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United States· US:0378-7185_bd9cf158-94b6-42b0-b2d6-7d185b6ac310

Metformin Hydrochloride

A medicinal product containing metformin hydrochloride, registered in United States by Mylan Pharmaceuticals Inc..

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…normalisedMetformin HydrochlorideATC—REGISTER NO.US:0378-7185_bd9cf158…PACKS LISTED1CHECKEDSeptember 12, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
metformin hydrochloride
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

  • ndc11
    0378718505
    500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-7185-05)

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/e7625996-6e3d-4679-80c6-62c6a6f69740
GET /v1/drugs/e7625996-6e3d-4679-80c6-62c6a6f69740?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": "0378-7185_bd9cf158-94b6-42b0-b2d6-7d185b6ac310",
  "productndc": "0378-7185",
  "dosage_form": "TABLET, FILM COATED",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METFORMIN HYDROCHLORIDE",
  "proprietary_name": "Metformin Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA075973",
  "marketing_category": "ANDA",
  "nonproprietary_name": "metformin hydrochloride",
  "start_marketing_date": "20100603",
  "active_numerator_strength": "500"
}

See everything about 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.