Medicine
BabyBIG 50 mg/mL powder for injection
BabyBIG 50 mg/mL powder for injection is a prescription medicine containing Human botulinum neurotoxin a/b immune globulin for intravenous use, marketed by California Department of Public Health, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
Store the vial containing the lyophilized product between 2° and 8°C (35.6° to…
Key facts
- Active ingredient (INN)
- Human botulinum neurotoxin a/b immune globulin
- Brand
- BabyBIG
- Strength
- 50 mg/mL
- Dosage form
- Powder for injection
- Route
- Intravenous
- Packs
- 1 vial
- Marketing authorisation holder
- California Department of Public Health
- Manufacturer
- California Department of Public Health
- Origin register
- US FDA, United States
- Storage
- Store the vial containing the lyophilized product between 2° and 8°C (35.6° to 46.4°F). Do not store BabyBIG in the reconstituted state.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3002.12Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 23 October 2003
- Identifiers
- RxCUI 544491, 544495DailyMed set ID 9ec59262-35c1-4d8e-8451-a7cfbacb0675NDC 68403-1100Application BLA125034
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 vial, single-use in 1 carton / 2 mL in 1 vial, single-use | 68403-1100-7 | California Department of Public Health | 23 October 2003 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Clinical summary
Human botulinum neurotoxin a/b immune globulin is a human immunoglobulin G indicated for the treatment of infant botulism caused by toxin type A or B in patients below one year of age. MedsAcross supplies Human botulinum neurotoxin a/b immune globulin for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about Human botulinum neurotoxin a/b immune globulinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- BabyBIG prescribing information (California Department of Public Health) · U.S. National Library of Medicine, DailyMed
Need BabyBIG 50 mg/mL powder for injection for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.