United States· US:68516-5214_e078cf18-faac-4ebe-915a-acf9c1af960e
ALBUTEIN
A medicinal product containing albumin human, 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
- ALBUMIN HUMAN
- 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
- ndc1168516-5214-5
- ndc1168516521411 VIAL in 1 CARTON (68516-5214-1) / 250 mL in 1 VIAL (68516-5214-3)
- ndc1168516521421 VIAL in 1 CARTON (68516-5214-2) / 500 mL in 1 VIAL (68516-5214-4)
- ndc1168516521451 VIAL in 1 CARTON (68516-5214-5) / 50 mL in 1 VIAL (68516-5214-6)
- ndc1168516-5214-1
- ndc1168516-5214-2
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Albumin human in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaALBUNORMOctapharma (IP) SPRL, Anderlecht
- FinlandAlbumin BaxaltaBaxalta Innovations GmbH
- BelgiumAlburex 5 50 mg/mlCSL Behring
- IcelandAlbumin BaxaltaBaxalta Innovations GmbH
- PolandAlbunorm 5%Octapharma (IP) SPRL
- United KingdomAlba 20% solution for infusion 100ml bottlesScottish National Blood Transfusion Service
- Japan人血清アルブミン武田薬品工業
- GermanyAlbiominBiotest Pharma Gmbh
Authorised across Europe · EMA
The same active substance is authorised in 30 EEA countries. Names it is sold under:
- Austria · Albiomin, Albunorm
- Belgium · Albunorm, Human Albumin Baxalta
- Bulgaria · Aлбунорм, Албиомин
- Cyprus · Albiomin, Albuman
- Czechia · Albunorm, Albutein
- Germany · Albiomin, Albunorm
- Denmark · Albumin Baxalta, Albumin Grifols
- Estonia · Albumin Baxalta, Albunorm
- Spain · Albiomin, Albuplan
- Finland · Albuman, Albumin Baxalta
- France · Albumine Humaine, Albunorm
- United Kingdom (Northern Ireland) · Albunorm, Albutein
- Greece · Albiomin, Albumine Lfb
- Croatia · Albutein, Flexbumin
- Hungary · Albumon, Albunorm
- Ireland · Albunorm, Albutein
- Iceland · Albuman, Albumin Baxalta
- Italy · Albiomin, Albital
- Lithuania · Albumin Baxalta, Albunorm
- Luxembourg · Albunorm, Human Albumin Baxalta
- Latvia · Albumin Baxalta, Albunorm
- Malta · Albiomin, Albunorm
- Netherlands · Albuman, Albunorm
- Norway · Albumin Baxalta, Albumin Grifols
- Poland · Albiomin, Albunorm
- Portugal · Albiomin, Albumina Humana Baxalta
- Romania · Albiomin, Albumină Umană Baxalta
- Sweden · Albumin Baxalta, Albumin Octapharma
- Slovenia · Albunorm, Flexbumin
- Slovakia · Albunorm, Albutein
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/a251f314-195a-4429-9fd9-a3178ee286fc GET /v1/drugs/a251f314-195a-4429-9fd9-a3178ee286fc?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": "12.5",
"substance": "ALBUMIN HUMAN",
"productndc": "68516-5214",
"dosage_form": "INJECTION, SOLUTION",
"dea_schedule": null,
"strength_unit": "g/250mL",
"application_number": "BLA102478",
"marketing_category": "BLA"
}See everything about albumin human.
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.