United States· US:65841-825_99ca3856-ca2b-4a2d-b1a1-bd70f8f740b4
glyburide and metformin hydrochloride
A medicinal product containing glyburide; metformin hydrochloride, registered in United States by Zydus Lifesciences 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
- GLYBURIDE; METFORMIN HYDROCHLORIDE
- Manufacturer
- Zydus Lifesciences 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 · 6
- ndc1165841-825-01
- ndc1165841-825-05
- ndc1165841-825-06
- ndc1165841-825-10
- ndc1165841-825-16
- ndc1165841-825-77
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Glyburide; metformin hydrochloride in 3 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- FranceGLUCOVANCE 1000 mg/5 mg, comprimé pelliculéMERCK SANTE
- ItalyDIAGLIMETABIOGEN PHARMA S.P.A.
- CzechiaGLIBOMETLaboratori Guidotti S.p.A., La Vettola, (Pisa)
Authorised across Europe · EMA
The same active substance is authorised in 7 EEA countries. Names it is sold under:
- Czechia · Glibomet
- France · Glucovance
- Italy · Diaglimet, Glibomet
- Portugal · Glucovance
- Romania · Bidiab, Glibomet
- Slovenia · Glucovance
- Slovakia · Glibomet
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/470008b7-a283-47e2-81d7-564534f05ecf GET /v1/drugs/470008b7-a283-47e2-81d7-564534f05ecf?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": "2.5; 500",
"substance": "GLYBURIDE; METFORMIN HYDROCHLORIDE",
"productndc": "65841-825",
"dosage_form": "TABLET",
"dea_schedule": null,
"strength_unit": "mg/1; mg/1",
"application_number": "ANDA206748",
"marketing_category": "ANDA"
}See everything about glyburide; metformin hydrochloride.
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.