United States· US:13533-705_f3f69bd6-df32-45c4-bbd9-b18b0d725382

Prolastin-C Liquid

A medicinal product containing .alpha.1-proteinase inhibitor human, registered in United States by GRIFOLS USA, LLC.

Checked against FDA National Drug Code directory (United States) on September 27, 2026

Informational only — not a medical device.

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The record

At a glance

FDA National Drug Code directory (United States)

Active substance: .ALPHA.1-PROTEINASE INHIBITOR HUMAN
Manufacturer: GRIFOLS USA, LLC
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
1353370501
1 VIAL in 1 CARTON (13533-705-01) / 20 mL in 1 VIAL (13533-705-11)
ndc11
1353370531
1 VIAL in 1 CARTON (13533-705-31) / 10 mL in 1 VIAL (13533-705-32)
ndc11
1353370551
1 VIAL in 1 CARTON (13533-705-51) / 80 mL in 1 VIAL (13533-705-52)
ndc11
13533-705-51
ndc11
13533-705-01
ndc11
13533-705-31

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/fd019709-bbbc-4fce-8b4a-3e563ffa43bb
GET /v1/drugs/fd019709-bbbc-4fce-8b4a-3e563ffa43bb?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": "1000",
  "substance": ".ALPHA.1-PROTEINASE INHIBITOR HUMAN",
  "productndc": "13533-705",
  "dosage_form": "INJECTION, SOLUTION",
  "dea_schedule": null,
  "strength_unit": "mg/20mL",
  "application_number": "BLA103174",
  "marketing_category": "BLA"
}

API reference MCP server Plans

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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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