United States· US:0480-3527_64caba8e-fb3b-4238-96f1-9155c22bf021
DAPAGLIFLOZIN
A medicinal product containing dapagliflozin, registered in United States by Teva 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
- DAPAGLIFLOZIN
- Manufacturer
- Teva 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 · 2
- ndc11048035275630 TABLET, FILM COATED in 1 BOTTLE (0480-3527-56)
- ndc11048035279890 TABLET, FILM COATED in 1 BOTTLE (0480-3527-98)
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Dapagliflozin in 17 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaDAPAGLIFLOZIN AVIANTAAvianta Pharma EU Limited, Dublin
- PolandDaforbisViatris Ltd
- SpainDAFORBIS 5 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFGViatris Limited
- NetherlandsDapagliflozine Accord 5 mg filmomhulde tablettenAccord Healthcare B.V.
- SwedenDaforbis 5 mg Filmdragerad tablettViatris Limited
- SwitzerlandDapagliflozin Devatis 5 mg, FilmtablettenDevatis AG
- IcelandDapagliflozin KrkaKrka, d.d., Novo mesto
- IrelandDapagliflozin MSN 5 mg film-coated tabletsMSN Labs Europe Limited
Authorised across Europe · EMA
The same active substance is authorised in 31 EEA countries. Names it is sold under:
- Austria · Dapagliflozin +pharma, Dapagliflozin Devatis
- Belgium · Dapagliflozin Ab, Dapagliflozin Eg
- Bulgaria · Dapagliflozin Sandoz, Dapagliflozin Tchaikapharma
- Cyprus · Daforbis, Dapagliflozin Farmoz
- Czechia · Dagetia, Dagrafors
- Germany · Daglin, Dapagliflozin 123-Acurae Pharma
- Denmark · Dapagliflozin, Dapagliflozin "sandoz"
- Estonia · Dagrafors, Dapagliflozin Alembic
- Spain · Daforbis, Dapagliflozina Aurovitas
- Finland · Dapagliflozin Devatis, Dapagliflozin Krka
- France · Dapagliflozine Arrow, Dapagliflozine Biogaran
- United Kingdom (Northern Ireland) · Daforbis, Dapagliflozin
- Greece · Brolertix, Daforbis
- Croatia · Daforbis, Dagrafors
- Hungary · Dagrafors, Dapagliflozin Sandoz
- Ireland · Dapagliflozin Clonmel, Dapagliflozin Krka
- Iceland · Dapagliflozin Krka, Dapagliflozin Krka D.D.
- Italy · Dapagliflozin Aurobindo, Dapagliflozin Doc
- Liechtenstein · Dapagliflozin Viatris, Edistride
- Lithuania · Dagrafors, Dapagliflozin Accord
- Luxembourg · Dapagliflozin Eg
- Latvia · Daglin, Dagrafors
- Malta · Dapagliflozin Ascend, Dapagliflozin Aurobindo
- Netherlands · Dapagliflozin Alembic, Dapagliflozin Amarox
- Norway · Dapagliflozin Alembic, Dapagliflozin Devatis
- Poland · Daforbis, Dagrafors
- Portugal · Dalzior, Dapagliflozin Ipca
- Romania · Daforbis, Dagetia
- Sweden · Daforbis, Dapagliflozin Adalvo
- Slovenia · Dagrafors, Dapagliflozin Hcs
- Slovakia · Dagetia, Dagrafors
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/c180ddc1-87da-4176-b1e7-17ad11dc1421 GET /v1/drugs/c180ddc1-87da-4176-b1e7-17ad11dc1421?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": 4
},
"productid": "0480-3527_64caba8e-fb3b-4238-96f1-9155c22bf021",
"productndc": "0480-3527",
"dosage_form": "TABLET, FILM COATED",
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DAPAGLIFLOZIN",
"proprietary_name": "DAPAGLIFLOZIN",
"active_ingred_unit": "mg/1",
"application_number": "ANDA211541",
"marketing_category": "ANDA",
"nonproprietary_name": "DAPAGLIFLOZIN",
"start_marketing_date": "20260408",
"active_numerator_strength": "5"
}See everything about dapagliflozin.
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.