United States· US:80830-2465_ef0abec7-d5c4-4de2-8474-f16006304101

Metronidazole

A medicinal product containing metronidazole, registered in United States by Amneal Pharmaceuticals Private Limited.

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…normalisedMetronidazoleATC—REGISTER NO.US:80830-2465_ef0abec…PACKS LISTED2CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
METRONIDAZOLE
Manufacturer
Amneal Pharmaceuticals Private 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

  • ndc11
    8083024659
    24 POUCH in 1 CARTON (80830-2465-9) / 1 BAG in 1 POUCH (80830-2465-1) / 100 mL in 1 BAG
  • ndc11
    80830-2465-9

Regulatory notes

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

Same medicine, other countries

Metronidazole in 16 other countries

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

All metronidazole products

Authorised across Europe · EMA

The same active substance is authorised in 30 EEA countries. Names it is sold under:

  • Austria · Anaerobex, Metronidazol B. Braun
  • Belgium · Flagyl, Metronidazole B. Braun
  • Bulgaria · Aрилин, Арилин Рапид
  • Cyprus · Colpocin-T, Flagymet
  • Czechia · Efloran, Entizol
  • Germany · Arilin, Arilin Rapid
  • Denmark · Metronidazol Actavis, Metronidazol Avia Pharma
  • Estonia · Arilin, Metronidazol Orifarm
  • Spain · Flagyl, Intizol Vaginal
  • Finland · Arilin, Flagyl
  • France · Flagyl, Métronidazole Arrow
  • United Kingdom (Northern Ireland) · Acea, Anabact
  • Greece · Colpocin-T, Emedal
  • Croatia · Arilin Rapid, Efloran
  • Hungary · Klion, Metronidazol Noridem
  • Ireland · Flagyl, Flagyl-S
  • Iceland · Flagyl, Metronidazol Actavis
  • Italy · Deflamon, Flagyl
  • Lithuania · Arilin, Arilin Rapid
  • Luxembourg · Flagyl, Metronidazol B. Braun
  • Latvia · Arilin, Arilin Rapid
  • Malta · Metronidazole B. Braun, Metronidazole Remedica
  • Netherlands · Flagyl, Metronidazol Aurobindo
  • Norway · Flagyl, Metronidazol Actavis
  • Poland · Arilin Rapid, Metronidazol Aurovitas
  • Portugal · Dabenzol, Dumozol
  • Romania · Metronidazol Arena, Metronidazol B Infomed Fluids
  • Sweden · Flagyl, Metronidazol Actavis
  • Slovenia · Efloran, Metronidazol Braun
  • Slovakia · Efloran, Entizol

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/4f9d1d8e-6771-4267-9764-bcbb8ab98ca3
GET /v1/drugs/4f9d1d8e-6771-4267-9764-bcbb8ab98ca3?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": "INTRAVENOUS",
  "source": "ndc",
  "strength": "500",
  "substance": "METRONIDAZOLE",
  "productndc": "80830-2465",
  "dosage_form": "INJECTION, SOLUTION",
  "dea_schedule": null,
  "strength_unit": "mg/100mL",
  "application_number": "ANDA217665",
  "marketing_category": "ANDA"
}

See everything about metronidazole.

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.