United States· US:61476-104_5d39e5bd-c8a4-4dab-a3c3-ca13ac44b3b0

Alyglo

A medicinal product containing human immunoglobulin g, registered in United States by GC Biopharma Corp..

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…normalisedAlygloATC—REGISTER NO.US:61476-104_5d39e5bd…PACKS LISTED3CHECKEDJune 3, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
Human immunoglobulin G
Manufacturer
GC Biopharma Corp.
Country
United States (US)
ATC code
—
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
June 3, 2026

Packs & prices · 3

  • ndc11
    6147610405
    1 VIAL, GLASS in 1 CARTON (61476-104-05) / 50 mL in 1 VIAL, GLASS (61476-104-01)
  • ndc11
    6147610410
    1 VIAL, GLASS in 1 CARTON (61476-104-10) / 100 mL in 1 VIAL, GLASS (61476-104-02)
  • ndc11
    6147610420
    1 VIAL, GLASS in 1 CARTON (61476-104-20) / 200 mL in 1 VIAL, GLASS (61476-104-03)

Regulatory notes

UNII (FDA substance ID)
66Y330CJHS
HUMAN IMMUNOGLOBULIN G
RxCUI 1426680
DailyMed SPL labels
1 version tracked

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/1d67f7de-27bc-41cb-ae52-a665f45dba36
GET /v1/drugs/1d67f7de-27bc-41cb-ae52-a665f45dba36?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": "66Y330CJHS",
    "rxcui": "1426680",
    "inchikey": null,
    "display_name": "HUMAN IMMUNOGLOBULIN G",
    "substance_type": "structurallyDiverse",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "fb97b3ec-29ee-4df1-aa99-c23e57a21228": {
      "match": "brand_token",
      "title": "ALYGLO (HUMAN IMMUNOGLOBULIN G) LIQUID [GC BIOPHARMA CORP.]",
      "spl_version": "4",
      "published_date": "2025-12-16"
    }
  },
  "productid": "61476-104_5d39e5bd-c8a4-4dab-a3c3-ca13ac44b3b0",
  "productndc": "61476-104",
  "dosage_form": "LIQUID",
  "dea_schedule": null,
  "product_type": "PLASMA DERIVATIVE",
  "substance_name": "HUMAN IMMUNOGLOBULIN G",
  "proprietary_name": "Alyglo",
  "active_ingred_unit": "mg/mL",
  "application_number": "BLA125743",
  "marketing_category": "BLA",
  "nonproprietary_name": "Human immunoglobulin G",
  "start_marketing_date": "20231215",
  "active_numerator_strength": "100"
}

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.