Medicine
Amlodipine and Valsartan 10 mg/320 mg tablet
Amlodipine and Valsartan 10 mg/320 mg tablet is a generic prescription medicine for oral use, made by 8 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 o to 25 • C (68 o to 77 • F), excursions permitted to 15 o to 30 •…
Key facts
- Active ingredient (INN)
- Amlodipine and Valsartan
- Brand
- Sold under the generic name
- Strength
- 10 mg/320 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 30 tablets, 500 tablets and 21 more
- Manufacturers
- Alembic PharmaceuticalsIndiaAurobindo PharmaIndiaMacleods PharmaceuticalsIndiaAvet PharmaceuticalsIndiaCadila PharmaceuticalsIndiaLupinIndiaGolden State Medical SupplyMylan Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20 o to 25 • C (68 o to 77 • F), excursions permitted to 15 o to 30 • C (59 o to 86 • F). Protect from moisture.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C09DB01 Amlodipine and Valsartan
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 28 March 2013
- Identifiers
- RxCUI 722126, 722131, 722134 +1DailyMed set ID 5dfadaf0-c333-4b79-9a97-e42f77505c40, 7fa25f10-29e0-4162-81a8-9d2e03054ded, fed14445-1117-861a-e053-6294a90a2aa3 +7NDC 33342-282, 65862-740, 51407-774 +7Application ANDA207292, ANDA206512, ANDA090011 +5
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 |
|---|---|---|---|
| 100 tablet, film coated in 1 carton | 46708-461-10 | Alembic PharmaceuticalsIndia | 1 December 2016 |
| 30 tablet, film coated in 1 bottle | 46708-461-30 | Alembic PharmaceuticalsIndia | 1 December 2016 |
| 100 tablet, film coated in 1 bottle | 46708-461-31 | Alembic PharmaceuticalsIndia | 1 December 2016 |
| 500 tablet, film coated in 1 bottle | 46708-461-71 | Alembic PharmaceuticalsIndia | 1 December 2016 |
| 90 tablet, film coated in 1 bottle | 46708-461-90 | Alembic PharmaceuticalsIndia | 1 December 2016 |
| 100 tablet, film coated in 1 carton | 62332-208-10 | Alembic PharmaceuticalsIndia | 1 December 2016 |
| 30 tablet, film coated in 1 bottle | 62332-208-30 | Alembic PharmaceuticalsIndia | 1 December 2016 |
| 100 tablet, film coated in 1 bottle | 62332-208-31 | Alembic PharmaceuticalsIndia | 1 December 2016 |
| 500 tablet, film coated in 1 bottle | 62332-208-71 | Alembic PharmaceuticalsIndia | 1 December 2016 |
| 90 tablet, film coated in 1 bottle | 62332-208-90 | Alembic PharmaceuticalsIndia | 1 December 2016 |
| 30 tablet in 1 bottle | 43386-080-03 | LupinIndia | 30 March 2015 |
| 90 tablet in 1 bottle | 43386-080-09 | LupinIndia | 30 March 2015 |
| 3 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 65862-740-03 | Aurobindo PharmaIndia | 22 April 2016 |
| 30 tablet, film coated in 1 bottle | 65862-740-30 | Aurobindo PharmaIndia | 22 April 2016 |
| 90 tablet, film coated in 1 bottle | 65862-740-90 | Aurobindo PharmaIndia | 22 April 2016 |
| 30 tablet in 1 bottle, plastic | 23155-847-03 | Avet PharmaceuticalsIndia | 15 March 2023 |
| 90 tablet in 1 bottle, plastic | 23155-847-09 | Avet PharmaceuticalsIndia | 15 March 2023 |
| 30 tablet, film coated in 1 bottle | 71209-024-01 | Cadila PharmaceuticalsIndia | 22 October 2026 |
| 90 tablet, film coated in 1 bottle | 71209-024-04 | Cadila PharmaceuticalsIndia | 22 October 2026 |
| 30 tablet in 1 bottle | 33342-282-07 | Macleods PharmaceuticalsIndia | 16 October 2024 |
| 90 tablet in 1 bottle | 33342-282-10 | Macleods PharmaceuticalsIndia | 16 October 2024 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 33342-282-12 | Macleods PharmaceuticalsIndia | 16 October 2024 |
| 30 tablet, film coated in 1 bottle, plastic | 0378-1724-93 | Mylan Pharmaceuticals | 30 March 2015 |
| 30 tablet in 1 bottle, plastic | 51407-774-30 | Golden State Medical Supply | 6 May 2023 |
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 and Valsartan 10 mg/320 mg tablet.
Other strengths and forms of Amlodipine and Valsartan
Clinical summary
Amlodipine 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 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 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 prescribing information (Novartis Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Copalia: European public assessment report (EPAR) · European Medicines Agency
- Dafiro: European public assessment report (EPAR) · European Medicines Agency
Need Amlodipine and Valsartan 10 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.