Back to search

United States· US:67046-0366_513b5796-97cd-f095-e063-6394a90a79ae

AMOXICILLIN AND CLAVULANATE POTASSIUM

A medicinal product containing amoxicillin; clavulanate potassium, registered in United States by Coupler LLC.

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…normalisedAMOXICILLIN AND CLAVULANATE POTASSIUMATC—REGISTER NO.US:67046-0366_513b579…PACKS LISTED2CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Manufacturer
Coupler LLC
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

  • ndc11
    6704603663
    30 TABLET, FILM COATED in 1 BLISTER PACK (67046-0366-3)
  • ndc11
    67046-0366-3

Regulatory notes

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

Same medicine, other countries

Amoxicillin; clavulanate potassium in 5 other countries

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

All amoxicillin; clavulanate potassium products

Authorised across Europe · EMA

The same active substance is authorised in 21 EEA countries. Names it is sold under:

  • Austria · Amoclavaxin, Amoxicillin/Clavulansäure Actavis
  • Belgium · Amoclane, Amoclaneeg
  • Bulgaria · Амоксиклав
  • Czechia · Amoxicillin/Clavulanic Acid Olikla
  • Germany · Amoxicillin Comp. Ratiopharm, Amoxicillin Ratiopharm
  • Estonia · Amoxicillin/Clavulanic Acid Actavis, Amoxicillin/Clavulanic Acid Sun
  • Spain · Amoxicilina / Acido Clavulanico Bluefish, Amoxicilina/ Acido Clavulanico Tevagen
  • Finland · Amoxin Comp
  • France · Amoxicilline / Acide Clavulanique Kabi, Amoxicilline/ Acide Clavulanique Kabi
  • United Kingdom (Northern Ireland) · Co-Amoxiclav, Co-Amoxiclav 500mg/125mg
  • Croatia · Klavax Bid
  • Hungary · Aksolin, Amoxicillin/Klavulánsav Kabi
  • Ireland · Co-Amoxiclav, Germentin
  • Italy · Amoxicillina E Acido Clavulanico, Amoxicillina E Acido Clavulanico Ibigen
  • Lithuania · Amoxicillin/Clavulanic Acid Actavis
  • Netherlands · Amoxicilline/Clavulaanzuur Fresenius Kabi
  • Poland · Co-Amoxiclav, Co-Amoxiclav Bluefish
  • Portugal · Amoxicilina + Ácido Clavulânico Alter, Amoxicilina + Ácido Clavulânico Gp
  • Romania · Amoksiklav, Enhancin
  • Slovenia · Amoksiklav, Amoksiklav Solvo
  • Slovakia · Amoksiklav, Amoxicillin/Clavulanic Acid Olikla

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/f0da8871-56b6-4dbd-891c-a9650814c11c
GET /v1/drugs/f0da8871-56b6-4dbd-891c-a9650814c11c?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": "500; 125",
  "substance": "AMOXICILLIN; CLAVULANATE POTASSIUM",
  "productndc": "67046-0366",
  "dosage_form": "TABLET, FILM COATED",
  "dea_schedule": null,
  "strength_unit": "mg/1; mg/1",
  "application_number": "ANDA205707",
  "marketing_category": "ANDA"
}

See everything about amoxicillin; clavulanate potassium.

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.