United States· US:49591-051_4c139c86-d0dc-1a10-e063-6294a90a8e1d

HepaGam B

A medicinal product containing human hepatitis b virus immune globulin, registered in United States by Kamada Ltd..

US label

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: HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN
Manufacturer: Kamada Ltd.
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 · 2

ndc11
4959105151
1 VIAL, GLASS in 1 CARTON (49591-051-51) / 5 mL in 1 VIAL, GLASS (49591-051-05)
ndc11
49591-051-51

Regulatory notes

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

Same medicine, other countries

Human hepatitis b virus immune globulin in 7 other countries

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

All human hepatitis b virus immune globulin products

Authorised across Europe · EMA

The same active substance is authorised in 26 EEA countries. Names it is sold under:

Austria · Hepatect Cp, Uman Big
Belgium · Hepacaf, Neohepatect
Bulgaria · Хепатект Ср
Czechia · Neohepatect
Germany · Fovepta, Hepatect Cp
Denmark · Hepatect Cp, Uman Big
Spain · Hepatect, Igantibe
Finland · Hepatect
France · Immunoglobuline Humaine De L'hepatite B Lfb, Ivhebex
United Kingdom (Northern Ireland) · Hepatect Cp, Human Hepatitis B Immunoglobulin Bio Products Laboratory
Greece · Hepatect Cp, Venbig
Croatia · Hepatect Cp, Venbig
Hungary · Umanbig, Venbig
Ireland · Hepatect Cp
Iceland · Zutectra
Italy · Igantibe, Immunohbs
Liechtenstein · Zutectra
Lithuania · Hepetra
Netherlands · Hepatect Cp, Uman Big
Norway · Hepatect, Umanbig
Poland · Gamma Anty-Hbs 200, Hepatect Cp
Portugal · Gammaglobulina Antihepatitis B P Behring, Hepatect Cp
Romania · Hepatect Cp
Sweden · Neohepatect, Umanbig
Slovenia · Hepatect Cp
Slovakia · Igantibe

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/1a9488ba-8fd5-4e5d-8884-9604f8c4c522
GET /v1/drugs/1a9488ba-8fd5-4e5d-8884-9604f8c4c522?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; INTRAVENOUS",
  "source": "ndc",
  "strength": "312",
  "substance": "HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN",
  "productndc": "49591-051",
  "dosage_form": "INJECTION, SOLUTION",
  "dea_schedule": null,
  "strength_unit": "[iU]/mL",
  "application_number": "BLA125035",
  "marketing_category": "BLA"
}

API reference MCP server Plans

See everything about human hepatitis b virus immune globulin.

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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