United States· US:0378-6001_7c8e06cd-8ef3-4a03-b4ee-3df6899280cf
Metformin Hydrochloride
A medicinal product containing metformin, registered in United States by Mylan Pharmaceuticals Inc..
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
- metformin
- Manufacturer
- Mylan Pharmaceuticals 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 12, 2026
Packs & prices · 1
- ndc11037860019160 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-6001-91)
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Metformin in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- FinlandDiformin RetardTakeda Oy
- CzechiaBROTMINMedochemie Ltd., Limassol
- United KingdomAxpinet 500mg tabletsGlucoRx Ltd
- PolandAbmetfina XRTarchomińskie Zakłady Farmaceutyczne "Polfa" S.A.
- ItalyGLUCOPHAGEBRUNO FARMACEUTICI S.P.A.
- SpainBROTMIN 1000 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFGMedochemie Iberia S.A.
- SwedenForminet 1000 mg Filmdragerad tablettSTADA Arzneimittel AG
- SwitzerlandGlucophage 1000
Authorised across Europe · EMA
The same active substance is authorised in 30 EEA countries. Names it is sold under:
- Austria · Diabetex, Glucophage
- Belgium · Metformax, Metformin Activase 1000 Mg
- Bulgaria · Meglucon Xr, Metformin Interdos Pharma
- Cyprus · Brotmin, Glucophage
- Czechia · Brotmin, Glucomet
- Germany · Glucophage, Juformin
- Denmark · Forminet, Lyomet
- Estonia · Brotmin, Diabufor Xr
- Spain · Brotmin, Dianben
- Finland · Forminet, Glucophage
- France · Glimezit, Glucophage
- United Kingdom (Northern Ireland) · Abiano, Axpinet
- Greece · Glucoformin, Glucofree
- Croatia · Aglurab, Belformin
- Hungary · Adimet, Adimet Xr
- Ireland · Glucophage, Metformin Accord
- Iceland · Forminet, Glucophage
- Italy · Glucophage, Glucophage Unidie
- Lithuania · Brotmin, Metfogamma
- Luxembourg · Glucophage, Metformax
- Latvia · Brotmin, Glucient Sr
- Malta · Brotmin, Glyformin
- Netherlands · Glucient Sr, Glycofren
- Norway · Forminet, Glucophage
- Poland · Abmetfina Xr, Avamina
- Portugal · Allmet, Glucophage
- Romania · Brotmin, Glucophage
- Sweden · Forminet, Glucophage
- Slovenia · Aglurab, Glucophage
- Slovakia · Glucophage, Glucophage Xr
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/ee749983-7c7e-4697-a67a-45cd4e58b24a GET /v1/drugs/ee749983-7c7e-4697-a67a-45cd4e58b24a?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",
"livertox": {
"summary": null,
"livertox_id": null,
"hepatotoxicity_score": 2
},
"productid": "0378-6001_7c8e06cd-8ef3-4a03-b4ee-3df6899280cf",
"productndc": "0378-6001",
"dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "METFORMIN HYDROCHLORIDE",
"proprietary_name": "Metformin Hydrochloride",
"active_ingred_unit": "mg/1",
"application_number": "ANDA200690",
"marketing_category": "ANDA",
"nonproprietary_name": "metformin",
"start_marketing_date": "20160823",
"active_numerator_strength": "1000"
}See everything about metformin.
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.