United States· US:27241-295_ac2afe93-a78a-4dfe-8759-fec53f872e35

Prucalopride

A prucalopride product containing prucalopride, registered in United States by Ajanta Pharma USA Inc.. The same ATC class is registered in 15 of our 19 countries.

ATC A06AX05Orange 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…normalisedPrucaloprideATCA06AX05REGISTER NO.US:27241-295_ac2afe93…PACKS LISTED1CHECKEDSeptember 12, 2026

Where it is registered

Prucalopride is registered in 15 of 19 countries.

Countries holding a registration under ATC A06AX05 (prucalopride), 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

Prucalopride · ATC A06AX05

15 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Germany
  • Icelandprice
  • Ireland
  • 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 prucalopride costs, country by country.

Normalised to the WHO defined daily dose (2 mg), so markets compare like for like.

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

Prucalopride · price per daily dose (2 mg)

USD · FX 28 Sept 2026

  • CH Switzerland$3.84
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
Prucalopride
Manufacturer
Ajanta Pharma USA Inc.
Country
United States (US)
ATC code
A06AX05
ATC class
Prucalopride
Defined daily dose
2 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
    2724129530
    30 TABLET in 1 BOTTLE (27241-295-30)

Regulatory notes

UNII (FDA substance ID)
0A09IUW5TP
PRUCALOPRIDE
RxCUI 2107310
Orange Book
A219220
ABAB
DailyMed SPL labels
1 version tracked

Interactions

127 interactions on record for prucalopride.

Graded by severity as the source publishes them — 57 moderate. 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

Prucalopride · interactions on record

127 records

  • 57 moderate
  • 70 minor

Most severe, free to view

  • DicycloverineA03AA07moderate
  • PropanthelineA03AB05moderate
  • MepenzolateA03AB12moderate
  • TrospiumA03AB20moderate
  • 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

Prucalopride in 15 other countries

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

All prucalopride products

Authorised across Europe · EMA

The same active substance is authorised in 21 EEA countries. Names it is sold under:

  • Belgium · Prucalopride Fagron, Prucalopride Koanaa Healthcare
  • Bulgaria · Енилис, Стеркор
  • Cyprus · Absken, Stercore
  • Germany · Prucaloprid Al, Prucaloprid Aristo
  • Denmark · Prucalopride "holsten", Prucalopride Amarox
  • Finland · Prucalopride Stada
  • France · Prucalopride Amarox
  • United Kingdom (Northern Ireland) · Prucalopride, Prucalopride Amarox
  • Greece · Absken
  • Croatia · Abemot, Colopridix
  • Hungary · Prucalopride Supremex, Tsatsago
  • Ireland · Prucalopride, Prucalopride Aristo
  • Iceland · Prucalopride Stada, Pucalopride Stada
  • Liechtenstein · Resolor
  • Malta · Absken, Colopridix
  • Netherlands · Prucalopride Amarox, Prucalopride Fagron
  • Norway · Prucalopride Orifarm, Prucalopride Zentiva
  • Romania · Colselax, Stercore
  • Sweden · Prucalopride Amarox, Prucalopride Axunio
  • Slovenia · Colopridix
  • Slovakia · Stercore

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/718662af-7801-4fd4-b049-da37cff29cc5
GET /v1/drugs/718662af-7801-4fd4-b049-da37cff29cc5?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": "0A09IUW5TP",
    "rxcui": "2107310",
    "inchikey": "ZPMNHBXQOOVQJL-UHFFFAOYSA-N",
    "display_name": "PRUCALOPRIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "livertox": {
    "summary": null,
    "livertox_id": null,
    "hepatotoxicity_score": 5
  },
  "spl_meta": {
    "af559917-802b-486c-9f7b-b770115acac8": {
      "match": "brand_token",
      "title": "PRUCALOPRIDE TABLET, FILM COATED [VIONA PHARMACEUTICALS INC]",
      "spl_version": "1",
      "published_date": "2026-02-02"
    }
  },
  "productid": "27241-295_ac2afe93-a78a-4dfe-8759-fec53f872e35",
  "productndc": "27241-295",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "219220",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 1MG BASE",
        "product_no": "001",
        "approval_date": "Jan 16, 2026"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2MG BASE",
        "product_no": "002",
        "approval_date": "Jan 16, 2026"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PRUCALOPRIDE",
  "proprietary_name": "Prucalopride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA219220",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Prucalopride",
  "start_marketing_date": "20260116",
  "active_numerator_strength": "2"
}

See everything about prucalopride.

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.