United States· US:65862-854_4879a01c-0ba7-4d27-9847-f22e8546fa8f
Amlodipine and Olmesartan Medoxomil
A medicinal product containing amlodipine besylate; olmesartan medoxomil, registered in United States by Aurobindo Pharma Limited.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
- Manufacturer
- Aurobindo Pharma Limited
- Country
- United States (US)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 2
- ndc11658628543030 TABLET, FILM COATED in 1 BOTTLE (65862-854-30)
- ndc1165862-854-30
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Amlodipine besylate; olmesartan medoxomil in 6 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaOLMESARTAN/AMLODIPIN ZENTIVAZentiva, k.s., Praha
- ItalyBIVISMENARINI INTERNAT. O.L.S.A
- GermanyOlmeamloTad Pharma Gmbh
- FinlandAleaMenarini International Operations Luxembourg S.A.
- IrelandKonverge 20 mg/5 mg film-coated tabletsMenarini International Operations Luxembourg S.A.
- FranceAXELER 20 mg/5 mg, comprimé pelliculéMENARINI INTERNATIONAL OPERATIONS LUXEMBOURG
Authorised across Europe · EMA
The same active substance is authorised in 26 EEA countries. Names it is sold under:
- Austria · Amelior, Olmesartan/Amlodipin 1a Pharma
- Belgium · Forzaten, Forzaten®
- Bulgaria · Amlodipine Besilate / Olmesartan Medoxomil Viatris Limited, Амлосарт
- Cyprus · Alsamod, Comprelan
- Czechia · Olmesartan/Amlodipin Zentiva, Olssa
- Germany · Olmeamlo, Olmeamlodipin Puren
- Estonia · Olmesartan Medoxomil/Amlodipine Accord, Olmesartan Medoxomil/Amlodipine Zentiva
- Spain · Albis, Balzak
- Finland · Olmesartan Medoxomil/Amlodipine Krka
- France · Axeler, Sevikar
- United Kingdom (Northern Ireland) · Olmesartan Medoxomil And Amlodipine Clydesdale Pharma, Olmesartan Medoxomil/Amlodipine Accord Healthcare
- Greece · Comprelan, Olmedipin
- Croatia · Olmita
- Hungary · Duactan, Olmiza
- Ireland · Konverge, Olmesartan /Amlodipine Mylan
- Italy · Bivis, Giant
- Lithuania · Olmesartan Medoxomil /Amlodipine Sandoz, Olmesartan Medoxomil/Amlodipine Accord
- Luxembourg · Forzaten, Olmesartan/Amlodipine Eg
- Latvia · Olmesartan Medoxomil/ Amlodipine Zentiva, Olssa
- Malta · Konverge, Olmesartan Medoxomil/Amlodipine Ascend
- Netherlands · Amlodipine Besylate/ Olmesartan Medoxomil Aurobindo, Amlodipine Besylate/Olmesartan Medoxomil Aurobindo
- Poland · Elestar, Olmita
- Portugal · Amlodipina + Olmesartan Medoxomilo Alter, Amlodipina + Olmesartan Medoxomilo Aurovitas
- Romania · Almacor Duo, Inovum
- Slovenia · Olectan, Olmita
- Slovakia · Folgan
Source: European Medicines Agency, Article 57 product data.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/efcc64bf-4921-465a-bc73-1b3deb2d304c GET /v1/drugs/efcc64bf-4921-465a-bc73-1b3deb2d304c?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"route": "ORAL",
"source": "ndc",
"strength": "5; 20",
"substance": "AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL",
"productndc": "65862-854",
"dosage_form": "TABLET, FILM COATED",
"dea_schedule": null,
"strength_unit": "mg/1; mg/1",
"application_number": "ANDA206906",
"marketing_category": "ANDA"
}See everything about amlodipine besylate; olmesartan medoxomil.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.