Medicine
Hyzaar 12.5 mg/100 mg tablet
Hyzaar 12.5 mg/100 mg tablet is a prescription medicine containing Hydrochlorothiazide and Losartan for oral use, marketed by Organon, 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 77°F (25°C), excursions permitted to 59°F to 86°F (15°C to 30°C)…
Key facts
- Active ingredient (INN)
- Hydrochlorothiazide and Losartan
- Brand
- Hyzaar
- Strength
- 12.5 mg/100 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 30 tablets, 90 tablets
- Marketing authorisation holder
- Organon
- Manufacturer
- Organon
- Origin register
- US FDA, United States
- Storage
- Store at 77°F (25°C), excursions permitted to 59°F to 86°F (15°C to 30°C). 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
- 1 June 2021
- Identifiers
- RxCUI 979464, 979466, 979468 +3DailyMed set ID 4116ccde-2e23-45f4-b12f-6337df877744NDC 78206-140Application NDA020387
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
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/100 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 Hyzaar 12.5 mg/100 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.