorothiazide and Losartan 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 LosartanFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- HYZAAR prescribing information (Organon) · U.S. National Library of Medicine, DailyMed
Need Hydrochlorothiazide and Losartan 12.5 mg/50 mg tablet for your hospital or patient?
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