Medicine
Amlodipine and Olmesartan 5 mg/40 mg tablet
Amlodipine and Olmesartan 5 mg/40 mg tablet is a generic prescription medicine for oral use, made by 11 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°C-30°C (59°F-86°F).
Key facts
- Active ingredient (INN)
- Amlodipine and Olmesartan
- Brand
- Sold under the generic name
- Strength
- 5 mg/40 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 30 tablets, 90 tablets, 1000 tablets and 24 more
- Manufacturers
- Alembic PharmaceuticalsIndiaMacleods PharmaceuticalsIndiaMicro LabsIndiaAjanta PharmaIndiaAscend LaboratoriesIndiaCamber PharmaceuticalsIndiaAurobindo PharmaIndiaScieGen PharmaceuticalsAmneal Pharmaceuticals NYAvKARE
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), excursions permitted to 15°C-30°C (59°F-86°F).
- 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
- 26 September 2007
- Identifiers
- RxCUI 730861, 730866, 730869 +1DailyMed set ID 69fa6293-b10a-4473-ab9b-1bd53f099bdd, 02f9b562-6f7f-4783-bb0d-67c318073e1c, c531fceb-09aa-492b-a5a3-2b004e9eadda +9NDC 27241-084, 69238-2676, 50228-366 +9Application ANDA207216, ANDA209010, ANDA206884 +6
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 tablet, film coated in 1 bottle | 46708-213-30 | Alembic PharmaceuticalsIndia | 18 July 2017 |
| 90 tablet, film coated in 1 bottle | 46708-213-90 | Alembic PharmaceuticalsIndia | 18 July 2017 |
| 1000 tablet, film coated in 1 bottle | 46708-213-91 | Alembic PharmaceuticalsIndia | 18 July 2017 |
| 30 tablet, film coated in 1 bottle | 62332-213-30 | Alembic PharmaceuticalsIndia | 18 July 2017 |
| 90 tablet, film coated in 1 bottle | 62332-213-90 | Alembic PharmaceuticalsIndia | 18 July 2017 |
| 1000 tablet, film coated in 1 bottle | 62332-213-91 | Alembic PharmaceuticalsIndia | 18 July 2017 |
| 30 tablet in 1 bottle | 27241-084-03 | Ajanta PharmaIndia | 6 February 2017 |
| 90 tablet in 1 bottle | 27241-084-09 | Ajanta PharmaIndia | 6 February 2017 |
| 30 tablet in 1 bottle | 67877-501-30 | Ascend LaboratoriesIndia | 14 August 2017 |
| 90 tablet in 1 bottle | 67877-501-90 | Ascend LaboratoriesIndia | 14 August 2017 |
| 30 tablet, film coated in 1 bottle | 65862-855-30 | Aurobindo PharmaIndia | 15 May 2017 |
| 30 tablet, film coated in 1 bottle | 31722-446-30 | Camber PharmaceuticalsIndia | 14 February 2025 |
| 90 tablet, film coated in 1 bottle | 31722-446-90 | Camber PharmaceuticalsIndia | 14 February 2025 |
| 30 tablet, film coated in 1 bottle | 33342-191-07 | Macleods PharmaceuticalsIndia | 27 October 2016 |
| 90 tablet, film coated in 1 bottle | 33342-191-10 | Macleods PharmaceuticalsIndia | 27 October 2016 |
| 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 33342-191-12 | Macleods PharmaceuticalsIndia | 27 October 2016 |
| 1000 tablet, film coated in 1 bottle | 33342-191-44 | Macleods PharmaceuticalsIndia | 27 October 2016 |
| 500 tablet in 1 bottle | 42571-237-05 | Micro LabsIndia | 1 January 2018 |
| 1000 tablet in 1 bottle | 42571-237-10 | Micro LabsIndia | 1 January 2018 |
| 30 tablet in 1 bottle | 42571-237-30 | Micro LabsIndia | 1 January 2018 |
| 90 tablet in 1 bottle | 42571-237-90 | Micro LabsIndia | 1 January 2018 |
| 1000 tablet, film coated in 1 bottle | 69238-2676-1 | Amneal Pharmaceuticals NY | 3 December 2018 |
| 1000 tablet, film coated in 1 bottle | 50228-366-10 | ScieGen Pharmaceuticals | 3 December 2018 |
| 30 tablet, film coated in 1 bottle | 50228-366-30 | ScieGen Pharmaceuticals | 3 December 2018 |
| 90 tablet, film coated in 1 bottle | 50228-366-90 | ScieGen Pharmaceuticals | 3 December 2018 |
| 30 tablet, film coated in 1 bottle | 42291-002-30 | AvKARE | 18 June 2024 |
| 30 tablet, film coated in 1 bottle, plastic | 51407-859-30 | Golden State Medical Supply | 13 May 2024 |
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 26 September 2007 | 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 Amlodipine and Olmesartan 5 mg/40 mg tablet.
Other strengths and forms of Amlodipine and Olmesartan
Clinical summary
Amlodipine and Olmesartan is a fixed-dose combination of an angiotensin 2 receptor blocker, a calcium channel blocker and a dihydropyridine calcium channel blocker. It is available as tablets for oral use. MedsAcross supplies Amlodipine and Olmesartan 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 OlmesartanFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Azor prescribing information (Cosette Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Amlodipine and Olmesartan 5 mg/40 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.