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United States· US:66993-457_4cdea416-6da9-411e-aa5a-ba78fc388844

DAPAGLIFLOZIN

A sodium-glucose co-transporter 2 (sglt2) inhibitors product containing dapagliflozin, registered in United States by Prasco Laboratories.

ATC A10BKOrange 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…normalisedDAPAGLIFLOZINATCA10BKREGISTER NO.US:66993-457_4cdea416…PACKS LISTED1CHECKEDSeptember 12, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about dapagliflozinAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
DAPAGLIFLOZIN
Manufacturer
Prasco Laboratories
Country
United States (US)
ATC code
A10BK
ATC class
Sodium-glucose co-transporter 2 (SGLT2) inhibitors
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 12, 2026

Packs & prices · 1

  • ndc11
    6699345730
    30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (66993-457-30)

Regulatory notes

UNII (FDA substance ID)
887K2391VH
DAPAGLIFLOZIN PROPANEDIOL
RxCUI 1486966
Orange Book
N202293
ABAB
DailyMed SPL labels
1 version tracked

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.

All dapagliflozin products

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/cc0b1193-560f-4eb2-b501-128d517b2a32
GET /v1/drugs/cc0b1193-560f-4eb2-b501-128d517b2a32?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": "887K2391VH",
    "rxcui": "1486966",
    "inchikey": "GOADIQFWSVMMRJ-UPGAGZFNSA-N",
    "display_name": "DAPAGLIFLOZIN PROPANEDIOL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "livertox": {
    "summary": null,
    "livertox_id": null,
    "hepatotoxicity_score": 4
  },
  "spl_meta": {
    "52a778e7-6044-2049-e063-6294a90aa0b7": {
      "match": "brand_token",
      "title": "DAPAGLIFLOZIN TABLET, FILM COATED [AVKARE]",
      "spl_version": "2",
      "published_date": "2026-05-28"
    }
  },
  "productid": "66993-457_4cdea416-6da9-411e-aa5a-ba78fc388844",
  "productndc": "66993-457",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "202293",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Jan 8, 2014"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Jan 8, 2014"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DAPAGLIFLOZIN PROPANEDIOL",
  "proprietary_name": "DAPAGLIFLOZIN",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA202293",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "DAPAGLIFLOZIN",
  "start_marketing_date": "20240103",
  "active_numerator_strength": "10"
}
API referenceMCP serverPlans

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.

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