United States· US:10122-510_6b713a41-2648-43f4-9a10-cc41a7e83ca0

Curosurf

A medicinal product containing poractant alfa, registered in United States by Chiesi USA, Inc..

US 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…normalisedCurosurfATC—REGISTER NO.US:10122-510_6b713a41…PACKS LISTED4CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
PORACTANT ALFA
Manufacturer
Chiesi USA, 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 27, 2026

Packs & prices · 4

  • ndc11
    1012251001
    1.5 mL in 1 VIAL, GLASS (10122-510-01)
  • ndc11
    1012251003
    3 mL in 1 VIAL, GLASS (10122-510-03)
  • ndc11
    10122-510-01
  • ndc11
    10122-510-03

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Same medicine, other countries

Poractant alfa in 9 other countries

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

All poractant alfa products

Authorised across Europe · EMA

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

  • Austria · Curosurf
  • Belgium · Curosurf
  • Bulgaria · Куросърф
  • Cyprus · Curosurf
  • Czechia · Curosurf
  • Denmark · Curosurf
  • Estonia · Curosurf
  • Spain · Curosurf
  • Finland · Curosurf
  • France · Curosurf
  • United Kingdom (Northern Ireland) · Curosurf
  • Greece · Curosurf
  • Croatia · Curosurf
  • Hungary · Curosurf
  • Ireland · Curosurf
  • Iceland · Curosurf
  • Italy · Curosurf
  • Lithuania · Curosurf
  • Luxembourg · Curosurf
  • Latvia · Curosurf
  • Malta · Curosurf
  • Netherlands · Curosurf
  • Norway · Curosurf
  • Poland · Curosurf
  • Portugal · Curosurf
  • Romania · Curosurf
  • Sweden · Curosurf
  • Slovenia · Curosurf
  • Slovakia · Curosurf

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/5df20b29-ca75-4180-aeb4-e7f91daae215
GET /v1/drugs/5df20b29-ca75-4180-aeb4-e7f91daae215?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": "ENDOTRACHEAL",
  "source": "ndc",
  "strength": "80",
  "substance": "PORACTANT ALFA",
  "productndc": "10122-510",
  "dosage_form": "SUSPENSION",
  "dea_schedule": null,
  "strength_unit": "mg/mL",
  "application_number": "BLA020744",
  "marketing_category": "BLA"
}

See everything about poractant alfa.

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.