Medicine
Amlodipine, Hydrochlorothiazide and Olmesartan 5 mg/12.5 mg/40 mg tablet
Amlodipine, Hydrochlorothiazide and Olmesartan 5 mg/12.5 mg/40 mg tablet is a generic prescription medicine for oral use, made by 6 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
They are supplied as Bottle of 30 tablets (NDC 31722-896-30) Bottle of 90…
Key facts
- Active ingredient (INN)
- Amlodipine, Hydrochlorothiazide and Olmesartan
- Brand
- Sold under the generic name
- Strength
- 5 mg/12.5 mg/40 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 30 tablets, 10 blister pack, 90 tablets and 11 more
- Manufacturers
- Micro LabsIndiaCamber PharmaceuticalsIndiaMacleods PharmaceuticalsIndiaPar HealthSlate Run PharmaceuticalsTeva Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- They are supplied as Bottle of 30 tablets (NDC 31722-896-30) Bottle of 90 tablets (NDC 31722-896-90) Blister Card of 10 Unit dose tablets (NDC 31722-896-31) Carton of 100 (10 x 10) Unit dose tablets (NDC 31722-896-32) Stored at 20° to 25°C (68° to 77°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 October 2016
- Identifiers
- RxCUI 999967, 999986, 999991 +2DailyMed set ID 45e975ff-07b1-411a-96ee-a011d1619b1e, 268d12e8-1cfc-4086-b613-8fd94f2d7c4e, a469adff-25a6-4983-b471-60924d920a86 +3NDC 31722-893, 49884-787, 70436-015 +3Application ANDA209242, ANDA206137, ANDA210718 +3
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 | 31722-893-30 | Camber PharmaceuticalsIndia | 6 October 2025 |
| 10 blister pack in 1 carton / 8 tablet, film coated in 1 blister pack | 31722-893-32 | Camber PharmaceuticalsIndia | 6 October 2025 |
| 90 tablet, film coated in 1 bottle | 31722-893-90 | Camber PharmaceuticalsIndia | 6 October 2025 |
| 30 tablet, film coated in 1 bottle | 33342-244-07 | Macleods PharmaceuticalsIndia | 18 July 2025 |
| 90 tablet, film coated in 1 bottle | 33342-244-10 | Macleods PharmaceuticalsIndia | 18 July 2025 |
| 500 tablet, film coated in 1 bottle | 42571-246-05 | Micro LabsIndia | 1 March 2026 |
| 1000 tablet, film coated in 1 bottle | 42571-246-10 | Micro LabsIndia | 1 March 2026 |
| 30 tablet, film coated in 1 bottle | 42571-246-30 | Micro LabsIndia | 1 March 2026 |
| 90 tablet, film coated in 1 bottle | 42571-246-90 | Micro LabsIndia | 1 March 2026 |
| 90 tablet, film coated in 1 bottle | 49884-787-09 | Par Health | 26 October 2016 |
| 30 tablet, film coated in 1 bottle | 49884-787-11 | Par Health | 26 October 2016 |
| 30 tablet, film coated in 1 bottle | 70436-015-04 | Slate Run Pharmaceuticals | 15 May 2025 |
| 90 tablet, film coated in 1 bottle | 70436-015-06 | Slate Run Pharmaceuticals | 15 May 2025 |
| 30 tablet, film coated in 1 bottle | 0093-5006-56 | Teva Pharmaceuticals | 14 November 2016 |
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 23 July 2010 | 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, Hydrochlorothiazide and Olmesartan 5 mg/12.5 mg/40 mg tablet.
Other strengths and forms of Amlodipine, Hydrochlorothiazide and Olmesartan
Clinical summary
Amlodipine, Hydrochlorothiazide 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, Hydrochlorothiazide 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, Hydrochlorothiazide 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
- Tribenzor prescribing information (Cosette Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Amlodipine, Hydrochlorothiazide and Olmesartan 5 mg/12.5 mg/40 mg tablet for your hospital or patient?
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