United States· US:47335-506_9db609da-42a0-42b1-87f5-020261a871ad

CEQUA

A ciclosporin product containing cyclosporine, registered in United States by Sun Pharmaceutical Industries, Inc.. The same ATC class is registered in 14 of our 19 countries.

ATC S01XA18Orange 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…normalisedCEQUAATCS01XA18REGISTER NO.US:47335-506_9db609da…PACKS LISTED1CHECKEDSeptember 12, 2026

Where it is registered

Ciclosporin is registered in 14 of 19 countries.

Countries holding a registration under ATC S01XA18 (ciclosporin), 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

Ciclosporin · ATC S01XA18

14 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Italyprice
  • 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.

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
cyclosporine
Manufacturer
Sun Pharmaceutical Industries, Inc.
Country
United States (US)
ATC code
S01XA18
ATC class
Ciclosporin
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 12, 2026

Packs & prices · 1

  • ndc11
    4733550696
    6 POUCH in 1 BOX (47335-506-96) / 10 VIAL, SINGLE-DOSE in 1 POUCH / .25 mL in 1 VIAL, SINGLE-DOSE

Regulatory notes

UNII (FDA substance ID)
83HN0GTJ6D
CYCLOSPORINE
RxCUI 3008
Orange Book
N210913
DailyMed SPL labels
1 version tracked

Same medicine, other countries

Ciclosporin in 16 other countries

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

All ciclosporin products

Authorised across Europe · EMA

The same active substance is authorised in 31 EEA countries. Names it is sold under:

  • Austria · Cequa®, Neoimmun
  • Belgium · Neoral-Sandimmun, Sandimmun
  • Bulgaria · Сандимун Неорал
  • Cyprus · Sandimmun Neoral
  • Czechia · Ciclosporin Viatris, Equoral
  • Germany · Cequa, Cicloral
  • Denmark · Ciqorin, Menelri
  • Estonia · Equoral, Sandimmun Neoral
  • Spain · Cequa, Ciqorin
  • Finland · Cequa, Ciqorin
  • France · Cequa, Ciclograft
  • United Kingdom (Northern Ireland) · Capimune, Capsorin
  • Greece · Imunofar, Sandimmun
  • Croatia · Ciklosporin Alkaloid, Equoral
  • Hungary · Sandimmun, Sandimmun Neoral
  • Ireland · Deximune, Neoral
  • Iceland · Ciqorin, Ikervis
  • Italy · Cequa, Ciqorin
  • Liechtenstein · Ikervis, Verkazia
  • Lithuania · Equoral, Sandimmun Neoral
  • Luxembourg · Neoral-Sandimmun, Sandimmun
  • Latvia · Sandimmun Neoral
  • Malta · Deximune, Sandimmun Neoral
  • Netherlands · Cequa, Ciclosporin Teva
  • Norway · Cequa, Ikervis
  • Poland · Cyclaid, Equoral
  • Portugal · Ciclosporina Flica Germed Farmacêutica, Ciclosporina Generis
  • Romania · Cequa, Sandimmun Neoral
  • Sweden · Cequa, Ciklosporin Ivax
  • Slovenia · Sandimmun, Sandimmun Neoral
  • Slovakia · Ciclosporin Viatris, Equoral

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/25191fc6-2a36-4163-a885-8406e8e50754
GET /v1/drugs/25191fc6-2a36-4163-a885-8406e8e50754?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": "83HN0GTJ6D",
    "rxcui": "3008",
    "inchikey": "PMATZTZNYRCHOR-CGLBZJNRSA-N",
    "display_name": "CYCLOSPORINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC; TOPICAL",
  "livertox": {
    "summary": null,
    "livertox_id": null,
    "hepatotoxicity_score": 3
  },
  "spl_meta": {
    "48c3d8a3-4289-4b52-9189-58b48596095c": {
      "match": "brand_token",
      "title": "CEQUA (CYCLOSPORINE) SOLUTION/ DROPS [SUN PHARMACEUTICAL INDUSTRIES, INC.]",
      "spl_version": "12",
      "published_date": "2025-03-10"
    }
  },
  "productid": "47335-506_9db609da-42a0-42b1-87f5-020261a871ad",
  "productndc": "47335-506",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "210913",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.09%",
        "product_no": "001",
        "approval_date": "Aug 14, 2018"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CYCLOSPORINE",
  "proprietary_name": "CEQUA",
  "active_ingred_unit": "g/mL",
  "application_number": "NDA210913",
  "marketing_category": "NDA",
  "nonproprietary_name": "cyclosporine",
  "start_marketing_date": "20180815",
  "active_numerator_strength": ".0009"
}

See everything about ciclosporin.

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.