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United States· US:0944-2850_195585b0-5cd1-4638-9765-224db70d6e44

CUVITRU

A medicinal product containing human immunoglobulin g, 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…normalisedCUVITRUATC—REGISTER NO.US:0944-2850_195585b0…PACKS LISTED10CHECKEDSeptember 27, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about human immunoglobulin gAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
HUMAN IMMUNOGLOBULIN G
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 · 10

  • ndc11
    0944285001
    1 VIAL, SINGLE-USE in 1 CARTON (0944-2850-01) / 5 mL in 1 VIAL, SINGLE-USE (0944-2850-02)
  • ndc11
    0944285003
    1 VIAL, SINGLE-USE in 1 CARTON (0944-2850-03) / 10 mL in 1 VIAL, SINGLE-USE (0944-2850-04)
  • ndc11
    0944285005
    1 VIAL, SINGLE-USE in 1 CARTON (0944-2850-05) / 20 mL in 1 VIAL, SINGLE-USE (0944-2850-06)
  • ndc11
    0944285007
    1 VIAL, SINGLE-USE in 1 CARTON (0944-2850-07) / 40 mL in 1 VIAL, SINGLE-USE (0944-2850-08)
  • ndc11
    0944285009
    1 BOTTLE, GLASS in 1 CARTON (0944-2850-09) / 50 mL in 1 BOTTLE, GLASS (0944-2850-10)
  • ndc11
    0944-2850-01
  • ndc11
    0944-2850-03
  • ndc11
    0944-2850-05
  • ndc11
    0944-2850-07
  • ndc11
    0944-2850-09

Regulatory notes

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

Same medicine, other countries

Human immunoglobulin g in 12 other countries

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

All human immunoglobulin g products

Authorised across Europe · EMA

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

  • Austria · Cutaquig, Cuvitru
  • Belgium · Cutaquig, Cuvitru
  • Bulgaria · Имуновенин, Интратект
  • Cyprus · Gamunex, Intratect
  • Czechia · Cutaquig, Cuvitru
  • Germany · Beriglobin, Cutaquig
  • Denmark · Cutaquig, Cuvitru
  • Estonia · Cutaquig, Gammanorm
  • Spain · Cutaquig, Cuvitru
  • Finland · Cutaquig, Cuvitru
  • France · Clairyg, Cutaquig
  • United Kingdom (Northern Ireland) · Cutaquig, Cuvitru
  • Greece · Gaminex, Ig Vena
  • Croatia · Cutaquig, Ig Vena
  • Hungary · Cutaquig, Gammanorm
  • Ireland · Cutaquig, Cuvitru
  • Iceland · Cutaquig, Deqsiga
  • Italy · Cutaquig, Cuvitru
  • Liechtenstein · Deqsiga, Flebogamma Dif
  • Lithuania · Cutaquig, Gammanorm
  • Luxembourg · Cutaquig, Gammagard S/D (Solvent/Detergent)
  • Latvia · Cutaquig, Gammanorm
  • Malta · Cutaquig, Gammanorm
  • Netherlands · Cutaquig, Cuvitru
  • Norway · Cutaquig, Cuvitru
  • Poland · Cutaquig, Cuvitru
  • Portugal · Cutaquig, Gammanorm
  • Romania · Cutaquig, Gammanorm
  • Sweden · Cutaquig, Cuvitru
  • Slovenia · Cutaquig, Gammanorm
  • Slovakia · Cutaquig, Cuvitru

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/00572195-4976-43fb-a4be-cbf74d6fd82a
GET /v1/drugs/00572195-4976-43fb-a4be-cbf74d6fd82a?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": "SUBCUTANEOUS",
  "source": "ndc",
  "strength": "200",
  "substance": "HUMAN IMMUNOGLOBULIN G",
  "productndc": "0944-2850",
  "dosage_form": "INJECTION, SOLUTION",
  "dea_schedule": null,
  "strength_unit": "mg/mL",
  "application_number": "BLA125596",
  "marketing_category": "BLA"
}
API referenceMCP serverPlans

See everything about human immunoglobulin g.

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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