Medicine
Diovan HCT 12.5 mg/320 mg tablet
Diovan HCT 12.5 mg/320 mg tablet is a prescription medicine containing Hydrochlorothiazide and Valsartan for oral use, marketed by Novartis Pharmaceuticals, 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 between 15°C and…
Key facts
- Active ingredient (INN)
- Hydrochlorothiazide and Valsartan
- Brand
- Diovan HCT
- Strength
- 12.5 mg/320 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 90 tablets
- Marketing authorisation holder
- Novartis Pharmaceuticals
- Manufacturer
- Novartis Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 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
- 28 April 2006
- Identifiers
- RxCUI 200284, 200285, 349353 +7DailyMed set ID d76a0419-05ee-437e-884c-65807aea9569NDC 0078-0471Application NDA020818
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 90 tablet, film coated in 1 bottle | 0078-0471-34 | Novartis Pharmaceuticals | 28 April 2006 |
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/320 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 Diovan HCT 12.5 mg/320 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.