United States· US:0378-8176_09385285-c5a1-444e-9c2e-64da50e2a508
Saxagliptin and Metformin
A medicinal product containing saxagliptin and 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
- saxagliptin and 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
- June 3, 2026
Packs & prices · 1
- ndc11037881769160 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-8176-91)
Regulatory notes
No shortage, Orange Book or US label notes for this record.
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/f21b7812-e92a-43a4-a89f-8bd13ed76edc GET /v1/drugs/f21b7812-e92a-43a4-a89f-8bd13ed76edc?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",
"productid": "0378-8176_09385285-c5a1-444e-9c2e-64da50e2a508",
"productndc": "0378-8176",
"dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE DIHYDRATE",
"proprietary_name": "Saxagliptin and Metformin",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA205981",
"marketing_category": "ANDA",
"nonproprietary_name": "saxagliptin and metformin",
"start_marketing_date": "20230808",
"active_numerator_strength": "1000; 2.5"
}See everything about saxagliptin and 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.