United States· US:0006-5363_1616eabd-2ed5-4a98-b255-964e73b63dc8
STEGLATRO
A medicinal product containing ertugliflozin, registered in United States by Merck Sharp & Dohme LLC.
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
- ertugliflozin
- Manufacturer
- Merck Sharp & Dohme LLC
- 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 · 5
- ndc11000653630330 TABLET, FILM COATED in 1 BOTTLE (0006-5363-03)
- ndc11000653630690 TABLET, FILM COATED in 1 BOTTLE (0006-5363-06)
- ndc110006536307500 TABLET, FILM COATED in 1 BOTTLE (0006-5363-07)
- ndc1100065363092 BOTTLE in 1 CARTON (0006-5363-09) / 7 TABLET, FILM COATED in 1 BOTTLE (0006-5363-08)
- ndc11000653631030 TABLET, FILM COATED in 1 BOTTLE (0006-5363-10)
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Ertugliflozin in 8 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaSTEGLATROMerck Sharp & Dohme B.V., Haarlem
- SwitzerlandSteglatro 5 mg, FilmtablettenMSD Merck Sharp & Dohme AG
- SpainSTEGLATRO 5 MG COMPRIMIDOS RECUBIERTOS CON PELICULAMerck Sharp & Dohme B.V.
- IcelandSteglatroMerck Sharp & Dohme B.V.*
- PolandSteglatroMerck Sharp & Dohme B.V.
- SwedenSteglatro 5 mg Filmdragerad tablettMerck Sharp & Dohme BV
- United KingdomSteglatro 15mg tabletsMerck Sharp & Dohme (UK) Ltd
- ItalySTEGLATRO*28 cpr rivestite 15 mgMERCK SHARP & DOHME BV
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Steglatro
- Liechtenstein · Steglatro
- Norway · Steglatro
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/06444090-60cf-4f12-826b-ea4c1e682bf0 GET /v1/drugs/06444090-60cf-4f12-826b-ea4c1e682bf0?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": 5
},
"productid": "0006-5363_1616eabd-2ed5-4a98-b255-964e73b63dc8",
"productndc": "0006-5363",
"dosage_form": "TABLET, FILM COATED",
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ERTUGLIFLOZIN PIDOLATE",
"proprietary_name": "STEGLATRO",
"active_ingred_unit": "mg/1",
"application_number": "NDA209803",
"marketing_category": "NDA",
"nonproprietary_name": "ertugliflozin",
"start_marketing_date": "20171219",
"active_numerator_strength": "5"
}See everything about ertugliflozin.
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.