Medicine
Amlodipine and Telmisartan 5 mg/80 mg tablet
Amlodipine and Telmisartan 5 mg/80 mg tablet is a generic prescription medicine for oral use, made by 2 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 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F)…
Key facts
- Active ingredient (INN)
- Amlodipine and Telmisartan
- Brand
- Sold under the generic name
- Strength
- 5 mg/80 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 30 blister pack, 30 tablets and 2 more
- Manufacturers
- Alembic PharmaceuticalsIndiaMylan Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F). Protect from moisture and light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C09DB04 Amlodipine and Telmisartan
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 19 September 2014
- Identifiers
- RxCUI 876514, 876519, 876524 +1DailyMed set ID 14f9b590-4c43-439c-a647-9fc2b0fd4d7f, ca60a4d5-ace7-4889-94ee-e2265fd63811, 15b438b4-4874-43f4-a50a-4e6f3e5530acNDC 62332-186, 0378-1077, 46708-186Application ANDA205234, ANDA202516
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 |
|---|---|---|---|
| 30 blister pack in 1 carton / 10 tablet in 1 blister pack | 46708-186-10 | Alembic PharmaceuticalsIndia | 31 March 2026 |
| 30 tablet in 1 bottle | 46708-186-30 | Alembic PharmaceuticalsIndia | 31 March 2026 |
| 30 blister pack in 1 carton / 10 tablet in 1 blister pack | 62332-186-10 | Alembic PharmaceuticalsIndia | 31 March 2026 |
| 30 tablet in 1 bottle | 62332-186-30 | Alembic PharmaceuticalsIndia | 31 March 2026 |
| 30 tablet in 1 bottle, plastic | 0378-1077-93 | Mylan Pharmaceuticals | 19 September 2014 |
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
Other strengths and forms of Amlodipine and Telmisartan
Clinical summary
Amlodipine and Telmisartan 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, among other approved uses. MedsAcross supplies Amlodipine and Telmisartan 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 TelmisartanFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Telmisartan and Amlodipine prescribing information (Alembic Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Twynsta: European public assessment report (EPAR) · European Medicines Agency
Need Amlodipine and Telmisartan 5 mg/80 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.