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United States· US:68462-569_6de4a776-9973-4410-ae04-99544813d920

Amlodipine and Olmesartan Medoxomil

A medicinal product containing amlodipine besylate; olmesartan medoxomil, registered in United States by Glenmark Pharmaceuticals Inc., USA.

US label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedAmlodipine and Olmesartan MedoxomilATC—REGISTER NO.US:68462-569_6de4a776…PACKS LISTED6CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
Manufacturer
Glenmark Pharmaceuticals Inc., USA
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 · 6

  • ndc11
    68462-569-14
  • ndc11
    68462-569-30
  • ndc11
    68462-569-90
  • ndc11
    6846256914
    10 BLISTER PACK in 1 CARTON (68462-569-14) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • ndc11
    6846256930
    30 TABLET, FILM COATED in 1 BOTTLE (68462-569-30)
  • ndc11
    6846256990
    90 TABLET, FILM COATED in 1 BOTTLE (68462-569-90)

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.

All amlodipine besylate; olmesartan medoxomil products

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/c0630dfb-8ac9-4316-84e2-a41839ee7cd6
GET /v1/drugs/c0630dfb-8ac9-4316-84e2-a41839ee7cd6?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": "10; 40",
  "substance": "AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL",
  "productndc": "68462-569",
  "dosage_form": "TABLET, FILM COATED",
  "dea_schedule": null,
  "strength_unit": "mg/1; mg/1",
  "application_number": "ANDA207807",
  "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.