Quick answers
- What is Hepatitis b immune globulin (human) used for?
- The FDA-approved label (Nabi-HB, ADMA Biologics, Inc., April 10, 2025) says: “Nabi-HB, Hepatitis B Immune Globulin (Human), is indicated for treatment of acute exposure to blood containing HBsAg, perinatal exposure of infants born to HBsAg-positive mothers, sexual exposure to HBsAg-positive persons and household exposure to persons with acute HBV infec- tion in the following settings: Acute Exposure to Blood Containing HBsAg …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Hepatitis b immune globulin (human) have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Hepatitis b immune globulin (human)?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Hepatitis b immune globulin (human) been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Hepatitis b immune globulin (human)?
- 1 company lists prescription products of Hepatitis b immune globulin (human) in the FDA NDC Directory, including ADMA Biologics, Inc..
What Hepatitis b immune globulin (human) is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Nabi-HB, Hepatitis B Immune Globulin (Human), is indicated for treatment of acute exposure to blood containing HBsAg, perinatal exposure of infants born to HBsAg-positive mothers, sexual exposure to HBsAg-positive persons and household exposure to persons with acute HBV infec- tion in the following settings: Acute Exposure to Blood Containing HBsAg …
— FDA label: Nabi-HB, ADMA Biologics, Inc., effective April 10, 2025. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
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.
Forms and how it is given
| Dosage forms | Liquid |
|---|---|
| Route | Intramuscular |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Nabi-Hb |
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.
- ADMA Biologics, Inc.1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA103945 | — | Date not on file | — |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 1658125, 1658127 |
|---|---|
| SPL set ID of the quoted label | 47fe1a99-5078-4b89-84fa-9e8387baec5c |
| FDA labels (SPL) | 1 |
| FDA applications | BLA103945 |
| Active ingredients (FDA) | HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Nabi-HB, ADMA Biologics, Inc., effective April 10, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- 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 →