Quick answers
- What is Bivigam?
- Bivigam is a brand name of Human immunoglobulin g, a prescription medicine. The FDA NDC Directory lists 2 Bivigam products in 2 strengths and forms.
- Who makes Bivigam?
- ADMA Biologics, Inc. lists 2 of the 2 Bivigam products in the FDA NDC Directory.
- Is there a generic or store brand of Bivigam?
- Yes. The FDA NDC Directory lists 1 other product with the same active ingredients, strength and form as a Bivigam product. Ask your pharmacist whether one is right for you.
- Has Bivigam been recalled?
- No recall linked to Bivigam products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Bivigam is
Each Bivigam product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Human immunoglobulin g · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| human immunoglobulin g 10% injection, solution (intravenous) | Bivigam | None listed | — |
| human immunoglobulin g 5 g/50 mL injection, solution (intravenous) | Bivigam | 1 product, 1 company | — |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Human immunoglobulin g →
FDA approval
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| BLA125389 | — | Date not on file | 2 |
Companies that list Bivigam
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Bivigam products.
- ADMA Biologics, Inc.2 products
Recalls
No recall linked to Bivigam products (by their NDC code or label) appears in the FDA enforcement reports.
Sources
- 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 labeling (SPL, 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
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.