United States· US:0944-2884_312a9f40-d4bd-4cc2-810a-2df7d7baead8

GLASSIA

A medicinal product containing .alpha.1-proteinase inhibitor human, registered in United States by Takeda Pharmaceuticals America, 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…normalisedGLASSIAATC—REGISTER NO.US:0944-2884_312a9f40…PACKS LISTED6CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
.ALPHA.1-PROTEINASE INHIBITOR HUMAN
Manufacturer
Takeda Pharmaceuticals America, 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 · 6

  • ndc11
    0944288401
    1 VIAL, GLASS in 1 CARTON (0944-2884-01) / 50 mL in 1 VIAL, GLASS (0944-2884-02)
  • ndc11
    0944288403
    1 VIAL, GLASS in 1 CARTON (0944-2884-03) / 200 mL in 1 VIAL, GLASS (0944-2884-04)
  • ndc11
    0944288405
    1 VIAL, GLASS in 1 CARTON (0944-2884-05) / 250 mL in 1 VIAL, GLASS (0944-2884-06)
  • ndc11
    0944-2884-01
  • ndc11
    0944-2884-03
  • ndc11
    0944-2884-05

Regulatory notes

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

Same medicine, other countries

.alpha.1-proteinase inhibitor human in 12 other countries

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

All .alpha.1-proteinase inhibitor human products

Authorised across Europe · EMA

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

  • Austria · Prolastin
  • Belgium · Pulmolast
  • Cyprus · Prolastina
  • Czechia · Prolastina
  • Germany · Prolastin
  • Denmark · Prolastina
  • Spain · Prolasplan, Prolastina
  • Finland · Prolastina
  • France · Alfalastin, Prolastin
  • Greece · Prolastin
  • Croatia · Prolastina
  • Ireland · Prolastin
  • Iceland · Respreeza
  • Italy · Plitalfa, Prolastin
  • Liechtenstein · Respreeza
  • Netherlands · Prolastin
  • Norway · Prolastina, Respreeza
  • Poland · Prolastin, Prolastin, 4000 Mg
  • Portugal · Prolastin
  • Sweden · Prolastina
  • Slovakia · Prolastina

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/77868d38-9e1f-4cb5-945f-f3ad7bc0bc86
GET /v1/drugs/77868d38-9e1f-4cb5-945f-f3ad7bc0bc86?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": "INTRAVENOUS",
  "source": "ndc",
  "strength": "1",
  "substance": ".ALPHA.1-PROTEINASE INHIBITOR HUMAN",
  "productndc": "0944-2884",
  "dosage_form": "INJECTION, SOLUTION",
  "dea_schedule": null,
  "strength_unit": "g/50mL",
  "application_number": "BLA125325",
  "marketing_category": "BLA"
}

See everything about .alpha.1-proteinase inhibitor human.

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.