United States· US:13533-635_10baba80-5b1a-47f4-aedd-5f36a7d0c331
GAMASTAN
A medicinal product containing human immunoglobulin g, registered in United States by GRIFOLS USA, LLC.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- HUMAN IMMUNOGLOBULIN G
- 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 · 4
- ndc1113533635041 VIAL in 1 CARTON (13533-635-04) / 2 mL in 1 VIAL (13533-635-40)
- ndc1113533635121 VIAL in 1 CARTON (13533-635-12) / 10 mL in 1 VIAL (13533-635-13)
- ndc1113533-635-04
- ndc1113533-635-12
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.
- BelgiumCutaquig 165 mg/mlOctapharma Benelux
- SpainBERIGLOBINA PCsl Behring S.A.
- FinlandCutaquigOctapharma AB
- SwedenBeriglobin 160 mg/ml Injektionsvätska, lösning i förfylld sprutaCSL Behring GmbH
- CzechiaGAMMANORMOctapharma (IP) SPRL, Brusel
- JapanｐＨ４処理酸性人免疫グロブリン（皮下注射）武田薬品工業
- GermanyBeriglobinCsl Behring Gmbh
- IcelandCutaquigOctapharma AB
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/02d5410e-9579-4199-bdda-df29f223bdef GET /v1/drugs/02d5410e-9579-4199-bdda-df29f223bdef?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": "INTRAMUSCULAR",
"source": "ndc",
"strength": ".165",
"substance": "HUMAN IMMUNOGLOBULIN G",
"productndc": "13533-635",
"dosage_form": "INJECTION, SOLUTION",
"dea_schedule": null,
"strength_unit": "g/mL",
"application_number": "BLA101134",
"marketing_category": "BLA"
}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.