United States· US:71610-900_334f174d-fe96-517d-e063-6394a90a8d4d

Jardiance

A empagliflozin product containing empagliflozin, registered in United States by Aphena Pharma Solutions - Tennessee, LLC. The same ATC class is registered in 16 of our 19 countries.

ATC A10BK03Orange BookUS 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…normalisedJardianceATCA10BK03REGISTER NO.US:71610-900_334f174d…PACKS LISTED1CHECKEDSeptember 12, 2026

Where it is registered

Empagliflozin is registered in 16 of 19 countries.

Countries holding a registration under ATC A10BK03 (empagliflozin), each read from that country’s own register.

  • This record: United States, from FDA National Drug Code directory (United States)
  • 9 of them publish a price we can compare per daily dose

Empagliflozin · ATC A10BK03

16 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Germany
  • Icelandprice
  • Ireland
  • Italyprice
  • Japan
  • Netherlands
  • Norwayprice
  • Polandprice
  • Switzerlandprice
  • United Kingdom
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

Price per daily dose

What a daily dose of empagliflozin costs, country by country.

Normalised to the WHO defined daily dose (17.5 mg), so markets compare like for like.

  • 2 markets with a comparable price for this class
  • Public list prices, converted to USD at the rate date shown

Empagliflozin · price per daily dose (17.5 mg)

USD · FX 28 Sept 2026

  • CH Switzerland$3.80
  • IT Italy$2.95
Median listed price per WHO defined daily dose, in each market that publishes a price. Open the full comparison

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
Empagliflozin
Manufacturer
Aphena Pharma Solutions - Tennessee, LLC
Country
United States (US)
ATC code
A10BK03
ATC class
Empagliflozin
Defined daily dose
17.5 mg, O
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 12, 2026

Packs & prices · 1

  • ndc11
    7161090009
    9000 TABLET, FILM COATED in 1 BOTTLE (71610-900-09)

Regulatory notes

UNII (FDA substance ID)
HDC1R2M35U
EMPAGLIFLOZIN
RxCUI 1545653
Orange Book
N204629
DailyMed SPL labels
1 version tracked

Interactions

466 interactions on record for empagliflozin.

Graded by severity as the source publishes them — 1 severe. Severity grades are free for everyone; mechanism and management come with Growth.

  • Severity for every pair — free, no plan needed
  • The source, licence and sync date on every record
  • Mechanism and what to do for each pair — Growth plan

Empagliflozin · interactions on record

466 records

  • 1 severe
  • 425 moderate
  • 40 minor

Most severe, free to view

  • SucralfateA02BX02moderate
  • PapaverineA03AD01moderate
  • ThiethylperazinA04AB03moderate
  • TriflupromazinA04AD06moderate
  • Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

Same medicine, other countries

Empagliflozin in 16 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All empagliflozin products

Authorised across Europe · EMA

The same active substance is authorised in 29 EEA countries. Names it is sold under:

  • Austria · Empagliflozin Denk, Empagliflozin Devatis
  • Belgium · Empagliflozin Ab, Empagliflozine Hcs
  • Bulgaria · Глузод, Емлигекса
  • Cyprus · Glusod
  • Czechia · Empagliflozin Polpharma, Empelic
  • Germany · Empagliflozin Devatis, Emprables
  • Denmark · Bifoglan, Elemio
  • Estonia · Glusod
  • Spain · Empagliflozina Aurovitas, Empagliflozina Kern Pharma
  • Finland · Empagliflozin Devatis, Empagliflozin Reddy
  • United Kingdom (Northern Ireland) · Empagliflozin, Empagliflozin G.L. Pharma
  • Greece · Elemio, Empagliflozin Pharmapath
  • Croatia · Glusod
  • Hungary · Empagliflozin Polpharma
  • Ireland · Empagliflozin Krka
  • Iceland · Empagliflozin Reddy, Empagliflozin Wh 10 Mg
  • Liechtenstein · Jardiance
  • Lithuania · Embeflyx, Emlygexa
  • Luxembourg · Empagliflozin Ab
  • Latvia · Embeflyx, Emlygexa
  • Malta · Empagliflozin Denk, Eprekavor
  • Netherlands · Empagliflozine Devatis, Empagliflozine Doc
  • Norway · Empagliflozin Devatis, Empagliflozin Reddy
  • Poland · Empelic
  • Portugal · Empagliflozina Aurobindo, Empagliflozina Aurovitas
  • Romania · Glusod
  • Sweden · Empagliflozin Devatis, Empagliflozin Labiana
  • Slovenia · Empagliflozin Krka, Glusod
  • Slovakia · Empagliflozin Polpharma, Glusod

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/a60b1938-ea13-4d33-bd3a-dea64bb46995
GET /v1/drugs/a60b1938-ea13-4d33-bd3a-dea64bb46995?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.

{
  "unii": {
    "unii": "HDC1R2M35U",
    "rxcui": "1545653",
    "inchikey": "OBWASQILIWPZMG-QZMOQZSNSA-N",
    "display_name": "EMPAGLIFLOZIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "livertox": {
    "summary": null,
    "livertox_id": null,
    "hepatotoxicity_score": 5
  },
  "spl_meta": {
    "5777b8a8-ada6-4950-8548-43a1de11f075": {
      "match": "brand_token",
      "title": "JARDIANCE (EMPAGLIFLOZIN) TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]",
      "spl_version": "13",
      "published_date": "2026-02-23"
    }
  },
  "productid": "71610-900_334f174d-fe96-517d-e063-6394a90a8d4d",
  "productndc": "71610-900",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "204629",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Aug 1, 2014"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "25MG",
        "product_no": "002",
        "approval_date": "Aug 1, 2014"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "EMPAGLIFLOZIN",
  "proprietary_name": "Jardiance",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA204629",
  "marketing_category": "NDA",
  "nonproprietary_name": "Empagliflozin",
  "start_marketing_date": "20140801",
  "active_numerator_strength": "10"
}

See everything about empagliflozin.

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.