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United States· US:13533-636_07a45b19-8ed3-48e2-9c0f-9620437fd452

HYPERHEP B

A medicinal product containing human hepatitis b virus immune globulin, registered in United States by GRIFOLS USA, LLC.

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…normalisedHYPERHEP BATC—REGISTER NO.US:13533-636_07a45b19…PACKS LISTED8CHECKEDSeptember 27, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about human hepatitis b virus immune globulinAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN
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 · 8

  • ndc11
    1353363601
    1 VIAL, GLASS in 1 CARTON (13533-636-01) / 1 mL in 1 VIAL, GLASS (13533-636-10)
  • ndc11
    1353363602
    1 SYRINGE, GLASS in 1 CARTON (13533-636-02) / 1 mL in 1 SYRINGE, GLASS (13533-636-20)
  • ndc11
    1353363603
    1 SYRINGE, GLASS in 1 CARTON (13533-636-03) / .5 mL in 1 SYRINGE, GLASS (13533-636-30)
  • ndc11
    1353363605
    1 VIAL, GLASS in 1 CARTON (13533-636-05) / 5 mL in 1 VIAL, GLASS (13533-636-50)
  • ndc11
    13533-636-01
  • ndc11
    13533-636-02
  • ndc11
    13533-636-03
  • ndc11
    13533-636-05

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/6a171ec9-5ca6-41fb-8b2f-e232ec7e92ac
GET /v1/drugs/6a171ec9-5ca6-41fb-8b2f-e232ec7e92ac?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": "220",
  "substance": "HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN",
  "productndc": "13533-636",
  "dosage_form": "INJECTION",
  "dea_schedule": null,
  "strength_unit": "[iU]/mL",
  "application_number": "BLA101146",
  "marketing_category": "BLA"
}
API referenceMCP serverPlans

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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