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United States· US:0555-0483_3c6d3a11-6d0b-4109-89cd-658827847fea

Amiloride Hydrochloride and Hydrochlorothiazide

A medicinal product containing amiloride hydrochloride; hydrochlorothiazide, registered in United States by Teva Pharmaceuticals USA, Inc..

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…normalisedAmiloride Hydrochloride and Hydrochlo…ATC—REGISTER NO.US:0555-0483_3c6d3a11…PACKS LISTED4CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
Manufacturer
Teva Pharmaceuticals USA, Inc.
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 · 4

  • ndc11
    0555048302
    100 TABLET in 1 BOTTLE (0555-0483-02)
  • ndc11
    0555048305
    1000 TABLET in 1 BOTTLE (0555-0483-05)
  • ndc11
    0555-0483-02
  • ndc11
    0555-0483-05

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Same medicine, other countries

Amiloride hydrochloride; hydrochlorothiazide in 12 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All amiloride hydrochloride; hydrochlorothiazide products

Authorised across Europe · EMA

The same active substance is authorised in 19 EEA countries. Names it is sold under:

  • Cyprus · Milorex
  • Czechia · Loradur, Loradur Mite
  • Germany · Amilorid Comp Ratiopharm, Amilorid Comp.-Ratiopharm
  • Denmark · Amilco
  • Spain · Ameride, Amilorida/Hidroclorotiazida Aurovitas
  • Finland · Amitrid, Amitrid Mite
  • France · Amiloride Hydrochlorothiazide Teva
  • United Kingdom (Northern Ireland) · Co-Amilozide, Co-Amilozide Wockhardt Uk
  • Greece · Tiaden
  • Hungary · Amilorid Comp Pharmavit, Amilozid
  • Iceland · Amiloride/Hct Alvogen
  • Italy · Amiloride E Idroclorotiazide Aurobindo, Moduretic
  • Malta · Milorex
  • Netherlands · Amiloride Hcl/Hydrochloorthiazide Accord, Amiloride Hydrochloride/Hydrochlorothiazide Aurobindo
  • Norway · Normorix Mite
  • Poland · Tialorid, Tialorid Mite
  • Portugal · Amilorida + Hidroclorotiazida Generis, Amiloride + Hidroclorotiazida Ratiopharm
  • Sweden · Amiloferm, Amiloferm Mite
  • Slovakia · Rhefluin

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/24d12dcd-207f-4072-8ab9-6ac9417be052
GET /v1/drugs/24d12dcd-207f-4072-8ab9-6ac9417be052?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; 50",
  "substance": "AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE",
  "productndc": "0555-0483",
  "dosage_form": "TABLET",
  "dea_schedule": null,
  "strength_unit": "mg/1; mg/1",
  "application_number": "ANDA071111",
  "marketing_category": "ANDA"
}

See everything about amiloride hydrochloride; hydrochlorothiazide.

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.