Medicine
Hydrochlorothiazide and Olmesartan 12.5 mg/40 mg tablet
Hydrochlorothiazide and Olmesartan 12.5 mg/40 mg tablet is a generic prescription medicine for oral use, made by 18 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 20-25ºC (68-77ºF).
Key facts
- Active ingredient (INN)
- Hydrochlorothiazide and Olmesartan
- Brand
- Sold under the generic name
- Strength
- 12.5 mg/40 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 80 tablets, 100 tablets, 30 tablets and 68 more
- Manufacturers
- Alembic PharmaceuticalsIndiaUmedica LaboratoriesIndiaAurobindo PharmaIndiaLifestar PharmaIndiaMacleods PharmaceuticalsIndiaMicro LabsIndiaCamber PharmaceuticalsIndiaNovadoz PharmaceuticalsIndiaAscend LaboratoriesIndiaAccord HealthcareIndia18 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20-25ºC (68-77ºF).
- 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
- 24 April 2017
- Identifiers
- RxCUI 403853, 403854, 403855DailyMed set ID 017bc6a3-5b3d-2381-e063-6394a90abece, 3df6c955-9c38-4e44-a665-dac2a051bd02, d421f352-9500-4d3e-8bc3-0cdcc2050514 +25NDC 42291-925, 50090-5402, 31722-887 +25Application NDA021532, ANDA209281, ANDA209199 +9
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 18 labelers. The register lists 71 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 80 tablet in 1 carton | 46708-150-08 | Alembic PharmaceuticalsIndia | 24 April 2017 |
| 100 tablet in 1 carton | 46708-150-10 | Alembic PharmaceuticalsIndia | 24 April 2017 |
| 30 tablet in 1 bottle | 46708-150-30 | Alembic PharmaceuticalsIndia | 24 April 2017 |
| 90 tablet in 1 bottle | 46708-150-90 | Alembic PharmaceuticalsIndia | 24 April 2017 |
| 1000 tablet in 1 bottle | 46708-150-91 | Alembic PharmaceuticalsIndia | 24 April 2017 |
| 80 tablet in 1 carton | 62332-150-08 | Alembic PharmaceuticalsIndia | 24 April 2017 |
| 100 tablet in 1 carton | 62332-150-10 | Alembic PharmaceuticalsIndia | 24 April 2017 |
| 30 tablet in 1 bottle | 62332-150-30 | Alembic PharmaceuticalsIndia | 24 April 2017 |
| 90 tablet in 1 bottle | 62332-150-90 | Alembic PharmaceuticalsIndia | 24 April 2017 |
| 1000 tablet in 1 bottle | 62332-150-91 | Alembic PharmaceuticalsIndia | 24 April 2017 |
| 90 tablet, film coated in 1 bottle | 16729-367-15 | Accord HealthcareIndia | 3 September 2020 |
| 30 tablet, film coated in 1 bottle | 67877-452-30 | Ascend LaboratoriesIndia | 1 May 2025 |
| 90 tablet, film coated in 1 bottle | 67877-452-90 | Ascend LaboratoriesIndia | 1 May 2025 |
| 30 tablet, film coated in 1 bottle | 65862-780-30 | Aurobindo PharmaIndia | 24 April 2017 |
| 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 65862-780-78 | Aurobindo PharmaIndia | 24 April 2017 |
| 90 tablet, film coated in 1 bottle | 65862-780-90 | Aurobindo PharmaIndia | 24 April 2017 |
| 1000 tablet, film coated in 1 bottle | 65862-780-99 | Aurobindo PharmaIndia | 24 April 2017 |
| 30 tablet, film coated in 1 bottle | 31722-887-30 | Camber PharmaceuticalsIndia | 25 July 2025 |
| 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 31722-887-32 | Camber PharmaceuticalsIndia | 25 July 2025 |
| 90 tablet, film coated in 1 bottle | 31722-887-90 | Camber PharmaceuticalsIndia | 25 July 2025 |
| 1000 tablet in 1 bottle | 70756-813-12 | Lifestar PharmaIndia | 1 October 2020 |
| 30 tablet in 1 bottle | 70756-813-30 | Lifestar PharmaIndia | 1 October 2020 |
| 500 tablet in 1 bottle | 70756-813-51 | Lifestar PharmaIndia | 1 October 2020 |
| 90 tablet in 1 bottle | 70756-813-90 | Lifestar PharmaIndia | 1 October 2020 |
| 30 tablet, film coated in 1 bottle | 33342-174-07 | Macleods PharmaceuticalsIndia | 2 June 2023 |
| 90 tablet, film coated in 1 bottle | 33342-174-10 | Macleods PharmaceuticalsIndia | 2 June 2023 |
| 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 33342-174-12 | Macleods PharmaceuticalsIndia | 2 June 2023 |
| 1000 tablet, film coated in 1 bottle | 33342-174-44 | Macleods PharmaceuticalsIndia | 2 June 2023 |
| 500 tablet, film coated in 1 bottle | 42571-205-05 | Micro LabsIndia | 15 October 2026 |
| 1000 tablet, film coated in 1 bottle | 42571-205-10 | Micro LabsIndia | 15 October 2026 |
| 30 tablet, film coated in 1 bottle | 42571-205-30 | Micro LabsIndia | 15 October 2026 |
| 90 tablet, film coated in 1 bottle | 42571-205-90 | Micro LabsIndia | 15 October 2026 |
| 30 tablet, film coated in 1 bottle | 72205-148-30 | Novadoz PharmaceuticalsIndia | 30 September 2025 |
| 90 tablet, film coated in 1 bottle | 72205-148-90 | Novadoz PharmaceuticalsIndia | 30 September 2025 |
| 1000 tablet, film coated in 1 bottle | 72205-148-99 | Novadoz PharmaceuticalsIndia | 30 September 2025 |
| 30 tablet in 1 bottle | 60290-025-01 | Umedica LaboratoriesIndia | 15 February 2026 |
| 90 tablet in 1 bottle | 60290-025-02 | Umedica LaboratoriesIndia | 15 February 2026 |
| 1000 tablet in 1 bottle | 60290-025-03 | Umedica LaboratoriesIndia | 15 February 2026 |
| 100 tablet in 1 blister pack | 60290-025-04 | Umedica LaboratoriesIndia | 15 February 2026 |
| 500 tablet in 1 bottle | 60290-025-05 | Umedica LaboratoriesIndia | 15 February 2026 |
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 5 June 2003 | 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 Olmesartan 12.5 mg/40 mg tablet.
Other strengths and forms of Hydrochlorothiazide and Olmesartan
Clinical summary
Hydrochlorothiazide and Olmesartan 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, among other approved uses. MedsAcross supplies Hydrochlorothiazide and Olmesartan 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 OlmesartanFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Benicar HCT prescribing information (Cosette Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Hydrochlorothiazide and Olmesartan 12.5 mg/40 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.