United States· US:61953-0004_6c2e3e83-43fe-48d2-b6a6-7b78870210b7
Flebogamma
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 · 6
- ndc1161953-0004-3
- ndc1161953-0004-4
- ndc1161953-0004-5
- ndc1161953000431 VIAL in 1 CARTON (61953-0004-3) / 100 mL in 1 VIAL (61953-0004-8)
- ndc1161953000441 VIAL in 1 CARTON (61953-0004-4) / 200 mL in 1 VIAL (61953-0004-9)
- ndc1161953000451 VIAL in 1 CARTON (61953-0004-5) / 400 mL in 1 VIAL (61953-0004-0)
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.
- BelgiumFlebogamma DIF 50 mg/mlInstituto Grifols
- SpainFLEBOGAMMA DIF 50 mg/ml SOLUCION PARA PERFUSIONInstituto Grifols S.A.
- FinlandFlebogamma DifInstituto Grifols S.A.
- PolandIg VenaKedrion S.p.A.
- SwedenFlebogamma DIF 50 mg/ml Infusionsvätska, lösningInstituto Grifols SA
- IcelandFlebogamma DIFInstituto Grifols S.A.*
- NorwayOctagamOctapharma (2)
- IrelandFlebogamma DIF 50 mg/ml solution for infusionInstituto Grifols S.A.
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/222ecfae-e10b-4c07-a640-da118d996a53 GET /v1/drugs/222ecfae-e10b-4c07-a640-da118d996a53?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": ".05",
"substance": "HUMAN IMMUNOGLOBULIN G",
"productndc": "61953-0004",
"dosage_form": "INJECTION, SOLUTION",
"dea_schedule": null,
"strength_unit": "g/mL",
"application_number": "BLA125077",
"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.