United States· US:65862-694_f56928ba-4263-4212-ae2e-d89fcc7bea68
Metronidazole
A medicinal product containing metronidazole, 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
- METRONIDAZOLE
- 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 · 10
- ndc1165862-694-05
- ndc1165862-694-25
- ndc1165862-694-50
- ndc1165862-694-99
- ndc116586269401100 TABLET in 1 BOTTLE (65862-694-01)
- ndc116586269405500 TABLET in 1 BOTTLE (65862-694-05)
- ndc116586269425250 TABLET in 1 BOTTLE (65862-694-25)
- ndc11658626945050 TABLET in 1 BOTTLE (65862-694-50)
- ndc1165862694991000 TABLET in 1 BOTTLE (65862-694-99)
- ndc1165862-694-01
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.
- FinlandMetrobactin vetDechra Regulatory B.V.
- CanadaAPO-METRONIDAZOLE TABLETSAPOTEX INC
- SwitzerlandMetrolag 250 mg, compresseLagap SA
- CzechiaENTIZOLZaklady Farmaceutyczne Polpharma SA, Starogard Gdański
- SpainMETRONIDAZOL NORMON 250 mg COMPRIMIDOS EFGLaboratorios Normon S.A.
- ItalyFLAGYLTEOFARMA S.R.L.
- PolandMetronidazol PolpharmaZakłady Farmaceutyczne POLPHARMA S.A.
- United KingdomAcea 0.75% gelFerndale Pharmaceuticals Ltd
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/f8322626-be2c-42ab-afc5-e952deea43ff GET /v1/drugs/f8322626-be2c-42ab-afc5-e952deea43ff?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": "250",
"substance": "METRONIDAZOLE",
"productndc": "65862-694",
"dosage_form": "TABLET",
"dea_schedule": null,
"strength_unit": "mg/1",
"application_number": "ANDA203974",
"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.