Medicine
Amlodipine, Hydrochlorothiazide and Valsartan 10 mg/25 mg/160 mg tablet
Amlodipine, Hydrochlorothiazide and Valsartan 10 mg/25 mg/160 mg tablet is a generic prescription medicine for oral use, made by 5 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° to 25°C (68° to 77°F), excursions permitted to 15º to 30°C (59º…
Key facts
- Active ingredient (INN)
- Amlodipine, Hydrochlorothiazide and Valsartan
- Brand
- Sold under the generic name
- Strength
- 10 mg/25 mg/160 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 500 tablets, 30 tablets, 90 tablets and 7 more
- Manufacturers
- Aurobindo PharmaIndiaMacleods PharmaceuticalsIndiaStrides PharmaIndiaGolden State Medical Supply5 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted to 15º to 30°C (59º to 86°F) Protect from moisture.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C09DX01 Amlodipine, Hydrochlorothiazide and Valsartan
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 June 2015
- Identifiers
- RxCUI 848131, 848135, 848140 +2DailyMed set ID 9b76e441-e6a5-4036-8276-b7788ade5c44, e9ecbadb-c548-6fe5-e053-2a95a90a7577, 6fba5243-ee00-4825-a04a-321cb6b49c56 +2NDC 64380-200, 51407-671, 65862-837 +2Application ANDA201087, ANDA206180, ANDA207299 +1
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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 500 tablet, film coated in 1 bottle | 65862-837-05 | Aurobindo PharmaIndia | 19 December 2017 |
| 30 tablet, film coated in 1 bottle | 65862-837-30 | Aurobindo PharmaIndia | 19 December 2017 |
| 90 tablet, film coated in 1 bottle | 65862-837-90 | Aurobindo PharmaIndia | 19 December 2017 |
| 30 tablet, film coated in 1 bottle | 33342-286-07 | Macleods PharmaceuticalsIndia | 6 January 2025 |
| 90 tablet, film coated in 1 bottle | 33342-286-10 | Macleods PharmaceuticalsIndia | 6 January 2025 |
| 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 33342-286-12 | Macleods PharmaceuticalsIndia | 6 January 2025 |
| 30 tablet, film coated in 1 bottle | 64380-200-01 | Strides PharmaIndia | 27 June 2022 |
| 90 tablet, film coated in 1 bottle | 64380-200-02 | Strides PharmaIndia | 27 June 2022 |
| 500 tablet, film coated in 1 bottle | 64380-200-03 | Strides PharmaIndia | 27 June 2022 |
| 30 tablet, film coated in 1 bottle | 51407-671-30 | Golden State Medical Supply | 1 August 2022 |
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.
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 Amlodipine, Hydrochlorothiazide and Valsartan 10 mg/25 mg/160 mg tablet.
Other strengths and forms of Amlodipine, Hydrochlorothiazide and Valsartan
Clinical summary
Amlodipine, Hydrochlorothiazide and Valsartan is a fixed-dose combination of an angiotensin 2 receptor blocker, a calcium channel blocker and a dihydropyridine calcium channel blocker indicated for the treatment of hypertension, to lower blood pressure. MedsAcross supplies Amlodipine, 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 Amlodipine, 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
- Exforge HCT prescribing information (Novartis Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Copalia HCT: European public assessment report (EPAR) · European Medicines Agency
- Dafiro HCT: European public assessment report (EPAR) · European Medicines Agency
Need Amlodipine, Hydrochlorothiazide and Valsartan 10 mg/25 mg/160 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.