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Prescription medicine

Albumin human

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

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Quick answers

What is Albumin human used for?
The FDA-approved label (Albuminex, Bpl, December 31, 2024) says: “ALBUMINEX 25% is a 25% albumin solution indicated for adults and children: Hypovolemia Ascites Hypoalbuminemia including from burns Acute Nephrosis Acute Respiratory Distress Syndrome (ARDS) Cardiopulmonary Bypass 1.1 Hypovolemia ALBUMINEX 25% is indicated for restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated, and use of a colloid is appropriate e.g. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Albumin human have a boxed warning?
No. None of the 2 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Albumin human?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Albumin human been recalled?
No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
Who makes Albumin human?
1 company lists prescription products of Albumin human in the FDA NDC Directory, including BPL.

What Albumin human is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

ALBUMINEX 25% is a 25% albumin solution indicated for adults and children: Hypovolemia Ascites Hypoalbuminemia including from burns Acute Nephrosis Acute Respiratory Distress Syndrome (ARDS) Cardiopulmonary Bypass 1.1 Hypovolemia ALBUMINEX 25% is indicated for restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated, and use of a colloid is appropriate e.g. …

— FDA label: Albuminex, Bpl, effective December 31, 2024. Read the full label on DailyMed →

The FDA has 2 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Conditions named on the label

These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.

Related medical specialties

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

0 of 2 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsSolution
RouteIntravenous
Prescription products2 in the FDA NDC Directory
Brand namesAlbuminex

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

FDA approval history

  • BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
BLA125644 —Date not on file —

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.

Official identifiers

RxCUI (RxNorm)2054168, 2054170, 2054173, 2054174, 2054221, 2054223, 2054226, 2054227
SPL set ID of the quoted label167f48d0-8ae5-4f7e-b050-9673dad78acc
FDA labels (SPL)2
FDA applicationsBLA125644
Active ingredients (FDA)ALBUMIN HUMAN

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Albuminex, Bpl, effective December 31, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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