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United States· US:0562-7805_7ccbaf67-ab6a-490a-9b63-598d75a7afca

RhoGAM Ultra-Filtered PLUS

A medicinal product containing human rho(d) immune globulin, registered in United States by Kedrion Biopharma Inc.

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…normalisedRhoGAM Ultra-Filtered PLUSATC—REGISTER NO.US:0562-7805_7ccbaf67…PACKS LISTED6CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
HUMAN RHO(D) IMMUNE GLOBULIN
Manufacturer
Kedrion Biopharma Inc
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

  • ndc11
    0562780501
    1 POUCH in 1 CARTON (0562-7805-01) / 1 INJECTION, SOLUTION in 1 POUCH (0562-7805-00)
  • ndc11
    0562780505
    5 POUCH in 1 CARTON (0562-7805-05) / 1 INJECTION, SOLUTION in 1 POUCH (0562-7805-00)
  • ndc11
    0562780525
    25 POUCH in 1 CARTON (0562-7805-25) / 1 INJECTION, SOLUTION in 1 POUCH (0562-7805-00)
  • ndc11
    0562-7805-01
  • ndc11
    0562-7805-05
  • ndc11
    0562-7805-25

Regulatory notes

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

Same medicine, other countries

Human rho(d) immune globulin in 16 other countries

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

All human rho(d) immune globulin products

Authorised across Europe · EMA

The same active substance is authorised in 29 EEA countries. Names it is sold under:

  • Austria · Rhesonativ, Rhophylac
  • Belgium · Immunorho, Rhophylac
  • Bulgaria · Резонатив
  • Cyprus · Rhesonativ, Rhophylac
  • Czechia · Igamad, Rhesonativ
  • Germany · Rhesonativ, Rhophylac
  • Denmark · Rhesonativ, Rhophylac
  • Estonia · Rhesonativ
  • Spain · Igamad, Rhophylac
  • Finland · Rhophylac
  • France · Rhesonativ, Rhophylac
  • United Kingdom (Northern Ireland) · D-Gam, Rhophylac
  • Greece · Rhophylac
  • Hungary · Rhesonativ, Rhophylac
  • Ireland · Rhophylac
  • Iceland · Rhesonativ, Rhophylac
  • Italy · Igamad, Immunorho
  • Lithuania · Rhesonativ
  • Luxembourg · Rhesonativ, Rhophylac
  • Latvia · Rhesonativ
  • Malta · Rhesonativ, Rhophylac
  • Netherlands · Rhesonativ, Rhophylac
  • Norway · Rhesonativ, Rhophylac
  • Poland · Gamma Anty-D, Rhesonativ
  • Portugal · Rhesonativ, Rhophylac
  • Romania · Rhesonativ, Rhophylac
  • Sweden · Rhesonativ, Rhophylac
  • Slovenia · Rhesonativ, Rhophylac
  • Slovakia · Igamad, Rhesonativ

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/5122821e-5b80-49e0-8f82-bc796f7c86fb
GET /v1/drugs/5122821e-5b80-49e0-8f82-bc796f7c86fb?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": "300",
  "substance": "HUMAN RHO(D) IMMUNE GLOBULIN",
  "productndc": "0562-7805",
  "dosage_form": "INJECTION, SOLUTION",
  "dea_schedule": null,
  "strength_unit": "ug/1",
  "application_number": "BLA103777",
  "marketing_category": "BLA"
}

See everything about human rho(d) 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.