Prescription medicine
Human botulinum neurotoxin a b immune globulin Brand names: Babybig
Human botulinum neurotoxin a b immune globulin (Babybig) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the human botulinum neurotoxin a b immune globulin FDA label on DailyMed (effective December 8, 2025); every human botulinum neurotoxin a b immune globulin label on DailyMed.
Highlights of the record
FDA label of December 8, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageBabyBIG ® , Botulism Immune Globulin Intravenous (Human), is indicated for the treatment of infant botulism caused by toxin type A or B in patients below one year of age.
Forms and strengths
- 50 mg/ml
Injection (powder) (lyophilized) for solution.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 38 through July 30, 2026
What is human botulinum neurotoxin a b immune globulin used for?
From the label: indications and usageBabyBIG ® , Botulism Immune Globulin Intravenous (Human), is indicated for the treatment of infant botulism caused by toxin type A or B in patients below one year of age. BabyBIG is an immune globulin intravenous (human) indicated for: Treatment of infant botulism caused by toxin types A or B in patients below one year of age ( 1 ).
FDA pharmacologic class: Human Immunoglobulin G.
Source: FDA drug label (BabyBIG), CALIFORNIA DEPARTMENT OF PUBLIC HEALTH, effective December 8, 2025 (SPL set 9ec59262-35c1-4d8e-8451-a7cfbacb0675), via openFDA; the full label on DailyMed
Is there a generic for human botulinum neurotoxin a b immune globulin (Babybig)?
No generic human botulinum neurotoxin a b immune globulin is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the human botulinum neurotoxin a b immune globulin label say about other medicines?
The human botulinum neurotoxin a b immune globulin label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Epinephrine | warnings and precautions | A reaction may be related to the rate of infusion; therefore, carefully adhere to the infusion rates as outlined under "DOSAGE AND ADMINISTRATION (2.3)." If anaphylaxis or a drop in blood pressure occurs, discontinue the infusion and administer epinephrine. … |
Check human botulinum neurotoxin a b immune globulin against other medicines
Source: FDA drug label (BabyBIG), CALIFORNIA DEPARTMENT OF PUBLIC HEALTH, effective December 8, 2025 (SPL set 9ec59262-35c1-4d8e-8451-a7cfbacb0675), via openFDA; the full label on DailyMed
What do FAERS reports show for human botulinum neurotoxin a b immune globulin?
The FDA Adverse Event Reporting System holds 38 reports that list human botulinum neurotoxin a b immune globulin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 6 are coded as a death and 16 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other human immunoglobulin gs
- the pharmacologic class, with prices and generics
- Human botulinum neurotoxin a b immune globulin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other